I will also need a draft from each section every week.

 

Managing Pain in the Adult Patient Undergoing Shoulder Surgery

Your Name

Fairleigh Dickinson University

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Table of Contents

 

Chapter 1

: Introduction

Problem Statement………………………………………………………………….3

Background………………………………………………………………………….4

Significance………………………………………………………………………….8

Statement of the Problem in PICOT format………………………………………….9

Conceptual Definitions…………………………………………………………………10

Operational Definitions………………………………………………………………..11

Purpose Statement……………………………………………………………………….11

 

Chapter 2: Literature Review

Introduction…………………………………………………………………………………11

Search Strategies and Yield……………………………………………………………..12

Inclusion and Exclusion Criteria……………………………………………………12

Tool for Critical Appraisal…………………………………………………………12

Literature Review and Critical Apraisail of Evidence……………………………..13

Evaluation and Synthesis of Evidence……………………………………………..27

Recommendation………………………………………………………………………..28

 

References…………………………………………………………………………………30

Appendix A: Synthesis Table………………….…………………………………………..34

Appendix B: Melynk’s Levels of Evidence………………………………………………..40

 

Chapter 1

Problem Statement

The current problem in my area of practice is that there is a lack of utilization of best practices by surgical providers in relation to pain management for patients undergoing shoulder surgery.  Orthopedic surgery is notorious for being painful and is typically managed by utilizing various opioids.  Opioids are known to effectively treat pain; however, they come with many side effects, some of which are extremely serious such as respiratory depression, dependence, and addiction.  This is especially important in the midst of the current opioid epidemic in the United States.  “Crucially, several studies suggest that surgery is associated with an increased risk of long-term opioid use, a phenomenon known as persistent postoperative opioid use” (Kent et al., 2019).  In the United States alone almost 2,000 people die from opioid overdoses each month while approximately two million people have an opioid use disorder (Sharfstein & Olsen, 2019).  Finding a way which has demonstrated to be effective in decreasing opioid usage after surgery is more than just a facility issue, it is a national issue.

Evidence today supports the routine use of multimodal analgesia in the perioperative

period to eliminate the over-reliance on opioids for pain control and to reduce opioid-

related adverse events.  A multimodal analgesic protocol should be surgery specific…with options to tailor to the individual patient.  Elements of this protocol may include opioids, non-opioid systemic analgesics…and local anesthetics administered by infiltration, regional block or the intravenous route. (Schwenk & Mariano, 2018)

In the past three months there were forty-five shoulder surgeries at my institution, and all received opioids in the post anesthesia care unit (PACU) and/or in the same day surgery area prior to discharge.  All of these cases also went home with prescriptions for opioids.  Many surgical institutions have implemented standardized or consistent evidence-based interventions for pain management for specific surgical cases which improve patient outcomes.  Thus, it is important to implement current evidence-based pain management interventions in my clinical area to reduce the number of opioids being administered to patients.

 

Background of the Problem

Shoulder surgery is one of the most common orthopedic surgical cases performed today.  According to Iqbal, Jacobs, Akhtar, Macfarlane & Waseem (2013) the first ever shoulder surgical procedure was performed in the 1800’s.  The first shoulder arthroplasty is said to have been performed in 1893, and the first shoulder arthroscopy was performed in 1931.  In the present day, technology and surgical techniques have allowed for patients to achieve better outcomes, shorter hospital stays, and less pain.  There clearly have been great strides made in the actual surgical procedures to correct anatomical shoulder issues; however, what about the pain management regarding these procedures?

General anesthesia is a routine technique used in many surgical procedures so the patient loses consciousness, is protected from pain during surgery, and has no memory after receiving those anesthetic agents until those agents have worn off.  In the 1800’s, surgery was performed using diethyl ether, and later that century the use of chloroform and nitrous oxide would be become popular as the development of endotracheal intubation was invented.  It was not until 1926 that balanced anesthesia was achieved through the use of multiple anesthetic agents to produce optimal effects of muscle relaxation, unconsciousness and antinociception, and temporarily completely blocking reflex responses. The discovery of Propofol in the late 1970’s led to even greater strides in anesthesia due to its rapid onset, anti-emetic properties and shorter half-life.  (Miller & Pardo, 2011).

Local anesthetic agents are drugs used to infiltrate the surgical site to produce analgesia (pain relief).  In the 1880’s, the first local anesthetic used for a surgical procedure was cocaine, due to its numbing properties on the tongue when consumed.  This led to the creation of multiple drugs, a synthetic form of cocaine being one of them to decrease the unwanted side effects of pure cocaine.  In the 1940’s, the still routinely used, Lidocaine was invented followed by Mepivacaine and Bupivacaine in the late 1950’s which are all also being used (Calatayud & Gonzalez, 2003).  Bupivacaine is commonly used as a local anesthetic in shoulder surgery today but it is a short acting drug and does not provide long term analgesia.

Regional anesthesia, particularly peripheral nerve blocks, for shoulder surgery was not invented until the mid 1900’s.  In 1970, an anesthesiologist named Alon Winnie created the interscalene approach (from the neck) to the brachial plexus providing quality anesthesia to the arm with relatively low risks for patients undergoing shoulder surgery.  This was performed by injecting a local anesthetic around the brachial plexus (Brull, McCartney, Sawyer & Schroeder, 2004).  “The brachial plexus is a network of intertwined nerves that control movement and sensation in the arm and hand…The brachial plexus begins at the neck and crosses the upper chest to the armpit” (American Academy of Orthopaedic Surgeons, 2015).  This provides comfort to the patients by blocking the nerve, causing little to no sensation or movement in the affected extremity.

The effect of the nerve block is temporary and generally lasts eight to twelve hours, up to twenty-four hours.  The nerve block can be administered prior to surgery, in the operating room or in the post-operative period.  The issue with peripheral nerve blocks in the past was it was performed by anatomical landmarking; however, it was not until the 1990’s that ultrasound guidance was utilized by anesthesiologist to perform regional anesthesia.  This made it much safer and decreased complications related to the nerve block procedure.  However, as with any procedure, there are potential risks and complications such as: infection, bleeding, permanent nerve damage, pneumothorax and Horner Syndrome (a disorder related to nerve damage) to name a few.  Some contraindications to a patient receiving an interscalene nerve block is having an infection at the puncture site, coagulopathy disorder, allergy to the local anesthetic, severe respiratory conditions, and pre-existing phrenic nerve damage.  The interscalene nerve block has been considered the gold standard for patients receiving shoulder surgery for many years although new evidence is showing some promising new options (Wang & Zhang, 2017).

It was not until the 1960’s that opioids such as Meperidine (Demerol) and Morphine were additionally administered to treat surgical pain during and/or after surgery (Miller & Pardo, 2011).  These drugs are effective for pain control but come with many side effects such as respiratory depression, constipation, sedation, addiction, and nausea/vomiting.  Opioids are still a large part of shoulder surgical pain management, especially in the post-operative period.  However, there is a growing list of new opioids (such as Percocet, Dilaudid, Fentanyl, and Tramadol) that are utilized by the surgical teams.  For patients who remain in the hospital overnight after surgery, patient controlled analgesia (PCA), is commonly used.  PCA allows the patient to self-administer intravenous pain medication (usually dilaudid, morphine or fentanyl) to themselves by a machine with  prescribed settings and programmed by a licensed provider. Due to the high incidence of adverse drug reactions and the current opioid epidemic in the United States, many surgical team members have tried to utilize techniques that decrease opioid use throughout the surgical experience.

