Post-operative Exparel Study Following Rotator Cuff Repair
NCT ID: NCT04047745
Last Updated: 2019-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
132 participants
INTERVENTIONAL
2019-09-30
2021-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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liposomal bupivacaine
Liposomal bupivacaine
interscalene nerve block administered before surgery using 133 mg liposomal bupivacaine with 10mL 0.5% ropivacaine
ropivacaine
Ropivacaine injection
interscale nerve block administered before surgery using 30mL 0.5% ropivacaine
Interventions
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Liposomal bupivacaine
interscalene nerve block administered before surgery using 133 mg liposomal bupivacaine with 10mL 0.5% ropivacaine
Ropivacaine injection
interscale nerve block administered before surgery using 30mL 0.5% ropivacaine
Eligibility Criteria
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Inclusion Criteria
* Anesthesiologists physical status 1, 2, or 3 and normal preoperative motor (Lovett scale: biceps, wrist, thumb) and sensory function.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Rothman Institute Orthopaedics
OTHER
Responsible Party
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Locations
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Rothman Orthopaedics at Egg Harbor Township
Egg Harbor, New Jersey, United States
Countries
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Central Contacts
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Other Identifiers
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2019Tucker
Identifier Type: -
Identifier Source: org_study_id
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