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

Summary

The goal of this clinical trial is to investigate if there is a difference in pain after an arthroscopic rotator cuff surgery when a nerve block is performed with liposomal bupivacaine versus the standard treatment of bupivacaine alone.

The main question aims to answer if patients who receive liposomal bupivacaine have better pain control and lower postoperative opioid consumption compared to bupivacaine alone.

Participants be randomized to either the control group to receive a standard interscalene block with bupivacaine (25 cc of bupivacaine) or the experimental group to receive similar dosing of liposomal bupivacaine mixed with bupivacaine (10cc liposomal bupivacaine + 15cc bupivacaine). Data will be prospectively collected and the data from the experimental group will be compared to the control group at the completion of the study period.

Conditions

• Rotator Cuff Tears
• Postoperative Pain
• Opioid 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.

Sponsors & Collaborators

• The Cooper Health System

  lead OTHER

Principal Investigators

• Catherine J Fedorka, MD · The Cooper Health System

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-07-11

Primary Completion

2024-06-01

Completion

2025-06-01

FDA Drug

Yes

Countries

• United States

Study Locations