In 2010, a drug that can be considered a pioneer in the quest of decreasing opioid usage in the surgical populations is intravenous (IV) Tylenol (Ofirmev).  “[Ofirmev] has both rapid and effective analgesic properties and is considered to be safe and well tolerated…studies have shown several benefits of using [Ofirmev] perioperatively, including a reduction in opiate consumption, improved analgesia, and reduced postoperative nausea and vomiting” (O’Neal, 2013).  Ofirmev grew in popularity as it proved itself to be very effective in pain management of surgical patients which led to the next phase of pain management called multimodal analgesia (MMA).  MMA has gained attention over the past couple years and often includes Ofirmev and/or oral Tylenol as part of the pain management plan.  According to Elkassabany et al. (2019),

Multimodal pain management refers to the usage of multiple medications to

synergistically enhances analgesia via a variety of mechanisms.  Multimodal analgesia

has been shown to improve postoperative pain control with fewer side effects, thereby

facilitating patient recovery…Specifically within the context of shoulder surgery,

multimodal analgesia has been shown to improve pain scores and decrease opioid

requirements.

Despite a great deal of research on new techniques and drugs, many surgical teams are still in the motion of doing what they are comfortable doing and what they think works.  For instance, the interscalene block is currently considered the gold standard for pain management of shoulder surgeries; however, research has shown that there may be other ways to manage pain as effective or better than an interscalene nerve block.  Liposomal Bupivacaine (Exparel) is a newer local anesthetic that was FDA approved in the United States in 2011.  What makes this drug so unique is that unlike other drugs in its class, this is a long acting local anesthetic that can produce analgesia for up to 96 hours, possibly longer.  Although the continuous interscalene nerve block is not a new technique, it is starting to get more interest for managing pain in shoulder surgical patient populations.  A catheter is placed which continuously releases a local anesthetic to provide comfort to the patient.   It has prolonged analgesic effects when compared to the single shot interscalene nerve block and through the use of ultrasound guidance to insert the catheter, it is easier and safer to perform.  Another technique which has been FDA approved only since 2018, is the ability to use Exparel as the injected local anesthetic for an interscalene nerve block.  This is the first and only long acting local anesthetic drug approved for use in a nerve block.

 

Significance of the Problem

Appropriate and effective pain management of post-operative pain, especially in orthopedic surgeries such as shoulder surgery, is crucial to the well-being of patients.  Orthopedic surgeries are notorious for being extremely painful and typically treated with prescription opioids for the patient to take during the hospital stay as well as while at home.  Opioids are commonly used because their ease and effectiveness.  “Unfortunately narcotic medications are linked with substantial economic burden of adverse events, including nausea, vomiting, and constipation, resulting in high hospital costs, prolonged hospital stays, and substantial health care resource usage in inpatients and outpatients” (Nicholson, Maltenfort, Getz, Lazarus, Williams & Namdari, 2018).  Excessive opioid use can lead to addiction and/or death when overused.

Many people may not realize that “wound complications may be more common with the use of opioid analgesics as a result of respiratory depression and lower oxygen tension” (Angerame, Ruder, Odum & Hamid, 2017).  Wound complications will also increase costs because it will lead to a longer stay in the hospital requiring additional resources if inpatient, and if it is an outpatient case, the patient will need to seek further evaluations from the surgical team and require additional treatments, as well as possibly be admitted to the hospital for treatment.  Another significant impact of improper pain management is psychological in nature.  Uncontrolled pain can lead to psychological distress, anxiety and poor sleeping behavior which can detrimentally impact one’s physical health.

If pain is poorly managed by the surgical team, despite being bad for the patient remaining in pain, it will decrease patient satisfaction which can negatively affect hospital reimbursement due to poor patient satisfaction scores on the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey.  According to the U.S. Department of Health and human Services (2019), pain related costs in the United States ranges anywhere from 560 to 635 billion dollars annually.  These costs include direct medical expenses (like hospital visits and medication costs) as well as indirect expenses such as work that was missed due to pain.

Suboptimal acute-pain management in surgery patients is accompanied by an array of

negative consequences, including increased morbidity, impaired physical function and

quality of life, slowed recovery, prolonged opioid use during and after hospitalization,

and increased cost of care. In addition, early postoperative pain appears to trigger

persistent pain that may last for months after surgery in a substantial proportion of

patients. To prevent the progression from acute to chronic postoperative pain, more

aggressive analgesic/anesthetic measures are needed to reduce the incidence and intensity

of acute pain during and immediately after surgery (Gan, 2017).

 

Statement of the Problem in PICOT format

The PICOT question for this evidence-based practice project is: In adult patients undergoing shoulder surgery, how does surgical staff utilizing current evidence-based pain management interventions throughout the surgical experience compared to the current practice of administering intravenous Tylenol (Ofirmev) affect post-operative numeric pain scores and opioid consumption within three months of intervention implementation.

(P) all surgical staff managing pain in adult patients undergoing shoulder surgery

(I) local infiltration of liposomal bupivacaine (as recommended by six of the journal articles), continuous interscalene nerve block (as recommended by two of the journal articles) and an interscalene nerve block with liposomal bupivacaine (as recommended by two of the journal articles) challenging the current gold standard for shoulder surgery pain management which is a single injection interscalene nerve block with a non-liposomal local anesthetic

(C) compared to pain management with the administration of Ofirmev

(O) increase in all surgical staff implementing current evidence-based pain management interventions producing satisfying pain scores measured by retrospective chart review

(T) over the course of three months from when intervention implementation takes place

 

Conceptual Definitions

Shoulder surgery: According to the American Academy of Orthopaedic Surgeons (2009), shoulder surgery is either open or arthroscopic surgical repair of the shoulder.  Arthroscopic is a less invasive technique whereas open is a more invasive technique.

Numeric pain score: “an 11-point scale with scores from 0 to 10 and anchors of 0 = no pain and 10 = worst possible pain” (Michener, Snyder & Leggin, 2011).

Pain Management: an “interdisciplinary collaboration in order to reduce patient suffering and improve the quality of their lives (Goforth et al., 2013)” (Alsaraireh & Eshah, 2019).

 

Operational Definitions

Shoulder surgery: any invasive surgical intervention used to correct an anatomical issue regarding one or both shoulders

Numeric pain score: a patient self-reported numeric value characterizing the intensity level of discomfort on a scale of zero to ten, zero being no pain and ten being the worst pain

Pain management: Intervention used to treat unpleasant stimuli in the shoulder due to surgical intervention

 

Purpose Statement

The purpose of this evidence-based practice project is to make a recommendation to all surgical staff to utilize current evidence-based methods to control pain throughout the surgical experience via local infiltration of liposomal bupivacaine, continuous interscalene nerve block, and an interscalene nerve block using liposomal bupivacaine, as recommended by a current literature review, in adult patients undergoing shoulder surgery in the hospital setting that achieve lower numeric pain scores while decreasing opioid consumption in the post-operative period.

CHAPTER 2

Introduction

The purpose of this evidence-based practice project is to make a recommendation to all surgical staff to utilize current evidence-based methods to control pain throughout the surgical experience. These methods include local infiltration of liposomal bupivacaine, continuous interscalene nerve block, and an interscalene nerve block using liposomal bupivacaine, as recommended by a current literature review, in adult patients undergoing shoulder surgery in the hospital setting.  These methods achieve lower numeric pain scores while decreasing opioid consumption in the post-operative period.

