Single Shot Liposomal Bupivicaine in Rotator Cuff Surgery
Completed · Phase 4
Conditions studied: Rotator Cuff Tear, Pain, Postoperative
In brief
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.
Key facts
- Study ID
- NCT03822182
- Run by
- Indiana University
- People needed
- 78
- Starts
- 2018-10-24
- Expected to finish
- 2020-01-22
- Last updated by the study team
- 2020-11-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Age 18 and older
- Primary diagnosis of rotator cuff tear
- Able to provide informed consent
- Is willing and able to accept text messages
You may not qualify if…
- 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
Where it is running
- American Health Network — Avon, Indiana, United States
Full record on ClinicalTrials.gov
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