Trial Outcomes & Findings for Fascia Iliaca Blocks for Pain Control After Total Hip Arthroplasty (NCT NCT03375112)
NCT ID: NCT03375112
Last Updated: 2023-10-10
Results Overview
Analog pains scale 0-10. A pain score of 10 represents maximum pain and a pain score of 0 represents no pain.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
122 participants
Primary outcome 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.
Results posted on
2023-10-10
Participant Flow
Participant milestones
| Measure |
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
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
62
|
60
|
|
Overall Study
COMPLETED
|
59
|
60
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
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
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Fascia Iliaca Compartment Block
n=59 Participants
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
|
Control
n=60 Participants
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.
|
Total
n=119 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.9 Years
STANDARD_DEVIATION 12.8 • n=59 Participants
|
63.6 Years
STANDARD_DEVIATION 10.3 • n=60 Participants
|
63.3 Years
STANDARD_DEVIATION 11.7 • n=119 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=59 Participants
|
36 Participants
n=60 Participants
|
67 Participants
n=119 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=59 Participants
|
24 Participants
n=60 Participants
|
52 Participants
n=119 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Primary Osteoarthritis
|
57 Participants
n=59 Participants
|
59 Participants
n=60 Participants
|
116 Participants
n=119 Participants
|
|
Smoking
|
2 Participants
n=59 Participants
|
3 Participants
n=60 Participants
|
5 Participants
n=119 Participants
|
|
Prior Opioids use
|
2 Participants
n=59 Participants
|
2 Participants
n=60 Participants
|
4 Participants
n=119 Participants
|
PRIMARY outcome
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.Analog pains scale 0-10. A pain score of 10 represents maximum pain and a pain score of 0 represents no pain.
Outcome measures
| Measure |
Fascia Iliaca Compartment Block
n=59 Participants
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
|
Control
n=60 Participants
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.
|
|---|---|---|
|
Averaged Pain Score
|
3.75 score on a scale
Interval 3.5 to 5.8
|
4.11 score on a scale
Interval 1.9 to 5.0
|
PRIMARY outcome
Timeframe: Postoperative inpatient stay, which averages approximately two days.Total morphine equivalents (consumed at 4-hour time intervals) received in postoperative inpatient stay.
Outcome measures
| Measure |
Fascia Iliaca Compartment Block
n=59 Participants
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
|
Control
n=60 Participants
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.
|
|---|---|---|
|
Morphine Equivalents Consumed
|
75.3 morphine milliequivalents
Standard Deviation 43.4
|
86.0 morphine milliequivalents
Standard Deviation 55.6
|
SECONDARY outcome
Timeframe: Post operative day oneThe distance the patient is able to walk with physical therapy during their first session
Outcome measures
| Measure |
Fascia Iliaca Compartment Block
n=59 Participants
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
|
Control
n=60 Participants
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.
|
|---|---|---|
|
Walking Distance
|
67.1 Feet
Standard Deviation 59.1
|
68.3 Feet
Standard Deviation 54.0
|
SECONDARY outcome
Timeframe: Post operative day oneTime 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.
Outcome measures
| Measure |
Fascia Iliaca Compartment Block
n=59 Participants
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
|
Control
n=60 Participants
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.
|
|---|---|---|
|
Time to Up-and-go
|
63.7 Seconds
Standard Deviation 62.8
|
66.3 Seconds
Standard Deviation 63.9
|
SECONDARY outcome
Timeframe: Every 6 hours after surgery until completion of inpatient stay, an average of two days days after surgeryTime 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.
Outcome measures
| Measure |
Fascia Iliaca Compartment Block
n=59 Participants
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
|
Control
n=60 Participants
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.
|
|---|---|---|
|
Time to Discharge Readiness
|
35.1 hours
Standard Deviation 12.8
|
35.2 hours
Standard Deviation 11.8
|
Adverse Events
Fascia Iliaca Compartment Block
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place