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

Study Overview
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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.

Official Title
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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

Conditions
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Postoperative Pain

Intervention / Treatment
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* Procedure: Epidural catheter is used postoperatively
* Procedure: Fascia iliaca compartment catheter is used postoperatively


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Epidural<br>Epidural catheter is used postoperatively | Procedure: Epidural catheter is used postoperatively<br> <br> |
| Experimental: Fascia Iliaca Compartment<br>Fascia iliaca compartment catheter is used postoperatively | Procedure: Fascia iliaca compartment catheter is used postoperatively<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1-5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative Care