MedTrace Logo

Liposomal Bupivacaine After Arthroscopic Rotator Cuff Repair

NCT03149887 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2020-01-23

Study results available
· View outcomes & findings →

Summary

Liposomal bupivacaine, a long-acting form of bupivacaine, has been found to be effective for postoperative pain control after total knee, total hip and total shoulder arthroplasty. We are conducting a randomized, controlled trial to evaluate pain control after arthroscopic rotator cuff repair in ambulatory patients, comparing standard care in the control group, with standard care plus the addition of injection of liposomal bupivacaine in the experimental group.

Conditions

  • Rotator Cuff Tear

Interventions

DRUG

Liposomal bupivacaine

Liposomal bupivacaine solution (Exparel) for injection

DRUG

Placebo

Inert solution created to appear as liposomal bupivacaine (Exparel) for injection

Sponsors & Collaborators

  • Pacira Pharmaceuticals, Inc

    collaborator INDUSTRY

  • Steven Orebaugh

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-12-05
Primary Completion
2019-02-26
Completion
2019-03-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT03149887 on ClinicalTrials.gov