Fascia Iliaca Blocks for Pain Control After Total Hip Arthroplasty

NCT03375112 | Completed Phase 4 Results FDA Drug

• 1 other identifier: FICB01
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthritis of Hip

Keywords

Total Hip Arthroplasty; Fascia Iliaca; Nerve Block; Pain Control

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Walking Distance

  Post operative day one

• Time to Up-and-go

  Post operative day one

• Time to Discharge Readiness

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

Study Arms (2)

Fascia Iliaca Compartment Block

EXPERIMENTAL

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

Procedure: Fascia iliaca compartment block; Drug: Bupivacaine

Control

PLACEBO COMPARATOR

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

Interventions

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.

Fascia Iliaca Compartment Block

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.

Control

Bupivacaine DRUG

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

Fascia Iliaca Compartment Block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over the age of 18
• Scheduled for total hip arthroplasty at Henry Ford Hospital
• Epidural anesthesia during surgery

You may not qualify if:

• Pregnancy
• Known intolerance to local anesthetic or narcotics
• Revision hip surgery

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Related Publications (1)

• 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.

  PMID: 32222267 DERIVED

MeSH Terms

Conditions

Agnosia

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr. Michael Charters
• Organization: Henry Ford Health System

mcharte1@hfhs.org

1-800-436-7936

Study Officials

• Michael Charters, MD

  Henry Ford Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The patients will be randomized to receive fascia iliaca blocks post-operatively or to receive a touch with a blunt needle and a bandaid post-operatively by the regional anesthesia team. Neither the patient nor the investigators will have knowledge of which group the patients belong to until the completion of the data collection.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopac Surgeon, Department of Joint Replacement and Reconstruction

Study Record Dates

• First Submitted: March 22, 2017
• First Posted: December 15, 2017
• Study Start: July 31, 2017
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: October 10, 2023
• Results First Posted: October 10, 2023

Record last verified: 2023-09

Locations

US (1)