Interscalene Block With and Without Liposomal Bupivacaine in Shoulder Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03728946|
Recruitment Status : Completed
First Posted : November 2, 2018
Last Update Posted : March 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|Rotator Cuff Tear Postoperative Pain||Drug: Liposomal Bupivacaine||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||Interscalene Block With and Without Liposomal Bupivacaine in Shoulder Surgery|
|Actual Study Start Date :||November 21, 2018|
|Actual Primary Completion Date :||March 1, 2020|
|Actual Study Completion Date :||March 1, 2020|
Experimental: Liposomal Bupivacaine Interscalene Block
Liposomal bupivacaine anesthetic will be administered as an interscalene block during rotator cuff repair surgery and total shoulder arthroplasty.
Drug: Liposomal Bupivacaine
Addition of 15mL of liposomal bupivacaine to 15mL of standard nerve block anesthetic solution containing 0.5% bupivacaine and 4mg of decadron
Other Name: EXPAREL
No Intervention: Bupivacaine Interscalene Block
Bupivacaine anesthetic will be administered as an interscalene block during rotator cuff repair surgery and total shoulder arthroplasty.
- Opiate Consumption [ Time Frame: Post-operative days 1-14 ]Total amount of narcotics consumed during the postoperative period, measured in morphine equivalents (OME)
- VAS Pain Scores [ Time Frame: Post operative days 1-14 ]A standardized measure of subjective pain on a scale of 0 to 10, from zero pain to excruciating pain, respectively
- Likert Pain Satisfaction Rating [ Time Frame: Post operative days 1-14 ]A standardized measure of patient satisfaction with pain management from 1 (very unsatisfied) to 5 (very satisfied)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03728946
|United States, Connecticut|
|Greenwich, Connecticut, United States, 06830|
|Orthopaedic & Neurosurgery Specialists|
|Greenwich, Connecticut, United States, 06831|
|Stamford Ambulatory Surgical Center|
|Stamford, Connecticut, United States, 06902|
|United States, Florida|
|Atlantis, Florida, United States, 06831|
|Palm Beach Gardens, Florida, United States, 33410|
|United States, Oregon|
|Southern Oregon Orthopedics, Inc.|
|Medford, Oregon, United States, 97504|