Post-operative Exparel Study Following Rotator Cuff Repair
The Use of Liposomal Bupivacaine Interscalene Brachial Plexus Block for Rotator Cuff Surgery: A Randomized, Double Blind, Clinical Trial
1 other identifier
interventional
132
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 5, 2019
CompletedFirst Posted
Study publicly available on registry
August 7, 2019
CompletedStudy Start
First participant enrolled
September 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2021
CompletedAugust 7, 2019
August 1, 2019
2 years
August 5, 2019
August 6, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
opioid consumption
postsurgical opioid consumption
surgery through 48 hours post-op
Study Arms (2)
liposomal bupivacaine
ACTIVE COMPARATORropivacaine
ACTIVE COMPARATORInterventions
interscalene nerve block administered before surgery using 133 mg liposomal bupivacaine with 10mL 0.5% ropivacaine
interscale nerve block administered before surgery using 30mL 0.5% ropivacaine
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rothman Orthopaedics at Egg Harbor Township
Egg Harbor, New Jersey, 08234, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2019
First Posted
August 7, 2019
Study Start
September 1, 2019
Primary Completion
September 1, 2021
Study Completion
September 1, 2021
Last Updated
August 7, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share