Status:
UNKNOWN
Post-operative Exparel Study Following Rotator Cuff Repair
Lead Sponsor:
Rothman Institute Orthopaedics
Conditions:
Rotator Cuff Tears
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The primary purpose of this study is to determine if the postoperative oral narcotics consumption in patients receiving liposomal bupivacaine (LB) interscalene brachial plexus nerve block (ISBPB) is d...
Eligibility Criteria
Inclusion
- Males and females aged 18 years or older with a full-thickness rotator cuff tear (confirmed on MRI) undergoing arthroscopic rotator cuff repair surgery.
- Anesthesiologists physical status 1, 2, or 3 and normal preoperative motor (Lovett scale: biceps, wrist, thumb) and sensory function.
Exclusion
- Revision shoulder surgery
- History of more than 1 prior surgery performed on the operative shoulder
- Concomitant severe glenohumeral arthritis
- Concomitant adhesive capsulitis
- Worker's compensation claim
- Pregnancy
- History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics
- History of renal or hepatic failure
- Chronic neuromuscular deficit affecting the surgical limb.
- Uncontrolled psychiatric or neurologic disorder
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2021
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT04047745
Start Date
September 1 2019
End Date
September 1 2021
Last Update
August 7 2019
Active Locations (1)
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1
Rothman Orthopaedics at Egg Harbor Township
Egg Harbor, New Jersey, United States, 08234