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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fascia Iliaca Compartment Block | Experimental | A Fascia Iliaca Compartment Block will be administered in the block room. |
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| Control | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fascia iliaca compartment block | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Postoperative inpatient stay, which averages approximately two days. |
| Measure | Description | Time Frame |
|---|---|---|
| Walking Distance | The distance the patient is able to walk with physical therapy during their first session | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Charters, MD | Henry Ford Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32222267 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Full Range | score on a scale | 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. |
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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).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael Charters | Henry Ford Health System | 1-800-436-7936 | mcharte1@hfhs.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 21, 2023 | Sep 21, 2023 | Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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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.
|
| Placebo | Drug | 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. |
|
| Bupivacaine | Drug | A one time dose of 40 milliliters of 0.5% bupivacaine will be injected into the fascia iliaca compartment |
|
| 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. | Every 6 hours after surgery until completion of inpatient stay, an average of two days days after surgery |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Primary Osteoarthritis | Count of Participants | Participants |
|
| Smoking | Count of Participants | Participants |
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| Prior Opioids use | Count of Participants | Participants |
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| OG001 | 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. |
|
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| Primary | Morphine Equivalents Consumed | Total morphine equivalents (consumed at 4-hour time intervals) received in postoperative inpatient stay. | Posted | Mean | Standard Deviation | morphine milliequivalents | Postoperative inpatient stay, which averages approximately two days. |
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| Secondary | Walking Distance | The distance the patient is able to walk with physical therapy during their first session | Posted | Mean | Standard Deviation | Feet | Post operative day one |
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| 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. | Posted | Mean | Standard Deviation | Seconds | Post operative day one |
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| 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. | Posted | Mean | Standard Deviation | hours | Every 6 hours after surgery until completion of inpatient stay, an average of two days days after surgery |
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| 0 |
| 59 |
| 0 |
| 59 |
| 0 |
| 59 |
| EG001 | 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. | 0 | 60 | 0 | 60 | 0 | 60 |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000588 |
| Amines |