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

This study has been withdrawn prior to enrollment.
(The study was proposed but never started due to other commitments)
Sponsor:
Information provided by (Responsible Party):
Luke Y. Wang, Boston Children's Hospital
ClinicalTrials.gov Identifier:
NCT01835106
First received: April 16, 2013
Last updated: August 9, 2017
Last verified: August 2017
  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 (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

Further study details as provided by Luke Y. Wang, Boston Children's Hospital:

Primary Outcome Measures:
  • 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


Enrollment: 0
Study Start Date: April 2013
Study Completion Date: April 2013
Primary Completion Date: April 2013 (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   (Child, Adult)
Sexes Eligible for Study:   All
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

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

Responsible Party: Luke Y. Wang, Instructor in Anesthesia, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT01835106     History of Changes
Other Study ID Numbers: 3650
Study First Received: April 16, 2013
Last Updated: August 9, 2017

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

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

ClinicalTrials.gov processed this record on August 22, 2017