The Effect of Liposomal Bupivacaine Nerve Block (Exparel) in Rotator Cuff Surgery

PHASE4Enrolling by invitationINTERVENTIONAL
Enrollment

160

Participants

Timeline

Start Date

July 11, 2019

Primary Completion Date

June 1, 2024

Study Completion Date

June 1, 2025

Conditions
Rotator Cuff TearsPostoperative PainOpioid Use
Interventions
DRUG

Exparel Injectable Solution

"Patients randomized to this arm will receive an interscalene block with Exparel solution, an extended-release formulation of bupivacaine (10cc liposomal bupivacaine + 15cc bupivacaine), approved for use at the study institution. This will be administered preoperatively on the day of surgery. The anesthesiologist administering the injection will be not be blinded to the mixture of injections (the surgeon and the patient will), which will be designated and randomized prior to administration. They will order and draw up the medication as they have been previously with no change in the standard of care.~After surgery, the patient will be asked to keep a daily log of their pain scores, and the amount of narcotics will be counted by the physician at the first postoperative visit. The block would have been offered to the patient even if they are not part of the study. No additional visits are required. The only difference is the journal with pain score surveys and the pill count."

DRUG

Bupivacaine Injectable Solution

"Patients randomized to this arm will receive a standard interscalene block consisting of 25 cc of bupivacaine alone. This will be administered preoperatively on the day of surgery.~The anesthesiologist administering the injection will not be blinded to the mixture of injections (the surgeon and the patient will), which will be designated and randomized prior to administration. They will order and draw up the medication as they have been previously with no change in the standard of care.~After surgery, the patient will be asked to keep a daily log of their pain scores, and the amount of narcotics will be counted by the physician at the first postoperative visit. The block would have been offered to the patient even if they are not part of the study. No additional visits are required. The only difference is the journal with pain score surveys and the pill count."

Trial Locations (1)

08103

Cooper University Hospital, Camden

All Listed Sponsors
lead

The Cooper Health System

OTHER