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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Children's Hospital Boston
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01835106
First received: April 16, 2013
Last updated: April 17, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Postoperative Pain
Procedure: Epidural catheter is used postoperatively
Procedure: Fascia iliaca compartment catheter is used postoperatively

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • Number of days until all pre-defined readiness-to-discharge criteria for hip surgery are met [ Time Frame: 1-5 days ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 80
Study Start Date: April 2013
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   15 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01835106

Contacts
Contact: Gloria Boye 1-617-355-6211

Locations
United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Gloria Boye    617-355-6211      
Sponsors and Collaborators
Children's Hospital Boston
Investigators
Principal Investigator: Luke Y Wang, MD Children's Hospital Boston
  More Information

No publications provided

Responsible Party: Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT01835106     History of Changes
Other Study ID Numbers: 3650
Study First Received: April 16, 2013
Last Updated: April 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Boston:
Postoperative Care

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014