Arthritis of Hip
Conditions
Keywords
Total Hip Arthroplasty, Fascia Iliaca, Nerve Block, Pain Control
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.
Interventions
PROCEDUREFascia iliaca compartment block
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.
DRUGPlacebo
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.
DRUGBupivacaine
A one time dose of 40 milliliters of 0.5% bupivacaine will be injected into the fascia iliaca compartment
Sponsors
Henry Ford Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Averaged Pain Score | 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. | 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 | Postoperative inpatient stay, which averages approximately two days. | Total morphine equivalents (consumed at 4-hour time intervals) received in postoperative inpatient stay. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Walking Distance | Post operative day one | The distance the patient is able to walk with physical therapy during their first session |
| Time to Up-and-go | Post operative day one | 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 | Every 6 hours after surgery until completion of inpatient stay, an average of two days days after surgery | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fascia Iliaca Compartment Block A Fascia Iliaca Compartment Block will be administered in the block room.
Fascia iliaca compartment block: 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.
Bupivacaine: A one time dose of 40 milliliters of 0.5% bupivacaine will be injected into the fascia iliaca compartment | 59 |
| Control 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.
Placebo: 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. | 60 |
| Total | 119 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 3 | 0 |
Baseline characteristics
| Characteristic | Control | Total | Fascia Iliaca Compartment Block |
|---|---|---|---|
| Age, Continuous | 63.6 Years STANDARD_DEVIATION 10.3 | 63.3 Years STANDARD_DEVIATION 11.7 | 62.9 Years STANDARD_DEVIATION 12.8 |
| Primary Osteoarthritis | 59 Participants | 116 Participants | 57 Participants |
| Prior Opioids use | 2 Participants | 4 Participants | 2 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Sex: Female, Male Female | 36 Participants | 67 Participants | 31 Participants |
| Sex: Female, Male Male | 24 Participants | 52 Participants | 28 Participants |
| Smoking | 3 Participants | 5 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 59 | 0 / 60 |
| other Total, other adverse events | 0 / 59 | 0 / 60 |
| serious Total, serious adverse events | 0 / 59 | 0 / 60 |
Outcome results
Primary
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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Fascia Iliaca Compartment Block | Averaged Pain Score | 3.75 score on a scale |
| Control | Averaged Pain Score | 4.11 score on a scale |
Primary
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fascia Iliaca Compartment Block | Morphine Equivalents Consumed | 75.3 morphine milliequivalents | Standard Deviation 43.4 |
| Control | Morphine Equivalents Consumed | 86.0 morphine milliequivalents | Standard Deviation 55.6 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fascia Iliaca Compartment Block | Time to Discharge Readiness | 35.1 hours | Standard Deviation 12.8 |
| Control | Time to Discharge Readiness | 35.2 hours | Standard Deviation 11.8 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fascia Iliaca Compartment Block | Time to Up-and-go | 63.7 Seconds | Standard Deviation 62.8 |
| Control | Time to Up-and-go | 66.3 Seconds | Standard Deviation 63.9 |
Secondary
Walking Distance
The distance the patient is able to walk with physical therapy during their first session
Time frame: Post operative day one
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fascia Iliaca Compartment Block | Walking Distance | 67.1 Feet | Standard Deviation 59.1 |
| Control | Walking Distance | 68.3 Feet | Standard Deviation 54 |