Fascia Iliaca Blocks for Pain Control After Total Hip Arthroplasty

NCT ID: NCT03375112

Last Updated: 2023-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-31
• Study Completion Date: 2019-10-01

Brief 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.

Detailed 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.

Conditions

Arthritis of Hip

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Fascia Iliaca Compartment Block

A Fascia Iliaca Compartment Block will be administered in the block room.

Group Type: EXPERIMENTAL

Fascia iliaca compartment block

Intervention Type: 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.

Bupivacaine

Intervention Type: DRUG

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

Control

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: DRUG

Bupivacaine

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henry Ford Health System

OTHER

Sponsor Role: lead

Responsible Party

Michael Charters, MD

Orthopac Surgeon, Department of Joint Replacement and Reconstruction

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Charters, MD

Role: PRINCIPAL_INVESTIGATOR

Henry Ford Hospital

Locations

Henry Ford Hospital

Detroit, Michigan, United States

Countries

United States

References

Bober K, Kadado A, Charters M, Ayoola A, North T. Pain Control After Total Hip Arthroplasty: A Randomized Controlled Trial Determining Efficacy of Fascia Iliaca Compartment Blocks in the Immediate Postoperative Period. J Arthroplasty. 2020 Jun;35(6S):S241-S245. doi: 10.1016/j.arth.2020.02.020. Epub 2020 Feb 14.

Reference Type: DERIVED

PMID: 32222267 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

FICB01

Identifier Type: -

Identifier Source: org_study_id