Clinical trial NCT03375112: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Arthritis of Hip
Keywords: Total Hip Arthroplasty
Fascia Iliaca
Nerve Block
Pain Control
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2017-12-15
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Averaged Pain Score
timeFrame: 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.
measure: Morphine Equivalents Consumed
timeFrame: Postoperative inpatient stay, which averages approximately two days.
Secondary outcomes:
measure: Walking Distance
timeFrame: Post operative day one
measure: Time to Up-and-go
timeFrame: Post operative day one
measure: Time to Discharge Readiness
timeFrame: Every 6 hours after surgery until completion of inpatient stay, an average of two days days after surgery
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
Study officials:
affiliation: Henry Ford Hospital
name: Michael Charters, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.