Post-operative Exparel Study Following Rotator Cuff Repair

Rothman Institute Orthopaedics

Status: Unknown

Conditions: Rotator Cuff Tears

Treatments: Drug: Ropivacaine injection; Drug: Liposomal bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT04047745

2019Tucker

Details and patient eligibility

About

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.

Enrollment: 132 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

132 participants in 2 patient groups

liposomal bupivacaine

Active Comparator group

Treatment:

Drug: Liposomal bupivacaine

ropivacaine

Active Comparator group

Treatment:

Drug: Ropivacaine injection