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Fascia Iliaca Blocks for Pain Control After Total Hip Arthroplasty

Primary Purpose

Arthritis of Hip

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Fascia iliaca compartment block
Placebo
Bupivacaine
Sponsored by
Henry Ford Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Arthritis of Hip focused on measuring Total Hip Arthroplasty, Fascia Iliaca, Nerve Block, Pain Control

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Henry Ford Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Fascia Iliaca Compartment Block

Control

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 22, 2017
Last Updated
September 21, 2023
Sponsor
Henry Ford Health System
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1. Study Identification

Unique Protocol Identification Number
NCT03375112
Brief Title
Fascia Iliaca Blocks for Pain Control After Total Hip Arthroplasty
Official Title
Pain Control After Total Hip Arthroplasty: A Randomized Trial Determining Efficacy of Fascia Iliaca Compartment Blocks in the Immediate Post-Operative Period
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
July 31, 2017 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
October 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis of Hip
Keywords
Total Hip Arthroplasty, Fascia Iliaca, Nerve Block, Pain Control

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
122 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fascia Iliaca Compartment Block
Arm Type
Experimental
Arm Description
A Fascia Iliaca Compartment Block will be administered in the block room.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Fascia iliaca compartment block
Intervention Description
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
Drug
Intervention Name(s)
Placebo
Intervention Description
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
Intervention Name(s)
Bupivacaine
Intervention Description
A one time dose of 40 milliliters of 0.5% bupivacaine will be injected into the fascia iliaca compartment
Primary Outcome Measure Information:
Title
Averaged Pain Score
Description
Analog pains scale 0-10. A pain score of 10 represents maximum pain and a pain score of 0 represents no pain.
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.
Title
Morphine Equivalents Consumed
Description
Total morphine equivalents (consumed at 4-hour time intervals) received in postoperative inpatient stay.
Time Frame
Postoperative inpatient stay, which averages approximately two days.
Secondary Outcome Measure Information:
Title
Walking Distance
Description
The distance the patient is able to walk with physical therapy during their first session
Time Frame
Post operative day one
Title
Time to Up-and-go
Description
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.
Time Frame
Post operative day one
Title
Time to Discharge Readiness
Description
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.
Time Frame
Every 6 hours after surgery until completion of inpatient stay, an average of two days days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Charters, MD
Organizational Affiliation
Henry Ford Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32222267
Citation
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.
Results Reference
derived

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Fascia Iliaca Blocks for Pain Control After Total Hip Arthroplasty

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