Liposome Bupivacaine Interscalene Total Shoulder
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|ClinicalTrials.gov Identifier: NCT03587636|
Recruitment Status : Recruiting
First Posted : July 16, 2018
Last Update Posted : August 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Acute Pain||Drug: liposome bupivacaine Drug: Bupivacaine||Phase 2|
Liposomal bupivacaine (LB) is a long acting local anesthetic. It is liposome encapsulated bupivacaine which allows for prolonged release of bupivacaine over a 72-hour period. Bupivacaine is a medium acting local anesthetic which provides between 6 and 24 hours of analgesia when used in a peripheral nerve block. Both medications are standard of care for use in interscalene blocks here at the U of MN.
LB has not been adequately studied in peripheral nerve blocks and has yet to be studied for use in interscalene blocks for Total Shoulder Arthroplasty (TSA) patients. It has been studied in Rotator Cuff Repairs (RCR) surgery and showed superior analgesia compared to bupivacaine.
The purpose of the study is to determine if LB plus bupivacaine provides superior pain control compared to bupivacaine alone when injected in an interscalene block for patients undergoing total shoulder arthroplasty surgery.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Prospective Randomized Controlled Trial Comparing Liposomal Bupivacaine to Bupivacaine Interscalene Blocks for Total Shoulder Arthroplasty Surgery; a Pilot Study|
|Actual Study Start Date :||July 17, 2018|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: Liposome bupivacaine interscalene block
10 mL of liposome bupivacaine and 10 mL of 0.5% bupivacaine will be injected at the interscalene brachial plexus under ultrasound guidance
Drug: liposome bupivacaine
interscalene block with liposomal bupivacaine plus bupivacaine
Other Name: bupivacaine
Active Comparator: bupivacaine interscalene block
20 mL of 0.5% bupivacaine will be injected at the interscalene brachial plexus under ultrasound guidance.
interscalene block with bupivacaine
- Total opioid use [ Time Frame: From end of surgery through 72 hours after end of surgery ]total amount of opioid use from after surgery through 72 hours. Opioids normalized to morphine equivalents
- Total maximum pain scores f [ Time Frame: time from end of surgery through 72 hours after end of surgery ]Sum total of maximal pain scores through 72 horus after surgery. Pain scores reported on a numerical rating scale from 0-10. 10 is worse and 0 is best
- Overall benefit of analgesia score [ Time Frame: survey occurring at 72 hours after the end of surgery ]Score on the overall benefit of analgesia rating scale via the overall benefit of analgesia survey taken at the 72 hour mark. higher scores are worse. range 0-28
- Quality of recovery 15 score [ Time Frame: survey occurring at 72 hours after the end of surgery ]Score on the quality of recovery 15 survey taken at the 72 hour mark. higher score is better. score range 0-150
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): NCT03587636
|Contact: James Flaherty, MDemail@example.com|
|Contact: Melissa Cohen||Cohen045@umn.edu|
|United States, Minnesota|
|University of Minnesota||Recruiting|
|Minneapolis, Minnesota, United States, 55455|
|Contact: Melissa Cohen 612-625-7116|
|Principal Investigator:||James Flaherty, MD||University of Minnesota|