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Low Dose Extended-release Epidural and Lumbar Plexus Block Compared to Lumbar Plexus Block for Total Hip Resurfacing

NCT00934661 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-09-12

Study results available
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Summary

At Wake Forest University, the investigators have been using Extended Release Epidural Morphine (EREM), since late 2004, as part of multimodal analgesia in patients having gynecologic surgeries and hip arthroplasties.

Hypothesis:

In patients undergoing a Birmingham total hip arthroplasty (BHA), low dose EREM in conjunction with lumbar plexus block (LPB) will be better than lumbar plexus block alone in increasing proportion of patients who meet discharge criteria within 24 hours.

Conditions

  • Hip Arthroplasty

Interventions

DRUG

Extended Release Epidural Morphine (EREM)

A single Four mg (0.4 ml)dose of EREM will be administered into the epidural space and flushed with 1 ml of saline

DRUG

Placebo

A single epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush

Sponsors & Collaborators

  • EKR Therapeutics, Inc

    collaborator INDUSTRY

  • Wake Forest University

    lead OTHER

Principal Investigators

  • Pamela C Nagle, M.D. · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2013-03-31
Completion
2013-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT00934661 on ClinicalTrials.gov