Search Strategies and Yield

A significantly lengthy search was conducted to obtain relevant and current peer-reviewed articles.  The following databases were used to conduct a literature search via Fairleigh Dickinson University’s online database: ScienceDirect, Medline, and Google Scholar.  The following key words were used while conducting the search: “shoulder surgery” and “pain management.”  The search articles were further narrowed down by limiting the publishing year to 2016-2019 in effort to keep the literature and its evidence as current as possible.  ScienceDirect had 6,390 articles, Medline had 14 articles, and Google Scholar produced 44,300 articles.  In order to narrow down the literature search, abstracts, methods, and results of articles were reviewed in order to determine if it was truly relevant to the purpose of this paper.

Inclusion and Exclusion Criteria

The inclusion criteria for the article search for this paper was adult patients (eighteen years old and older) receiving unilateral shoulder surgery on an inpatient or outpatient basis.  Exclusion criteria included patients undergoing multiple surgical procedures or surgery on both shoulders.

 

Tool for Critical Appraisal

Potential articles then underwent a rapid critical appraisal through the guidelines described by Melnyk & Fineout-Overholt (2015) to ensure the article is valid and credible.  Each article was also rated based on the hierarchy of the level of evidence as described by Melnyk & Fineout-Overholt (2015) (Appendix B). All ten articles used in this paper were either levels I, II or IV.  Level I evidence is considered being the strongest type of evidence and level VII being the least.

Literature Review and Critical Apraisail of Evidence

The article by Patel et al. (2019) titled “Brachial Plexus Block with Liposomal Bupivacaine for Shoulder Surgery Improves Analgesia and Reduces Opioid Consumption: Results from a Multicenter, Randomized Double-Blind Controlled Trial” is a quantitative, random control trial study with level II evidence.  The purpose of this study was to determine the effectiveness of managing pain for shoulder surgical patients by receiving a single-injection interscalene nerve block with liposomal bupivacaine as opposed to the standard anesthetics used in a nerve block.  This article brings to light of the recent Food and Drug Administration (FDA) approval of liposomal bupivacaine (exparel) which may be valuable due to its significantly longer half-life compared to the other local anesthetics that are currently approved.

This was a double-blind randomized control trial that used randomization codes via a centralized randomization system.  The patients and those conducting assessments were blinded; however, the personnel who prepared and administered the drugs were not.  There were 155 total participants in which all completed the study.  Of those participants, 69 were to receive a treatment with 133 mg of liposomal bupivacaine, 15 were to receive a treatment of 266 mg of liposomal bupivacaine, and a control group of 71 patients would receive a saliene placebo.  This article categorized the assessments into three groups: efficacy, safety, and pharmacokinetic.  The data for these categories was all collected for a sufficient amount of time for what they measure.  The efficacy assessment focused on self-reported pain scores of the patients post-operatively.  These scores were collected frequently beginning prior to the administration of the drug continuing for 72 hours post-operatively.  There was also an Overall Benefit of Analgesia Score (OBAS) which measured how satisfied patients were with their pain management treatment.  These scores were assessed at 24 hours, 72 hours and then ten days post-operatively.  Unscheduled visits and phone calls were also recorded until ten days post-operatively.

As for the safety assessment, adverse events were documented for up until 29 days after surgery.  Neurological assessments were performed more frequently for the first 72 hours after surgery, then again on post-operative days five and ten.  Similarly, sensory and motor function assessments took place more frequently for the first 72 hours, then again on days five, ten, and 29 after surgery.  As for the pharmacokinetic assessment, venous blood samples were taken prior to treatment, then upon arrival to the post anesthesia care unit, and then randomly assigned at a certain hour (up to 120 hours after surgery) or until discharge.  Many of the instruments used in this study, such as the VAS, are self-reported by the patient.  All participants answered the same questions using the same scales.  All opioids that were consumed by the patients after surgery were converted into morphine equivalents using the same conversion table.

The results of the study conducted by Patel et al. (2019) concluded that a brachial plexus block with liposomal bupivacaine (LB) had significantly lower pain scores.  LB was associated with significantly reduced opioid consumption post-operatively (P < 0.0001) and significantly prolonged median time to first opioid rescue dose (P < 0.0001) through 48 hours in comparison to the placebo group.  LB treated patient were nine times more likely to be opioid-free through 48 hours (13% vs 1%, risk ratio [RR] = 9.26, 95% confidence interval [CI] = 1.20-71.17).  VAS pain intensity scores were also significantly lower in the LB group at each time interval (all P < 0.05) and at each interval assessed over 72 hours (all P < 0.01).  LB patients were significantly more likely to be opioid free through 24 hours (23.2% vs 1.4%, RR=16.5, 95% CI = 2.2-120.8), with 5.8% remaining opioid free through 72 hours (RR=4.1, CI= 0.5-35.9).  Patient satisfaction with analgesia was also significantly higher with the LB group at each time interval (all P < 0.01).  LB 133 mg showed a similar pharmacokinetic profile as LB 266 mg with an early peak of 115 ng/mL at six hours and an absolute C max of 209 ng/mL at 48 hours.

The obvious benefit demonstrated by this study is that individuals who received an interscalene neve block with liposomal bupivacaine as part of their pain management for shoulder surgery have less pain for a longer period of time when compared to a placebo.  The most common risks reported, although documented as mild to moderate, were: nausea, headache, constipation, dysgeusia, pyrexia and hypoesthesia.  Although not mentioned in the article, another risk is from the interscalene block itself.  The nerve block is performed by an anesthesiologist so their training and skills level has some effect on outcomes.  This particular nerve block, although uncommon, can cause damage to the phrenic nerve.  This is a feasible treatment in any surgical setting that performs shoulder surgery with properly trained, educated, and licensed personnel.

LB 133 mg as a single-injection BPB added to a standardized pain management protocol

was associated with significantly improved analgesia and reduced opioid consumption

through 72 hours after shoulder surgery compared with a standardized protocol alone,

while demonstrating a similar safety profile.  Importantly, patients who received LB 133

mg were nine times more likely to be opioid-free at 48 hours post surgery (Patel et al.,

2019, p. 25).

In the midst of an opioid epidemic, that study brings some promise into the pain management of not only shoulder surgical patients, but potentially all surgical patients.

A prospective observational study, level IV evidence, by Ford, Saini, Szukics, Assiamah, and McMillan (2019), titled “Patient-Reported Outcomes After Arthroscopic Shoulder Surgery with Interscalene Brachial Plexus Nerve Block Using Liposomal Bupivacaine: A Prospective Observational study” was conducted showing positive outcomes for a new type of pain management for shoulder surgery patients.  Pain scores and opioid use were recorded for one week after surgery.  Every patient received general anesthesia and the same standard of care protocol from the testing site; however, there were a variety of types of shoulder surgeries.  In addition, they all received the same prescription of Tylenol and Oxycodone to manage pain as needed post-operatively.  The number of opioids consumed as well as the number of opioids remaining after seven days were recorded via a telephone survey.  Of the 57 patients who participated, 19% did not use a single opioid after surgery, and an average of 2.12 tablets of oxycodone were consumed per person for the entire week.  By day two after surgery, pain scores were an average of 5.1 (standard deviation of 3.1) on the visual analog scale for pain.

