Clinical trial NCT03375112
Conditions: Arthritis of Hip
Keywords: Total Hip Arthroplasty Fascia Iliaca Nerve Block Pain Control
Sponsor: Henry Ford Health System
Start date: 2017-07-31; Completion date: 2019-10-01
Enrollment: 122 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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.

Arms: arm 1: A Fascia Iliaca Compartment Block will be administered in the block room. arm 2: 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.
Interventions: intervention 1: Fascia iliaca compartment block intervention 2: Placebo intervention 3: Bupivacaine
Intervention descriptions: intervention 1: 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 2: 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 3: A one time dose of 40 milliliters of 0.5% bupivacaine will be injected into the fascia iliaca compartment

Protocol documents:
Prot_SAP_002.pdf: 
Pain Control After Total Hip Arthroplasty: A Randomized Trial Determining Efficacy of 
Fascia Iliaca Compartment Blocks in the Immediate Post-Operative Period   
Contact Person: Kamil Bober, MD  
Contact phone #: 7738292348  
Contact e-mail: kbober1@hfhs.org 
Current source of funding: Orthopedic department research fund, GME resident research fund  
Is this study currently NIH funded? No 
NCT number: NCT03375112 
Date modified: 9/21/2023 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Protocol: 


The purpose of this project is to study the effectiveness of nerve blockade to improve pain 
control after total hip arthroplasty. Specifically, this study seeks to identify if the fascia iliaca 
compartment blockade provides additional pain relief and decreased morphine consumption 
when used in conjunction with a multimodal pain control regimen.Patients are consented and 
recruited according to the inclusion and exclusion criteria of the study at their pre-operative visit 
1-2 weeks prior to their scheduled surgical date. All patients recieve a total hip replacement via 
the posterior approach. After surgery the patients are brought to the block room where a 
randomization table is used to randomize patients to the placebo or block group. If in the block 
group a senior trained anesthesiologist then performs a fascia iliaca block, infusing the standard 
volume of 40 mL of bupivicaine under ultrasound guidance. If in the placebo group the 
anesthesiologist only places the ultrasound probe to the skin for the length of time it would take 
to normally perform a block. At the end, a bandaid is placed at the injection site for all paitents. 
Following the procedure, pain is assessed while inpatient on post operative days one and two, as 
well as during the first postoperative visit (3-4 weeks after surgery). There is standard daily 
monitoring and team rouding. Patients are assessed subjectively with visual analog scale and 
numeric rating scale pain scores. Patients are routinely seen 6 hours after surgery for a post op 
check, and in the morning of post operative days one and two for morning rounds. At these 
encounters, pain levels again are recorded, as well as strength of straight leg raise. Patients are 
also given a chart to record their pain levels every 6 hours after surgery while they are awake. 
Each patient is given a stop watch during the hospital stay that reminds them to record their own 
pain level on the chart. Patients work with physical therapy per existing protocol, who record 
distance walked, pain level with ambulation, and a time-to-up-and-go test. The morphine 
equivalents consumed per each six hour interval will be obtained from the electronic medical 
record (already standard protocol) and the times to discharge readiness will be calculated in 
hours. Data will primarily be obtained from daily progress notes, existing medical record 
flowsheets, and data collection sheets filled out by the patients. 
 
Enrollment 
Number of participants: 120 
 
Privacy 
Where are the names of research subjects kept? In a locked cabinet in the anesthesia department 
Where are signed original consent forms kept? In a locked closet in the orthopedic department 
What provisions do you have in place to ensure confidentiality of data? Secure information is 
kept in 2 locations: a secured electronic spreadsheet for data collection and paper records. Paper 
records are kept in a locked file with key access available only to the senior study personnel. 
Study information is stored in a password-protected spreadsheet file. Individual patients are de-
identified by a unique coded identifier which corresponds to the patient MRN kept in paper 
format in a separate location. Only key study personnel will have access to the data. 


 
Conflict of Interest 
Principal Investigator: Do you or any member of your family have a compensated 
arrangement(s) or have you personally received any compensation (not including honorarium for 
reviewing federally-funded grants) or investment interest from any organization that funds your 
research, or has the potential to benefit from the results?  
NO 
 
Personnel 
Michael Charters, MD 
Trevor North, MD 
Craig Silverton, MD 
Kamil Bober, MD 
M. Chad Mahan, MD 
Mohamed-Rida, Alsaden 
Christina Fidowski, MD 
Nandak Choksi, MD 
 
Statistical Analysis Plan 
All statistics were performed using STATA software (StataCorp). Student’s t-tests were used to 
compare independent continuous variables. Repeated measure of analysis of variance testing was 
used to compare pain scores at each time interval. Chi-squared tests were used to compare 
categorical variables. A power analysis was calculated to determine the sample size used in the 
study. At an alpha value of 0.05 and using 2-sided testing, a sample size of 60 patients per group 
was needed to detect a difference of 1.3 in pain scores and 9.0 in morphine equivalents 
consumed with 80% power. Differences of this magnitude would be considered clinically 
significant. Effect sizes and standard deviations were obtained from a literature review.