Post-operative Exparel Study Following Rotator Cuff Repair

Not Applicable

• Conditions: Rotator Cuff Tears
• Interventions: Drug: Liposomal bupivacaine; Drug: Ropivacaine injection

• Registration Number: NCT04047745
• Lead Sponsor: Rothman Institute Orthopaedics

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 different than the narcotics consumption receiving traditional bupivacaine ISBPB for arthroscopic rotator cuff repair analgesia.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-08
• Study First Submitted: 2019-08-05
• Study First Submitted QC: 2019-08-06
• Last Update Submitted: 2019-08-06
• Study First Posted: 2019-08-07
• Last Update Posted: 2019-08-07
• Study Start: 2019-09
• Primary Completion: 2021-09
• Study Completion: 2021-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
liposomal bupivacaine	Liposomal bupivacaine	-
ropivacaine	Ropivacaine injection	-

Primary Outcome Measures

Name	Time	Method
opioid consumption	surgery through 48 hours post-op	postsurgical opioid consumption

Trial Locations

Locations (1)

Rothman Orthopaedics at Egg Harbor Township; 🇺🇸 Egg Harbor Township, New Jersey, United States