Single Shot Liposomal Bupivicaine in Rotator Cuff Surgery

• Status: Completed
• Trial end date: 2020-01-22
• Target enrollment: 0
• Participant gender: All

Summary

This document is a protocol for a human research study. This study is to be conducted according to United States standards of Good Clinical Practice in accordance with applicable Federal regulations and institutional research policies and procedures.

Liposomal bupivacaine (LB) has been shown to decrease post-operative pain and narcotic use when administered perioperatively as a local injection during arthroplasty procedures. Studies have also demonstrated that LB used in conjunction with dexamethasone may increase the duration of effectiveness of LB. This study seeks to evaluate if there is a difference in post-operative pain and narcotic use when LB is administered in an interscalene block during outpatient rotator cuff repair surgery. Furthermore, this study aims to determine if the addition of dexamethasone with LB results in a prolonged decrease in post-operative pain and a reduction in narcotic use.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Indiana University
• Treatments: BB 1101; Bupivacaine; Dexamethasone; Dexamethasone acetate

Criteria

Inclusion Criteria:

• Age 18 and older

• Primary diagnosis of rotator cuff tear

• Able to provide informed consent

• Is willing and able to accept text messages

Exclusion Criteria:

• Known allergies to the study medications.

• Known narcotic or alcohol abuse (< 3 months)

• Revision rotator cuff surgery

• Contraindication to regional anesthesia

• Current narcotic regimen or contract with pain management specialist

• Diagnosed with any of the following co-morbidities:

• Pre-existing coagulation disorder