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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01835106
Recruitment Status : Withdrawn (The study was proposed but never started due to other commitments)
First Posted : April 18, 2013
Last Update Posted : August 10, 2017
Information provided by (Responsible Party):
Luke Y. Wang, Boston Children’s Hospital

Brief Summary:

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 or disease Intervention/treatment Phase
Postoperative Pain Procedure: Epidural catheter is used postoperatively Procedure: Fascia iliaca compartment catheter is used postoperatively Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
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
Study Start Date : April 2013
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

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

Primary Outcome Measures :
  1. 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

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Ages Eligible for Study:   15 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01835106

United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children’s Hospital
Principal Investigator: Luke Y Wang, MD Boston Children’s Hospital

Responsible Party: Luke Y. Wang, Instructor in Anesthesia, Boston Children’s Hospital Identifier: NCT01835106     History of Changes
Other Study ID Numbers: 3650
First Posted: April 18, 2013    Key Record Dates
Last Update Posted: August 10, 2017
Last Verified: August 2017

Keywords provided by Luke Y. Wang, Boston Children’s Hospital:
Postoperative Care

Additional relevant MeSH terms:
Pain, Postoperative
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms