Fascia Iliaca Blocks for Pain Control After Total Hip Arthroplasty

Study Overview
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Brief Summary
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The fascia iliaca compartment block (FICB) is a regional block that anesthetizes the femoral, obturator, and lateral femoral cutaneous nerves around the hip. The purpose of this study is to determine whether FICB can reduce postoperative pain and increase progress with physical therapy after total hip arthroplasty (THA). This randomized, double-blind, clinical trial will randomize patients to receive either a FICB or placebo after THA. The primary outcomes will be pain scores reported by the patient post-operatively.

Detailed Description
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The FICB is a regional block that anesthetizes the femoral, obturator, and lateral femoral cutaneous nerves around the hip joint. There have been numerous study assessing it's ability to control pain in the pre and post operative period in patients with hip fractures. However, there is a limited amount of literature on its efficacy after total hip arthroplasty, and no data when a posterior surgical approach to the hip was utilized. Because regional blocks have been shown to decrease pain post operatively after total knee arthroplasty, we hypothesize that the FICB will decrease pain and narcotic use in patients after total hip arthroplasty. This study will aim to recruit 120 patients that will be randomized to receive a FICB or placebo in the recovery room within 30 minutes of leaving the OR. Once the intervention is complete we will collect data on the patients' pain levels, morphine equivalents of narcotic that they used, and how well they worked with physical therapy during their inpatient stay.

Official Title
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Pain Control After Total Hip Arthroplasty: A Randomized Trial Determining Efficacy of Fascia Iliaca Compartment Blocks in the Immediate Post-Operative Period

Conditions
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Arthritis of Hip

Intervention / Treatment
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* Procedure: Fascia iliaca compartment block
* Drug: Placebo
* Drug: Bupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients over the age of 18 Scheduled for total hip arthroplasty at Henry Ford Hospital Epidural anesthesia during surgery Exclusion Criteria: Pregnancy Known intolerance to local anesthetic or narcotics Revision hip surgery

Ages Eligible for Study
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Minimum Age: 18 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fascia Iliaca Compartment Block<br>A Fascia Iliaca Compartment Block will be administered in the block room. | Procedure: Fascia iliaca compartment block<br>* The patient will be brought to the block room within 30 minutes of arriving in recovery. An injection of local anesthetic into the fascia iliaca compartment using ultrasound guidance will be administered. The patient will then be transported back to recovery.<br>Drug: Bupivacaine<br>* A one time dose of 40 milliliters of 0.5% bupivacaine will be injected into the fascia iliaca compartment<br>|
| Placebo Comparator: Control<br>The patients will be brought back to the block room, prepped, and a blunt needle will be touched to the skin. A band aid will be applied over the site. | Drug: Placebo<br>* The patient will be brought to the block room within 30 minutes of arriving in recovery. An ultrasound probe will be placed to the skin and a blunt needle will be touched to the patient's skin in the area that a fascia iliaca compartment block would be performed. The patient will then be transported back to recovery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Averaged Pain Score | Analog pains scale 0-10. A pain score of 10 represents maximum pain and a pain score of 0 represents no pain. | Pain scores were at 30 minute intervals for the first hour post-operative, hourly for the next 4 hours, 2 hour intervals for the next 12 hours, then at 4 hour intervals until the 48 hour post-operative or discharge. The mean of these scores is reported. | 
| Morphine Equivalents Consumed | Total morphine equivalents (consumed at 4-hour time intervals) received in postoperative inpatient stay. | Postoperative inpatient stay, which averages approximately two days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Walking Distance | The distance the patient is able to walk with physical therapy during their first session | Post operative day one | 
| Time to Up-and-go | Time to up and go test performed on the first postoperative day. This test is administered by having the patient sit in a chair. When the patient is instructed to start, the stand from the chair, walk to a marker ten feet away from the chair, turn around, return to the chair, and sit back down. The time is measured as the time from when the start command is given to when they are returned to a seated position. | Post operative day one | 
| Time to Discharge Readiness | Time in hours since surgery to when the patient's pain is controlled on oral medications, has cleared physical and occupational therapy, and has no medical issues that require inpatient treatment. | Every 6 hours after surgery until completion of inpatient stay, an average of two days days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Hip Arthroplasty, Fascia Iliaca, Nerve Block, Pain Control