Efficacy of Interscalene Brachial Plexus Block With Liposomal Bupivacaine for Arthroscopic Shoulder Surgery

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-02-28

Brief Summary

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The purpose of this study is to compare the quality and duration of pain relief after shoulder surgery provided by a single injection of liposomal bupivacaine versus standard bupivacaine when administered as an interscalene brachial plexus block. It is hypothesized that the liposomal bupivacaine formulation will provide more effective pain relief than standard bupivacaine.

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Detailed Description

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Conditions

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Shoulder Pain Rotator Cuff Tear

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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Bupivacaine 0.25%

20 cc of bupivacaine 0.25%

Group Type ACTIVE_COMPARATOR

Liposomal bupivacaine

Intervention Type DRUG

liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc)

Liposomal bupivacaine

liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc)

Group Type EXPERIMENTAL

Bupivacaine 0.25%

Intervention Type DRUG

20 cc of bupivacaine 0.25%

Interventions

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Liposomal bupivacaine

liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc)

Intervention Type DRUG

Bupivacaine 0.25%

20 cc of bupivacaine 0.25%

Intervention Type DRUG

Other Intervention Names

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Exparel Bupivacaine

Eligibility Criteria

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Inclusion Criteria

* English speaking adults (age \>17 years) of American Society of Anesthesiologists (ASA) I-III physical class scheduled for elective arthroscopic shoulder surgery will be eligible to participate regardless of race/ethnicity.

Exclusion Criteria

* Subjects will not be eligible for this trial if they report a history of an allergy to a local anesthetic, baseline neurological deficit, a medical condition that would make it difficult to assess sensory distribution or communicate with the staff, a recent history (\< 3 months) of drug or alcohol abuse, concomitant opioid therapy, or a preexisting coagulation disorder.

Minimum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes