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Intraoperative Liposomal Bupivacaine vs. Bupivacaine for Total Hip Replacement Pain Management

NCT03001453 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2018-07-26

Study results available
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Summary

The purpose of this study is to compare two medications currently injected intra-operatively to help decrease pain after surgery in patients undergoing a primary total hip replacement (THR). The two medications are Exparel® (bupivacaine liposome injectable suspension) plus bupivacaine with epinephrine versus bupivacaine with epinephrine. This study is looking to see if one medication works better than the other in managing post-operative pain after THR. The study hypothesis is that Exparel® plus bupivacaine with epinephrine will demonstrate better pain management in THR patients post-operatively. Both medications are FDA-approved for post-operative analgesia.

Conditions

  • Pain, Postoperative

Interventions

DRUG

Liposomal Bupivacaine

266mg liposomal bupivacaine

DRUG

0.25% Bupivacaine with epinephrine

0.25% bupivacaine with epinephrine

DRUG

Saline

Normal saline

Sponsors & Collaborators

  • American Hip Institute

    lead OTHER

Principal Investigators

  • Benjamin G Domb, MD · American Hip Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2016-03-31
Completion
2016-03-31

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 NCT03001453 on ClinicalTrials.gov