Unfortunately, there was no group to compare these patients to during this study.  The interscalene nerve block also depends heavily on the skill of the anesthesiologist who is performing it, which may be a cause in variability in pain scores.  Another potential limitation is the observational nature of the study.  This is a new technique that was fairly recently approved by the Food and Drug Administration, but this study does show a significant potential to decrease the number of opioids required after shoulder surgery.  This study also shows a technique that can decrease the rebound pain associated with an interscalene nerve block using a short-acting anesthetic drug.  “The use of LB for ultrasound-guided, single-shot ISBPNB offers an opioid-minimizing alternative for analgesia after arthroscopic shoulder surgery” (Ford, Saini, Szukics, Assiamah, and McMillan, 2019, p. 3).

An evidence level II prospective randomized control trial article “Liposomal Bupivacaine Versus Interscalene Nerve Block for Pain Control After Shoulder Arthroplasty: A Prospective Randomized Trial” by Okoroha et al. (2016) showed some interesting findings.  This study compared the analgesic effects of local infiltration of liposomal bupivacaine to the single injection interscalene nerve block.  There was a total of 57 adult patients who participated in the study between October 2014-June 2015.  The article did mention that of the 60 patients who qualified for this particular study, three people declined to participate and did not give consent.  Inclusion and exclusion criteria were documented by the authors. Participants were randomly assigned to either the liposomal bupivacaine (LB) group or the interscalene nerve block group (INB); however, the investigators did not blind the physicians involved because the outcomes were self-recorded by the patients.  Thirty-one people were assigned to the INB group and twenty-six to the LB group.  All patients were admitted to the hospital and received the same pain medication orders post-operatively (oxycodone and morphine as needed for pain and Tylenol every eight hours).  For four days after surgery pain scores were recorded through the use of a 10-cm visual analog scale and opioids were converted and documented as intravenous morphine equivalents.  If a patient were discharged prior to the fourth day, a diary was given for the patient to record their pain scores and opioid use.  Once it was collected, a blind observer recorded the patient’s outcomes.

Both groups of patients were appropriate for this study and there was no significant statistical demographic difference between the groups.  The instruments used to collect data were also appropriate for the study and were self-recorded by the patients based on their own experience.  All patients completed the study with only one reported complication of any participant in which a patient in the INB group was readmitted to the hospital due to prolonged phrenic nerve palsy (which is a noted risk of receiving an INB).  Statistical analysis was used to analyze the results of the study in which a P value < .05 was considered significant statistically.  A confirmatory preliminary test was performed to verify the quality of variances prior to using the 2-tailed Student t-test using the mean and standard deviation of each measurement.  Regarding pain scores, the LB group was statistically higher than the INB group from hours 0-8 after surgery (mean [standard deviation] 5.3 [2.2] vs. 2.5 [3.0]; P = 0.001).  However, INB group demonstrated a higher use in narcotic pain medication than the LB group between hours 13-16 after surgery (mean [standard deviation] 1.2 [0.9] vs. 0.6[0.7]; P = 0.01).  After day 0, there were no statistically significant differences between the groups regarding pain scores or consumption of pain medication.  The results of this study showed that both groups ultimately equal in opioid consumption and pain scares, they just trend oppositely of one another making them essentially equal.

There were some limitations that were mentioned by the authors.  Using the VAS is a simple one-dimensional analog where patients tend to report high levels of pain without the ability to recognize subtle changes.  Although the authors stated it was not necessary to blind the physicians, this could be a potential limitation.  Lastly, there was a decline in compliance to using the pain diary as time of the study progressed when the patients were at home. Overall, “[t]his suggests that patients undergoing LIA with LB could potentially benefit with supplementation anesthetic to decrease acute postoperative pain” (Okoroha et al., 2016, p. 6).

Angerame, Ruder, Odum, & Hamid (2017) wrote an article “Pain and Opioid Use After Total Shoulder Arthroplasty with Injectable Liposomal Bupivacaine Versus Interscalene Block.”  This was a level IV evidence retrospective cohort study.  There were 69 participants who qualified for the study who underwent a total shoulder arthroplasty.  The patients assigned themselves to which type of anesthesia they would prefer to receive which lead to 44 people in the interscalene nerve block group and 25 in the liposomal bupivacaine group.  Inclusion and exclusion criteria were provided.  Pain scores, opioid use, and length of hospital stay were measured for both groups. Pain scores and opioid use were recorded for 60 hours after surgery.  Both groups had no statistical difference in opioid usage (p=.71), length of stay (p=.33), or pain scores (p=.73).  The authors did mention that there was a trend in pain scores and opioid use between the two groups.  The liposomal bupivacaine group pain scores and opioid use started higher than trended lower; whereas the INB had the reverse trend.

A limitation of this study is that pain scores were unable to be measured in six-hour intervals showing a greater trend in reported pain scores which may have provided more pertinent information.  This study did show that local infiltration of liposomal bupivacaine does provide similar pain relief and post-operative opioid usage as those who receive the gold standard interscalene nerve block without a patient receiving an additional invasive procedure.  Angerame, Ruder, Odum, & Hamid (2017) also mention that the cost of local infiltration of liposomal bupivacaine ($316.44) is significantly cheaper for patients than receiving an interscalene nerve block ($1,104.50).  “Periarticular injection with liposomal bupivacaine is a useful adjunctive analgesic in lieu of scalene anesthesia for total shoulder arthroplasty” (Angerame, Ruder, Odum, & Hamid, 2017, p. 5).

Wang & Zang (2017) wrote a level I evidence article titled “Liposomal Bupivacaine Versus Interscalene Nerve Block for Pain Control After Total Shoulder Arthroplasty: A Systematic Review and Meta-Analysis” looked at four random control trials involving a total of 510 patients (199 in the Liposomal Bupivacaine group and 311 in the interscalene nerve block group).  Pain scores were measured via the visual analog scale as well as opioid consumption at hour 12, 24, and 48 after surgery.  The following search databases were used to find studies: Embase, PubMed, ScienceDirect, Web of Science, and Cochrane Library.  Inclusion and exclusion criteria were described and there was a total of three reviewers who examine the studies to make a final decision on whether or not the study was acceptable.  Results were ultimately evaluated with the GRADE system.  Stata 11.0 was used for statistical calculations and the random-effects model was utilized to pool data together.

There were no significant differences of pain scores at any of the hours measured: 12 hours (95% CI: -0.164 to 0.710, p= 0.221), 24 hours (95% CI: -.0346 to 0.225, p= 0.678) or 48 hours (95% CI: -0.168 to 0.341, p=0.507).  Regarding opioid consumption at 12, 24 and 48 hours after surgery, there were also no significant differences: 12 hours (95% CI: -0.348 to 0.184, p=0.545), 24 hours (95% CI: -0.136 to 0.228, p=0.618), and 48 hours (95% CI: -0.207 to 0.157, p=0.785).  Being that there were only four RCTs that qualified, the sample size was affected and is considered to be relatively small.  Quality of the outcomes of this meta-analysis were considered moderate.  Analgesic drugs used for the interscalene nerve block varied so it would be ideal if each study used the same drugs and dosages.  Due to the nature of this being a meta-analysis, publication bias is also a limitation.  Despite these limitations, the outcomes of the meta-analysis did show that liposomal bupivacaine is comparable to interscalene nerve block. The authors recommend higher quality RCTs with a bigger sample size will be best to show even stronger results.  “Compared with interscalene nerve block, liposomal bupivacaine had comparative effectiveness on reducing both pain scores and opioid consumption” (Wang & Zang, 2017, p. 14).

Another level I evidence meta-analysis article, “Do Liposomal Bupivacaine Infiltration and Interscalene Nerve Block Provide Similar Pain Relief After Total Shoulder Arthroplasty: A Systematic Review and Meta-Analysis” by Sun, Li, Wang, Zhou, Wu, Fang, and Sun (2018) compares the efficacy of localized infiltration of liposomal bupivacaine to an interscalene nerve block.  The purpose of this study was to compare the efficacy and safety of both analgesic techniques for this patient population through a thorough review and analysis of seven different studies (four RCTs and three retrospective studies) consisting of a total of 707 patients.  Inclusion and exclusion criteria were disclosed in this article as well as the seven selected articles.  Searches through PubMed, Web of Science, EMBASE, and Cochrane Library were utilized.  Based on the statistical analysis used for this meta-analysis (Review Manager), a 95% confidence interval, fixed-effects model, and random-effects model were also utilized, with p<0.05 being considered significant.

Pain scores were analyzed starting at four hours after surgery to the second day post-operatively.  This meta-analysis did show that pain scores were significantly higher at the fourth hour after surgery for the liposomal bupivacaine group (95% CI=0.07, p=0.03) based on three of the seven studies which can be attributed to the mechanism of action of each analgesic technique.  After the four-hour mark, there was no significant difference in pain scores between the two groups.  All seven studies in the meta-analysis had pain scores recorded at the 24-hour mark after surgery with no significant difference (95% CI=-0.48 to 0.13, p=0.26).  There was no significant difference noted the day of surgery based on six studies (95% CI=-0.16 to 0.58, p=0.27).  Four studies reported no difference in opioid consumption on post-operative day one (95% CI=-0.03 to 0.46, p=0.08), and three studies showed no significant difference at post-operative day two (95% CI=-0.86 to 0.86, p=0.01).

There were some important limitations to note regarding this meta-analysis.  There were only seven studies that met the chosen criteria.  The studies selected measured pain scores at different intervals for different lengths of time.  Also, the dosage of drugs administered varied.  As always, with the interscalene nerve block, the skill and knowledge of the anesthesiologist performing the block can affect the pain scores.  An important note from this study is that the interscalene nerve block group provided better analgesia for the first four hours after surgery, and then pain scores and opioid consumption were comparable thereafter.  This was a meta-analysis with a bigger patient population and more studies than the meta-analysis of Wang and Zhang (2017).  Sun, Li, Wang, Zhou, Wu, Fang, and Sun (2018, p. 14) make an important note that, “when considering the equipment and skill requirement for the INB approach, LB infiltration is more recommendable to hospitals without enough qualified personnel or patients with poor economic condition.”

A level I evidence meta-analysis article, “Liposomal Bupivacaine Versus Interscalene Nerve Block for Pain Control After Shoulder Arthroplasty: A Meta-Analysis” was written by Yan, Chen & Ma (2017).  A web search via PubMed, Web of Science and Cochrane Library was conducted and inclusion, as well as exclusion, criteria were provided in all studies, including this meta-analysis.  The analysis consisted of five selected studies with 239 patients receiving local infiltration of liposomal bupivacaine and 334 patients receiving an interscalene nerve block (a total of 573 patients).  Three of the studies were non-RCTs and the other two studies were RCTs.  During a quality assessment, it was noted that three of the five studies had a potentially high risk of bias.  The meta-analysis compared pain scores (through the visual analog scale (VAS)) at hours 4, 8, 12, 24, as well as two weeks after surgery, total morphine consumed, and length of stay (LOS).

Outcomes (VAS, total morphine consumed and LOS) were expressed as weighted mean difference (WMD) with a P value less than 0.05 being significant, and a 95% confidence interval (CI).  Stata software version 12.0, and a random-effects model or fixed effect model were also utilized.  There was no significant difference in pain scores at hours 4 through 12 after surgery.  It was not until hour 24 that a significant difference in reduced pain scores was noted in liposomal bupivacaine group (based on three studies) in comparison to the interscalene nerve block group (WMD= -6.42, 95% CI -10.9, -1.94, p=0.005).  Four of the studies recorded total morphine consumption at 24 hours after surgery which showed no significant difference between the liposomal bupivacaine group and the interscalene nerve block group (WMD=8.6, 95% CI -5.64, 22.84, p=0.236).

Limitations of this meta-analysis include that only two of the five studies were RCTs and all the studies used had a relatively short follow up period after surgery.  The sample sizes were relatively small as well.  However, the meta-analysis does demonstrate that localized liposomal bupivacaine does provide overall similar analgesia with similar opioid use after surgery.  Despite the interscalene nerve block being considered “the gold standard,” localized liposomal bupivacaine is equal without the patient going through an additional procedure which means additional risk factors.  Not all patients are able to receive an interscalene nerve block, so liposomal bupivacaine proves to be an additional effective option for pain management.  “Current meta-analysis indicated that compared with interscalene nerve block, liposomal bupivacaine had comparative effectiveness on reducing acute pain intensity and hospital stay” (Yan, Chen & Ma, 2017, p. 6).

Hannan, Albrecht, Petersen & Srikumaran’s (2016) article “Liposomal Bupivacaine VS Interscalene Nerve Block for Pain Control After Shoulder Arthroplasty: A Retrospective Cohort Analysis” is a level IV evidence retrospective cohort study that compared local infiltration of liposomal bupivacaine (LB) to single-shot interscalene nerve block (ISB) regarding pain scores, opioid usage, and length of stay in the hospital.  Data was collected from nursing and physical therapy charts.  A total of 58 patients were involved in the study, 37 to the LB group and 21 in the ISB group.  All patients involved in the study received the same post-operative pain management medications: intravenous Tylenol, intravenous patient controlled analgesia (PCA), and as-needed oral pain medication.  Specific dosages and drugs were not disclosed for the oral medication and PCA.

A linear mixed model analysis and an initial omnibus test were performed and Stata software version 13 were used to perform calculations in which a P value below 0.05 was considered significant.  This study showed that it was not until 18-24 hours after surgery that a significant difference was discovered in the numeric pain scores in which the LB group reported lower scores than the ISB group (p=0.001), which continued to be significant at 27-36 hours after surgery as well (p=0.029).  Regarding opioid use, no difference was noted on day 1 between the two groups.  Day 2 ISB required more opioids than LB (37mg compared to 25 mg respectively) (p=0.002).

The first and most obvious limitation of this study is the retrospective design.  The sample size was relatively small and there was some data that was missing on some patients.  Although the same surgeon performed all procedures, the types of procedures were variable but the same technique was used for each individual type of surgery.  This study is important because it shows a slight improvement in outcomes for the LB cohort with a decrease in health care related costs.  266mg of LB costs $300 as opposed to $1500 for ISB.  It is interesting to see that although pain scores were similar for the first 18 hours, there was still a significant difference after that point because of the action of the drug which lasts significantly longer.  Overall the authors of the study state that “although we cannot definitively suggest that liposomal bupivacaine is superior to the current gold standard ISNB for pain control after shoulder arthroplasty, our results suggest a relative clinical equipoise between these modalities” (Hannan, Albrecht, Petersen & Srikumaran, 2016, p. 429).

