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

Primary Purpose

Postoperative Pain

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Epidural catheter is used postoperatively
Fascia iliaca compartment catheter is used postoperatively
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Postoperative Care

Eligibility Criteria

15 Years - 35 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Boston Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Epidural

Fascia Iliaca Compartment

Arm Description

Epidural catheter is used postoperatively

Fascia iliaca compartment catheter is used postoperatively

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 16, 2013
Last Updated
August 9, 2017
Sponsor
Boston Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01835106
Brief Title
Efficacy of an Epidural Versus a Fascia Iliaca Compartment Catheter After Hip Surgery
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 Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Withdrawn
Why Stopped
The study was proposed but never started due to other commitments
Study Start Date
April 2013 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Postoperative Care

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Epidural
Arm Type
Active Comparator
Arm Description
Epidural catheter is used postoperatively
Arm Title
Fascia Iliaca Compartment
Arm Type
Experimental
Arm Description
Fascia iliaca compartment catheter is used postoperatively
Intervention Type
Procedure
Intervention Name(s)
Epidural catheter is used postoperatively
Intervention Type
Procedure
Intervention Name(s)
Fascia iliaca compartment catheter is used postoperatively
Primary Outcome Measure Information:
Title
Number of days until all pre-defined readiness-to-discharge criteria for hip surgery are met
Description
Numerical pain rating score <4 at rest, and <6 with movement, Independence from intravenous opioids for 12 hours, and Ambulation at least 30 m, without a time limit
Time Frame
1-5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luke Y Wang, MD
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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