Efficacy of an Epidural Versus a Fascia Iliaca Compartment Catheter After Hip Surgery

August 9, 2017 updated by: Luke Y. Wang, Boston Children's Hospital

A Prospective, Randomized, Double-blind, Placebo-controlled, Crossover Trial of Epidural Analgesia Versus a Surgically-placed Fascia Iliaca Compartment Catheter for Postoperative Pain After Periacetabular Osteotomy

The investigators are investigating two ways of treating pain after hip surgery. One way is though a thin tube (called a catheter), and it is placed into the back so that pain-numbing drugs can reach the nerves near the backbone. This is called an "epidural" catheter. Another way is to place the catheter close to the hip, where the surgery is done, so that the pain-numbing drugs can reach some of the nerves more locally. This is called a "fascia iliaca compartment" catheter.

The investigators do not know which way is best to treat pain, or has fewer side effects, or allows a patient to leave hospital faster. Usually, patients would receive only one type of catheter for pain relief. To do this comparison, the investigators would place both catheter types, so that patients help us tell which one works better.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Boston Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 35 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Weight >40 kg
  • Radiographic evidence of hip dysplasia amenable to unilateral surgical treatment by periacetabular osteotomy
  • Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain subscale >4/20
  • Age between 15 and 35 years
  • Good or excellent preoperative joint congruency

Exclusion Criteria:

  • Hematologic or neurologic contraindications to epidural catheter placement
  • Significant renal, hepatic, or cardiac disease
  • Peptic ulcer disease
  • Bleeding disorders
  • Severe asthma
  • Hypersensitivity to non-steroidal antiinflammatory drugs
  • Developmental delay
  • History of substance abuse
  • Chronic opioid use
  • Chronic pain in non-hip locations

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Epidural
Epidural catheter is used postoperatively
Procedure: Epidural catheter is used postoperatively
Experimental: Fascia Iliaca Compartment
Fascia iliaca compartment catheter is used postoperatively
Procedure: Fascia iliaca compartment catheter is used postoperatively

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of days until all pre-defined readiness-to-discharge criteria for hip surgery are met
Time Frame: 1-5 days
  1. Numerical pain rating score <4 at rest, and <6 with movement,
  2. Independence from intravenous opioids for 12 hours, and
  3. Ambulation at least 30 m, without a time limit
1-5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Children's Hospital

Investigators

  • Principal Investigator: Luke Y Wang, MD, Boston Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

April 16, 2013

First Submitted That Met QC Criteria

April 17, 2013

First Posted (Estimate)

April 18, 2013

Study Record Updates

Last Update Posted (Actual)

August 10, 2017

Last Update Submitted That Met QC Criteria

August 9, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3650

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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