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

S

St. Luke's-Roosevelt Hospital Center

Status and phase

Completed
Phase 4

Conditions

Rotator Cuff Tear
Shoulder Pain

Treatments

Drug: Liposomal bupivacaine
Drug: Bupivacaine 0.25%

Study type

Interventional

Funder types

Other

Identifiers

NCT01977352
13-0064

Details and patient eligibility

About

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.

Enrollment

42 patients

Sex

All

Ages

17+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

42 participants in 2 patient groups

Bupivacaine 0.25%
Active Comparator group
Description:
20 cc of bupivacaine 0.25%
Treatment:
Drug: Liposomal bupivacaine
Liposomal bupivacaine
Experimental group
Description:
liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc)
Treatment:
Drug: Bupivacaine 0.25%

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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