Interscalene Block With and Without Liposomal Bupivacaine in Shoulder Surgery

Study Overview
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Brief Summary
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The purpose of this study is to examine the difference in perioperative pain after shoulder surgery with a standard bupivacaine nerve block compared to liposomal bupivacaine enhanced nerve block alone in TSA and ARCR. Data will be compared using VAS scores and opiate consumption between the two groups. The hypothesis of this study is that an interscalene nerve block with liposomal bupivacaine will decrease both postoperative VAS pain scores and total narcotic consumption when compared to a standard bupivacaine interscalene nerve block alone.

Detailed Description
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Arthroscopic rotator cuff repair (ARCR) and shoulder arthroplasty (TSA) provide excellent clinical outcomes but are often associated with significant postoperative pain, frequently managed with oral opioid medication. Orthopedic surgeons prescribe approximately 32 unused pills per shoulder surgery and are the third largest prescribers of opiates in the USA. It is incumbent upon the orthopedic community to identify postoperative pain management methods which reduce the need for narcotic medication following shoulder procedures as a means to mitigate the impact of orthopedic procedures on this epidemic. The use of intraoperative local and regional anesthesia or field blocks, in conjunction with multimodal pharmacological strategies, is an accepted approach for managing surgical pain and reducing opiate use but requires peer reviewed protocols to gain wider acceptance. Interscalene nerve block with bupivacaine remains a gold standard for peri-operative analgesia, but is associated with significant rebound pain due to the short duration of the local anesthetics. Recent studies have demonstrated that the addition of a liposomal bupivacaine field block may lower pain and enhance patient satisfaction throughout the first postoperative week. Liposomal bupivacaine has recently received FDA approval for ISB, but the data regarding its efficacy in nerve blocks is sparse. The purpose of this pilot study is to determine if liposomal bupivacaine-enhanced interscalene nerve blocks can be used to improve peri-operative pain control methods, limit narcotic use, and provide appropriate postoperative analgesia compared to standard bupivacaine blocks. Primary and secondary outcome measures will be collected as number of opiates taken and self-reported VAS pain scores over a 14 day postoperative period, respectively. The hypothesis of this study is that an interscalene nerve block with liposomal bupivacaine will decrease both postoperative VAS pain scores and total narcotic consumption when compared to a standard bupivacaine interscalene nerve block alone.

Official Title
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Interscalene Block With and Without Liposomal Bupivacaine in Shoulder Surgery

Conditions
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Rotator Cuff Tear, Postoperative Pain

Intervention / Treatment
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* Drug: Liposomal Bupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients over 18 undergoing rotator cuff repair or total shoulder arthroplasty Exclusion Criteria: Pregnant Documented drug of alcohol abuse Active narcotic use prior to surgery Neurological deficit Allergy to amide anesthetics Not cleared by primary care physician Hydrocodone or oxycodone intolerance Enrollment in another clinical trial or past cognitive or mental health status that interferes with study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liposomal Bupivacaine Interscalene Block<br>Liposomal bupivacaine anesthetic will be administered as an interscalene block during rotator cuff repair surgery and total shoulder arthroplasty. | Drug: Liposomal Bupivacaine<br>* Addition of 15mL of liposomal bupivacaine to 15mL of standard nerve block anesthetic solution containing 0.5% bupivacaine and 4mg of decadron<br>* Other names: EXPAREL;|
| No Intervention: Bupivacaine Interscalene Block<br>Bupivacaine anesthetic will be administered as an interscalene block during rotator cuff repair surgery and total shoulder arthroplasty. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opiate Consumption | Total amount of narcotics consumed during the postoperative period, measured in morphine equivalents (OME) | Post-operative days 1-14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS Pain Scores | A standardized measure of subjective pain on a scale of 0 to 10, from zero pain to excruciating pain, respectively | Post operative days 1-14 | 
| Likert Pain Satisfaction Rating | A standardized measure of patient satisfaction with pain management from 1 (very unsatisfied) to 5 (very satisfied) | Post operative days 1-14 |