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The Effect of EXPAREL® on Postsurgical Pain, and the Use of Narcotics

NCT03290196 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2025-03-30

Study results available
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Summary

Patients undergoing shoulder rotator cuff surgery in an outpatient setting are the focus of this study. The purpose of this study is to determine if the product EXPAREL® can be used as a safe alternative in shoulder surgery to pain pumps, while limiting narcotic use and providing appropriate postoperative pain control.

Conditions

  • Rotator Cuff Tear

Interventions

DRUG

EXPAREL 1.3 % in 20 ML Injection

EXPAREL single shot dose given as an analgesia for arthroscopic rotator cuff repair surgery.

Sponsors & Collaborators

  • Pacira Pharmaceuticals, Inc

    collaborator INDUSTRY

  • Andrews Research & Education Foundation

    lead OTHER

Principal Investigators

  • James R Andrews, MD · Andrews Institute for Orthopaedics & Sports Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
72 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-03
Primary Completion
2016-12-22
Completion
2022-04-07
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03290196 on ClinicalTrials.gov