Tariq Malik, Daniel Mass and Stephan Cohn (2016) wrote an article “Postoperative Analgesia in a Prolonged Continuous Interscalene Block Versus Single-Shot Block in Outpatient Arthroscopic Rotator Cuff Repair: A Prospective Randomized Study” which analyzed and compared pain scores, sleep disturbance, number of opioids consumed, patient satisfaction and adverse events between the two types of nerve blocks.  This evidence level II study had a total of 85 participants who were randomly assigned to either the continuous or single-shot nerve block group.  Originally the study had 92 participants, but three were left out of the study due to catheter failure in the continuous group, and the study lost communication with four people from the single-shot group during the follow up period.  Statistical tests were analyzed using Stata statistical software with a P value equal to or less than 0.05 being considered significant.  The same prescription pain medication was prescribed to all patients after surgery consisting of 90 hydrocodone tablets to be taken as needed for pain.  A registered nurse called the patients over a three day period after surgery with a standardized questionnaire.

Although pain scores were equal in the recovery room after surgery between the two groups, they were lower in the continuous group for two days after surgery (p= < 0.001 both days), then pain scores started to even out between the groups but still lower in the continuous group (p=0.044).  This was also reflected in opioid use being that opioids were statistically significantly lower in the continuous group all three days (p<0.0001 for all three days).  Patients were more satisfied with their pain management and had less incidences of disruption in sleep in the continuous group as well (p<0.001 for days one and two, p=0.008 for day three).

A limitation in this study was that the size of the tear in the rotator cuff was not evaluated for the study and due to the nature of this study, they were unable to perform true blinding.  This study shows that it is possible for patients to go home with a continuous nerve block to manage their pain.  This provides another potential alternative for surgical teams to help patients manage their pain while at home.  The patients in this study were instructed to remove the catheters three days after surgery at home.  “In this study, a 3-day continuous interscalene brachial plexus block provided better analgesia than a single-shot block.  Sleep patterns were better, and less opioid was needed after arthroscopic RCR in patients given a continuous plexus block” (Malik, Mass & Cohn, 2016, p. 549).

A level I evidence 2018 meta-analysis article “Should Continuous Rather Than Single-Injection Interscalene Block Be Routinely Offered for Major Shoulder Surgery?  A Meta-Analysis of the Analgesic and Side-Effects Profiles” by Vorobeichik, Brull, Bowry, Laffey, & Abdallah (2018) used fifteen RCTs consisting of 793 patients to analyze the effectiveness of a continuous nerve block in comparison to a single-injection nerve block.  Pain scores and opioid consumption in morphine equivalents were collected over a three day period after surgery.  This study also analyzed patient satisfaction, time to first opioid analgesic request, length of stay in the recovery room, incidence of nausea and vomiting, motor block, and respiratory function.  This analysis used the random-effects model to pool data from the studies.  A 95% confidence interval with a P value below 0.05 was considered statistically significant. Inclusion and exclusion criteria were provided. A risk of bias assessment showed that all studies selected were relatively low overall in risk of bias.

This meta-analysis showed that a continuous interscalene nerve block delivers better analgesia while decreasing opioid use in the post-operative period for three days following surgery.  Pain scores were lower each day measured in the continuous group (day 1 p=0.0009, day 2 p=0.007, day 3 p=0.02).  Opioid consumption was half in the continuous group opposed to the single-injection group (p < 0.0001).  Patients were overall happier with their pain management in the continuous group as well (p<0.00001).  It is important to note that out of the 395 patients in the continuous group, there were no serious complications related to the catheter and only eleven experienced dislodging of the catheter.  Some limitations of this study were that the studies selected for analysis had relatively small sample sizes and there were multiple different shoulder surgeries included between all the studies.  “Contemporary evidence suggests that CISB provides superior analgesia compared with SISB after major shoulder surgery without increasing side-effects or complications” (Vorobeichik, Brull, Bowry, Laffey, & Abdallah, 2018, p. 689).

 

Evaluation and Synthesis of Evidence

All of the studies selected for the purpose of this paper were quantitative studies (Appendix A).  All ten articles showed statistically significant evidence despite the majority of them having relatively small sample sizes.  Six articles showed that liposomal bupivacaine infiltration into the shoulder during surgery provides equivalent pain management and similar or decreasing opioid use in comparison to the current gold standard of care, the interscalene nerve block.  Of the six articles, three of them were meta-analysis which is the top of the hierarchy of level of evidence.  Sun et al. (2018) had the meta-analysis with the highest sample of patients which was 707 among seven different studies.  All the studies show one common theme.  Overall, pain scores and opioid consumption was equivalent to those who receive an interscalene nerve block; however, pain was higher in the first eight hours after surgery for the liposomal bupivacaine patients which then decreased once the drug took effect.  Liposomal bupivacaine has a significantly longer half-life due to the liposomal additives in the drug extending its analgesic effects for up to 96 hours, possibly even more.  The interscalene nerve block works immediately but wears off in twenty-four hours or less causing intense rebound pain.  Local infiltration of liposomal bupivacaine also allows for the patient to maintain their sensory and motor function of their operative arm.

Two articles presented a new technique to manage pain in this patient population.  Both studies showed a decrease in opioid use and pain scores after surgery.  Patel et al. (2019) successfully performed a double-blind randomized control trial using liposomal bupivacaine as the agent for an interscalene nerve block, proving this to be an effective option for pain management.  Ford, Saini, Szukics, Assiamah, & McMillan’s (2019) study also showed a decrease in opioid consumption and pain scores.  In fact, out of all the 57 patients, 570 oxycodone tablets were prescribed with only 120 being consumed which equates to 4.75 tablets consumed for every patient in comparison to the 35 tablets consumed by the typical arthroscopic shoulder repair patient.  Although this method is quite new, it has demonstrated great promise.

The last two articles demonstrated a benefit of using a continuous interscalene nerve block to manage pain whether the patient is admitted to the hospital or discharged home.  Both study articles showed very few complications related to the catheter.  Vorobeichik, Brull, Bowry, Laffey & Abdallah (2018) performed a meta-analysis that showed continuous interscalene nerve blocks provide greater analgesia and decreases opioid use over the course of 72 hours after surgery than the single-shot interscalene nerve block.  This was the largest sample size out of any of the ten articles for this paper with 793 patients and 14 studies.

Recommendation

Pain management is extremely complex and is a skill all in itself, particularly when it comes to managing surgical pain.  Pain related to shoulder surgery produces even more challenges, given that these procedures tend to be more painful.  Opioids are clearly the easiest route for surgical teams to prescribe and have proven to be effective; however, these medications come with detrimental side effects and adverse reactions, as well as leading to addiction and dependence.  The opioid epidemic is causing significant harm to both patients and the healthcare system in many ways.  This is one of the main reasons why surgical teams have implemented multimodal analgesic approaches to managing pain by using a combination of methods to decrease pain without any opioids or limiting their use.

Based on the ten articles in this paper, there are three evidence-based practices that can be recommended to surgical teams to incorporate in their pain management regimens for their patients.  These three methods have proven to be clinically safe for patients while producing positive clinical outcomes by decreasing pain and opioid usage in the post-operative period after shoulder surgery.  These methods are also cheaper for the patients compared to the current gold standard interscalene nerve block, as mentioned in several articles.  Another benefit of utilizing these recommendations in pain management is that it provides more options for patients who do not qualify for certain methods.  For instance, if someone has severe pulmonary disease or refuses an interscalene nerve block, then local infiltration of liposomal bupivacaine would be an excellent substitute.  Pain management is something that should be discussed with the patient prior to surgery to evaluate their preferences as well as what clinicians recommend.  Each patient is different and it is beneficial to everyone involved to be adequately informed with multiple options.

