Post-operative Exparel Study Following Rotator Cuff Repair

NCT ID: NCT04047745

Last Updated: 2019-08-07

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-30

Study Completion Date

2021-09-30

Brief Summary

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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

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Conditions

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Rotator Cuff Tears

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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liposomal bupivacaine

Group Type ACTIVE_COMPARATOR

Liposomal bupivacaine

Intervention Type DRUG

interscalene nerve block administered before surgery using 133 mg liposomal bupivacaine with 10mL 0.5% ropivacaine

ropivacaine

Group Type ACTIVE_COMPARATOR

Ropivacaine injection

Intervention Type DRUG

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

Intervention Type DRUG

Ropivacaine injection

interscale nerve block administered before surgery using 30mL 0.5% ropivacaine

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rothman Institute Orthopaedics

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rothman Orthopaedics at Egg Harbor Township

Egg Harbor, New Jersey, United States

Site Status

Countries

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United States

Central Contacts

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Director of Clinical Trials

Role: CONTACT

267-339-7818

Other Identifiers

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2019Tucker

Identifier Type: -

Identifier Source: org_study_id

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