Status:
COMPLETED
Single Shot Liposomal Bupivicaine in Rotator Cuff Surgery
Lead Sponsor:
Indiana University
Conditions:
Rotator Cuff Tear
Pain, Postoperative
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 a...
Detailed Description
Outpatient surgery has become the gold standard for arthroscopic rotator cuff repair. Innovations in pain management with regional anesthesia and multimodal techniques have greatly contributed to this...
Eligibility Criteria
Inclusion
- Age 18 and older
- Primary diagnosis of rotator cuff tear
- Able to provide informed consent
- Is willing and able to accept text messages
Exclusion
- 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
Key Trial Info
Start Date :
October 24 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 22 2020
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT03822182
Start Date
October 24 2018
End Date
January 22 2020
Last Update
November 12 2020
Active Locations (1)
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1
American Health Network
Avon, Indiana, United States, 46123