All three of these evidence-based recommendations, as per these ten peer reviewed journal articles, prove to be worthy of a multimodal analgesic approach in managing pain for adult shoulder surgery patients to lower pain scores while decreasing opioid use after surgery.  They also can help the future of pain management in this particular surgical patient population.  Research can be done to see what other medications can be mixed with liposomal bupivacaine.  Perhaps a mixing liposomal bupivacaine with another local anesthetic with a quicker onset of action would provide even better results.  Also, researchers can learn from not only the results of these studies, but the limitations as well.  New studies can be conducted based off of these studies and make attempts to produce even stronger evidence.

References

Alsaraireh, M. & Eshah, N.  (2019).  Factors That Influence the Quality of Pain Management in

Patients with Skin Traction. International Journal of Orthopaedic and Trauma Nursing.

DOI: https://doi.org/10.1016/j.ijotn.2019.100713

American Academy of Orthopaedic Surgeons. (2009).  Treatment: Shoulder Surgery.  Retrieved

from: https://orthoinfo.aaos.org/en/treatment/shoulder-surgery/

American Academy of Orthopaedic Surgeons.  (2015).  Brachial Plexus Injuries.  Retrieved

from: https://orthoinfo.aaos.org/en/diseases–conditions/brachial-plexus-injuries/

Angerame, M., Ruder, J., Odum, S., & Hamid, N.  (2017).  Pain and Opioid Use After Total

Shoulder Arthroplasty with Injectable Liposomal Bupivacaine Versus Interscalene Block,

Orthopedics, 40(5).  DOI: 10.3928/01477447-20170608-01

Brull, R., McCartney C., Sawyer, R., & Schroeder, H.  (2004).  The Indications and Applications

of Interscalene Brachial Plexus Block for Surgery About the Shoulder, Acute Pain, 6, 67-

77. DOI: https://doi.org/10.1016/j.acpain.2004.04.002

Calatayud, J & Gonzalez, A.  (2003).  History of the Development and Evolution of Local

Anesthesia Since the Coca Leaf, Anesthesiology, 6(98), 1503-1508.  Retrieved from:

https://anesthesiology.pubs.asahq.org/article.aspx?articleid=1943164

Elkassabany, N., Wang, A., Ochroch, J., Mattera, M., Liu, J., & Kuntz, A.  (2019).  Improved

Quality of Recovery from Ambulatory Shoulder /surgery After Implementation of a

Multimodal Perioperative Pain Management Protocol, Pain Medicine, 20(5), DOI:

10.1093/pm/pny152

Ford, E., Saini, S., Szukics, P., Assiamah, A., & McMillan, S.  (2019).  Patient-Reported

Outcomes After Arthroscopic Shoulder Surgery with Interscalene Brachial Plexus Nerve

Block Using Liposomal Bupivacaine: A Prospective Observational study, Surgical

Technology International, 35.  Retrieved from:

https://pdfs.semanticscholar.org/4544/0a841a2c377f9714f55b472669b83f0bde1a.pdf?_g

a=2.50954479.754031884.1573331734-831168606.1573331734

Gan, T.  (2017).  Poorly Controlled Postoperative Pain: Prevalence, Consequences, and

Prevention, Journal of Pain Research, 10, 2287-2298.  DOI: 10.2147/JPR.S144066

Hanna, C., Albrecht, M., Petersen, S., & Srikumaran, U.  (2016).  Liposomal Bupivacaine VS

Interscalene Nerve Block for Pain Control After Shoulder Arthroplasty: A Retrospective

Cohort Analysis, The American Journal of Orthopedics, 45(7), 424-430.  Retrieved

from: https://mdedge-files-live.s3.us-east-2.amazonaws.com/files/s3fs-

public/ajo045110424.PDF

Iqbal, S., Jacobs, U., Akhtar, A., Macfarlane, R.J., & Waseem, M.  (2013)  A History of

Shoulder Surgery, The Open Orthopaedics Journal, 7, 305-309.  DOI:

10.2174/1874325001307010305

Kent, M., Hurley, R., Oderda, G., Gordon, D., Sun, E., Mythen, M.,…Mcevoy, M. (2019).

“American Society for Enhanced Recovery and Perioperative Quality Initiative-4 Joint

Consensus Statement on Persistent Postoperative Opioid Use: Definition, Incidence, Risk

Factors, and Health Care Systems Initiatives.  Anesthesia and Analgesia, 129(2), 543-

552. DOI: 10.1213/ANE. 0000000000003941

Malik, T., Mass, D., & Cohn, S.  (2016).  Postoperative Analgesia in a Prolonged Continuous

Interscalene Block Versus Single-Shot Block in Outpatient Arthroscopic Rotator Cuff

Repair: A Prospective Randomized Study, The Journal of Arthroscopic and Related

Surgery, 32(8), 1544-1550.  DOI: 10.1016/j.artho.2016.01.044

Melnyk, B. & Fineout-Overholt, E.  (2015).  Evidence-Based Practice in Nursing & Healthcare:

A Guide to Best Practice (3^RD ed.).  Philadelphia, PA: Wolters Kluwer Health

Michener, L., Snyder, A., & Leggin, G.  (2011).  Responsiveness of the Numeric Pain Rating

Scale in Patients With Shoulder Pain and the Effect of Surgical Status. Journal of Sports

rehabilitation, 20, 115-128.  Retrieved from:

https://www.researchgate.net/profile/Lori_Michener/publication/50409395_Responsiven

ess_of_the_Numeric_Pain_Rating_Scale_in_Patients_with_Shoulder_Pain_and_the_Effe

ct_of_Surgical_Status/links/0c960529f64b061d1c000000/Responsiveness-of-the-

Numeric-Pain-Rating-Scale-in-Patients-with-Shoulder-Pain-and-the-Effect-of-Surgical-

Status.pdf

Miller, R. & Pardo, M.  (2011).  Basics of Anesthesia (6^th ed.).  Philadelphia, PA: Elsevier

Saunders

Nicholson, T., Maltenfort, M., Getz, C., Lazarus, M., Williams, G., & Namdari, S.  (2018).

Multimodal Pain Management Protocol Versus Patient Controlled Narcotic Analgesia for

Postoperative Pain Control After Shoulder Arthroplasty, The Archives of Bone and joint

Surgery, 6(3), 196-202.  Retrieved from:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5990720/

Okoroha, K., Lynch, J., Keller, R., Korona, J., Amato, C., Rill, B., Kolowich, P., & Muh, S.

(2016).  Liposomal Bupivacaine Versus Interscalene Nerve Block for Pain Control After

Shoulder Arthroplasty: A Prospective Randomized Trial, Journal of Shoulder and Elbow

 Surgery, 25(11), 1742-1748.  DOI: https://doi.org/10.1016/j.jse.2016.05.007

O’Neal, J.  (2013).  The Utility of Intravenous Acetaminophen in the Perioperative Period, Front

Public Health, 1(25).  DOI: 10.3389/fpubh.2013.00025

Patel, M., Gadsen, J., Nedelijkovic, S., Bao, X., Zeballos, J., Yu, V., Ayad, S., & Bendtsen, T.

