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

NCT ID: NCT01835106

Last Updated: 2017-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2013-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Epidural

Epidural catheter is used postoperatively

Group Type ACTIVE_COMPARATOR

Epidural catheter is used postoperatively

Intervention Type PROCEDURE

Fascia Iliaca Compartment

Fascia iliaca compartment catheter is used postoperatively

Group Type EXPERIMENTAL

Fascia iliaca compartment catheter is used postoperatively

Intervention Type PROCEDURE

Interventions

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Epidural catheter is used postoperatively

Intervention Type PROCEDURE

Fascia iliaca compartment catheter is used postoperatively

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Luke Y. Wang

Instructor in Anesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Luke Y Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

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Boston Children's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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3650

Identifier Type: -

Identifier Source: org_study_id

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