Rotator Cuff Tears
Conditions
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.
Interventions
DRUGLiposomal bupivacaine
interscalene nerve block administered before surgery using 133 mg liposomal bupivacaine with 10mL 0.5% ropivacaine
DRUGRopivacaine injection
interscale nerve block administered before surgery using 30mL 0.5% ropivacaine
Sponsors
Rothman Institute Orthopaedics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| opioid consumption | surgery through 48 hours post-op | postsurgical opioid consumption |
Countries
United States
Contacts
Primary ContactDirector of Clinical Trials
Outcome results
None listed