(2019).  Brachial Plexus Block with Liposomal Bupivacaine for Shoulder Surgery

Improves Analgesia and Reduces Opioid Consumption: Results from a Multicenter,

Randomized, Double-Blind, Controlled Trial, Pain Medicine.  DOI:

10.1093/pm/pnz103

Schwenk, E. & Mariano, E.  (2018).  Designing Ideal Perioperative Pain Management Plan Starts

With Multimodal Analgesia.  Korean Journal of Anesthesiology, 71(5), 345-352.  DOI:

10.4097/kja.d.18.00217

Sharfstein, J. & Olsen, Y. (2019).  Making Amends for the Opioid Epidemic.  JAMA, 321(15),

 

1446-1447. DOI: http://dx.doi.org.libaccess.fdu.edu/10.1001/jama.2019.3505

 

Sun, H., Li, S., Wang, K., Zhou, J., Wu, G., Fang, S. & Sun, X.  (2018).  Do Liposomal

Bupivacaine Infiltration and Interscalene Nerve Block Provide Similar Pain Relief After

Total Shoulder Arthroplasty: A Systematic Review and Meta-Analysis, Journal of Pain

Research, 11, 1889-1900.  DOI: 10.2147/JPR.S177716

Unites States Department of Health and Human Services.  (2019).  Pain Management Best

Practices Inter-Agency Task Force Report: Updates, Gaps, Inconsistencies, and

Recommendations.  Retrieved from: https://www.hhs.gov/sites/default/files/pmtf-final-

report-2019-05-23.pdf

Vorobeichik, L., Brull, R., Bowry, R., Laffey, J., & Abdallah, F.  (2018).  Should Continuous

Rather Than Single-Injection Interscalene Block Be Routinely Offered for Major

Shoulder Surgery?  A Meta-Analysis of the Analgesic and Side-Effects Profiles, British

Journal of Anaesthesia, 120(4), 679-692.  DOI: 10.1016/j.bja.2017.11.104

Wang, K. & Zhang, H.  (2017).  Liposomal Bupivacaine Versus Interscalene Nerve Block for

Pain Control After Total Shoulder Arthroplasty: A Systematic Review and Meta-

Analysis, International Journal of Surgery, 46, 61-70.  DOI:

http://doi.org/10.1016/j.ijsu.2017.08.569

Yan, Z., Chen, Z., & Ma, C.  (2017).  Liposomal Bupivacaine Versus Interscalene Nerve

Block for Pain Control After Shoulder Arthroplasty: A Meta-Analysis, Medicine,

96(27).  DOI: 10.1097/MD000000000000722

 

 

 

Appendix A

Synthesis table & legend:

Legend LB= liposomal bupivacaine, INB= interscalene nerve block, SINB= single-shot interscalene nerve block, CINB= Continuous interscalene nerve block, LOS= length of stay, RCT= randomized control trial, TSA= total shoulder arthroplasty

 

STUDY	STUDY DESIGN	LEVEL OF EVIDENCE	SAMPLE SIZE	PURPOSE	RESULTS/ OUTCOMES
Patel et al. (2019)	RCT	II	155 total; LB 133mg, N= 69 LB 266mg, N= 15 Placebo, N= 71	Evaluate efficacy, safety and pharmacokinetics of single-injection liposomal bupivacaine (133mg and 266mg)	LB showed significantly decrease opioid use (p < 0.0001) and lower pain scores (p < 0.05) compared to placebo group over 72 hours; 5.8% opioid free for 72 hours (RR=4.1, CI= 0.5-35.9); LB 133mg = LB 266mg in pharmacokinetic profiles
Ford, Saini, Szukics, Assiamah, and McMillan (2019)	Prospective Observational Study	IV	N = 57	Determine efficacy of LB to INB to manage pain after shoulder surgery	19% did not use a single opioid after surgery; average opioids consumed was 2.12 tabs per person over 1 week; average pain score on day 2 was 5.1 (SD of 3.1)
Okoroha et al. (2016)	Prospective RCT	II	Total, n=57 INB, n=31 LB, n=25	Perform a prospective RCT trial of INB vs LB for pain control in shoulder arthroplasty	First 8 hours after surgery LB pain scores were greater than INB (p=0.001); after 13 hours INB group used more opioids (p=0.01); after day 0, no significant differences in pain or opioids
Angerame, Ruder, Odum, & Hamid (2017)	Retrospective Cohort	IV	Total, n=69 INB, n=44 LB, n=25	Compared efficacy of LB vs INB in total shoulder arthroplasty patients for 60 hours after surgery	There was no significant difference in opioid consumption (p=0.71), LOS (p=0.33), pain scores (p=0.73); LB group pain scores trended better than INB
Wang & Zang (2017)	Meta-Analysis	I	4 RCTs Total, n=510 INB, n=311 LB, n=199	Compared efficacy of LB vs INB in total shoulder arthroplasty in a systematic search	Pain scores between both groups were equal at 12 hours after surgery (p=0.221), 24 hours (p=0.678), and 48 hours (p=0.507); opioid use was also equal between the groups at 12 hours (p=0.545), 24 hours (p=0.618), 48 hours (p=0.785)
Sun, Li, Wang, Zhou, Wu, Fang, and Sun (2018)	Meta-Analysis	I	7 studies total (4 RCTs and 3 retrospective studies); Total, n= 707	Compare efficacy and safety of local LB vs INB	3 of 7 studies showed higher pain scores in LB group 4 hours after surgery (95% CI=0.07, p=0.03), then no significant difference thereafter; At 24 hours 7 of 7 studies showed no difference (95% CI=0.48 to 0.13, p=0.26); opioid use day 0 6 of 7 studies showed no difference (95% CI= -0.16 to 0.58, p=0.27); Day 1 opioid use 4 of 7 studies showed no difference (95% CI= -0.03 to 0.46, p=0.08); 3 of 7 studies no difference day 2 (95% CI= -0.86 to 0.86, p=0.01)
Yan, Chen & Ma (2017)	Meta-Analysis	I	5 studies (2 RCTs, 3 non-RCTs) Total, n= 573 INB, n= 239 LB, n=334	Determine efficacy of LB to INB to control pain in TSA patients	No difference in pain scores until 24 hours after surgery in which LB group was lower than INB in 3 of 5 studies (95% CI= -10.9, -1.94, p=0.005); 4 of 5 studies showed no difference in opioid use 24 hours after surgery (95% CI= -5.64, 22.84, p=0.236)
Hannan, Albrecht, Petersen & Srikumaran’s (2016)	Retrospective Cohort	IV	Total, n=58 INB, n=21 LB, n=37	Compare analgesic effects of LB to INB after shoulder arthroplasty	LB had lower pain scores at 18-24 hours after surgery (p=0.001) and again at 27-36 hours (p=0.029); opioid use day 1 had no difference but day 2 INB required more opioids than LB (p=0.002)
Malik, Mass & Cohn (2016)	Prospective RCT	II	Total, n=85 CINB, n=43 SINB, n=42	Compare analgesic effects of CINB to SINB for 3 days after surgery	CINB had lower pain scores for first 2 days after surgery (p<0.001 both days) and day 3 (p<0.044); opioid use all 3 days was lower in CINB group (p<0.0001 for all 3 days)
Vorobeichik, Brull, Bowry, Laffey, & Abdallah (2018)	Meta-Analysis	I	15 RCTs Total, n=793 CINB, n=395 SINB, n=398	Evaluate analgesic effects of CINB to SINB after major shoulder surgery	CINB group had lower pain scores days 1, 2, and 3 after surgery (p=0.0009, p=0.007, p=0.02, respectively); opioid consumption was half the amount in the CINB group than the SINB (p<0.00001)

Appendix B

Source: Melnyk & Fineout-Overholt (2015), pg. 11