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Intraoperative Liposomal Bupivacaine Injection in Primary Total Knee Arthroplasty

NCT02341079 · Status: WITHDRAWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2017-03-10

No results posted yet for this study

Summary

The purpose of the study is to evaluate the efficacy of local infiltration of liposomal bupivacaine versus use of an indwelling femoral peripheral nerve block in controlling early postoperative pain in primary total knee arthroplasty. The investigators hope to demonstrate equivalency of treatment modalities to provide an alternative to the commonly used treatment of femoral nerve blockade.

Conditions

  • Osteoarthritis
  • Osteoarthritis, Knee
  • Arthritis, Degenerative
  • Osteoarthrosis
  • Osteoarthrosis Deformans

Interventions

DRUG

Bupivacaine Liposome Injection

Intraoperative intracapsular injection of 266mg of bupivacaine liposome injection diluted to 60mL with 0.9% normal saline.

DRUG

Indwelling femoral nerve block

Femoral nerve block delivered via indwelling femoral nerve catheter with 0.125% bupivacaine.

Sponsors & Collaborators

  • United States Naval Medical Center, San Diego

    lead FED

Principal Investigators

  • Patrick B Morrissey, M.D. · Naval Medical Center San Diego Department of Orthopadic Surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT02341079 on ClinicalTrials.gov