A Phase 4 interventional study of Fascia iliaca compartment block and Placebo in Arthritis of Hip, sponsored by Henry Ford Health System. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-10.
Sponsored by Henry Ford Health System · Phase 4, Interventional, and Supportive care
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.
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.
Henry Ford Health System is the lead sponsor of 303 studies on the registry; 50 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 26 (70%) have results posted.
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A Fascia Iliaca Compartment Block will be administered in the block room.
Procedure: Fascia iliaca compartment block · Drug: Bupivacaine
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
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.
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.
A one time dose of 40 milliliters of 0.5% bupivacaine will be injected into the fascia iliaca compartment
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.
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.
Morphine Equivalents Consumed
Total morphine equivalents (consumed at 4-hour time intervals) received in postoperative inpatient stay.
Time frame: Postoperative inpatient stay, which averages approximately two days.
Walking Distance
The distance the patient is able to walk with physical therapy during their first session
Time frame: Post operative day one
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 frame: Post operative day one
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.
Time frame: Every 6 hours after surgery until completion of inpatient stay, an average of two days days after surgery
| Milestone | Fascia Iliaca Compartment Block | Control |
|---|---|---|
| Started | 62 | 60 |
| Completed | 59 | 60 |
| Not completed | 3 | 0 |
| Withdrew: Withdrawal by subject | 3 | 0 |
Analog pains scale 0-10. A pain score of 10 represents maximum pain and a pain score of 0 represents no pain.
| score on a scale | Fascia Iliaca Compartment Block | Control |
|---|---|---|
| Averaged Pain Score | 3.75 (3.5 to 5.8) | 4.11 (1.9 to 5) |
Total morphine equivalents (consumed at 4-hour time intervals) received in postoperative inpatient stay.
| morphine milliequivalents | Fascia Iliaca Compartment Block | Control |
|---|---|---|
| Morphine Equivalents Consumed | 75.3 ± 43.4 | 86.0 ± 55.6 |
The distance the patient is able to walk with physical therapy during their first session
| Feet | Fascia Iliaca Compartment Block | Control |
|---|---|---|
| Walking Distance | 67.1 ± 59.1 | 68.3 ± 54.0 |
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.
| Seconds | Fascia Iliaca Compartment Block | Control |
|---|---|---|
| Time to Up-and-go | 63.7 ± 62.8 | 66.3 ± 63.9 |
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.
| hours | Fascia Iliaca Compartment Block | Control |
|---|---|---|
| Time to Discharge Readiness | 35.1 ± 12.8 | 35.2 ± 11.8 |
Collected over Adverse events were monitored during the initial inpatient recovery period (up to postoperative day 2), and during the routine follow-up clinical visits (at two weeks and six weeks).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fascia Iliaca Compartment Block | 0/59 (0%) | 0/59 (0%) | 0/59 (0%) |
| Control | 0/60 (0%) | 0/60 (0%) | 0/60 (0%) |
| Age, Continuous(Years) | Fascia Iliaca Compartment Block | Control | Total |
|---|---|---|---|
| Mean | 62.9 ± 12.8 | 63.6 ± 10.3 | 63.3 ± 11.7 |
| Sex: Female, Male(Participants) | Fascia Iliaca Compartment Block | Control | Total |
|---|---|---|---|
| Female | 31 | 36 | 67 |
| Male | 28 | 24 | 52 |
| Race and Ethnicity Not Collected(Participants) | Fascia Iliaca Compartment Block | Control | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Primary Osteoarthritis(Participants) | Fascia Iliaca Compartment Block | Control | Total |
|---|---|---|---|
| Count of participants | 57 | 59 | 116 |
| Smoking(Participants) | Fascia Iliaca Compartment Block | Control | Total |
|---|---|---|---|
| Count of participants | 2 | 3 | 5 |
| Prior Opioids use(Participants) | Fascia Iliaca Compartment Block | Control | Total |
|---|---|---|---|
| Count of participants | 2 | 2 | 4 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from Jul 2017 to primary completion in Oct 2019, 26 months.
Results were first posted in Oct 2023, 4 years after primary completion.
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Studies of the drug tested here: Bupivacaine
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