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NCT Number: NCT03375112

Fascia Iliaca Blocks for Pain Control After Total Hip Arthroplasty

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.

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Key information

Conditions

Arthritis of Hip Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fascia iliaca compartment block

Procedure

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.

Placebo

Drug

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.

Bupivacaine

Drug

A one time dose of 40 milliliters of 0.5% bupivacaine will be injected into the fascia iliaca compartment

Primary outcomes

  1. Averaged Pain Score

    Time frame: 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.

    Analog pains scale 0-10. A pain score of 10 represents maximum pain and a pain score of 0 represents no pain.

  2. Morphine Equivalents Consumed

    Time frame: Postoperative inpatient stay, which averages approximately two days.

    Total morphine equivalents (consumed at 4-hour time intervals) received in postoperative inpatient stay.

Secondary outcomes

  1. Walking Distance

    Time frame: Post operative day one

    The distance the patient is able to walk with physical therapy during their first session

  2. Time to Up-and-go

    Time frame: Post operative day one

    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.

  3. Time to Discharge Readiness

    Time frame: Every 6 hours after surgery until completion of inpatient stay, an average of two days days after surgery

    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.

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 15, 2017
Registry last updated
Oct 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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