Fascia Iliaca Blocks for Pain Control After Total Hip Arthroplasty

Arthritis of Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03375112
• Other study ID #: FICB01
• Status: Completed
• Phase: Phase 4
• Start date: July 31, 2017
• Est. completion date: October 1, 2019

Study information

• Verified date: September 2023
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: October 1, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis of Hip

Intervention

Procedure:
• Fascia iliaca compartment block
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.

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

Locations

Country	Name	City	State
United States	Henry Ford Hospital	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Walking Distance	The distance the patient is able to walk with physical therapy during their first session	Post operative day one
Secondary	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
Secondary	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