Arthritis of HipPhase 4NCT03375112
Fascia Iliaca Blocks for Pain Control After Total Hip Arthroplasty
A Phase 4 study testing Fascia iliaca compartment block and Bupivacaine in people with Arthritis of Hip, run by Henry Ford Health System at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis of Hip
- What is being tested?
- Fascia iliaca compartment block and Bupivacaine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2017to 1 Oct 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over the age of 18
- Scheduled for total hip arthroplasty at Henry Ford Hospital
- Epidural anesthesia during surgery
Who cannot join
- Pregnancy
- Known intolerance to local anesthetic or narcotics
- Revision hip surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pain Control After Total Hip Arthroplasty: A Randomized Trial Determining Efficacy of Fascia Iliaca Compartment Blocks in the Immediate Post-Operative Period
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.
Read the 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.
- Conditions
- Arthritis of Hip
- Being tested
- Fascia iliaca compartment block, Placebo, Bupivacaine
- Keywords
- Total Hip Arthroplasty, Fascia Iliaca, Nerve Block, Pain Control
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fascia iliaca compartment blockProcedure or surgery
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.
PlaceboDrug
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.
BupivacaineDrug
A one time dose of 40 milliliters of 0.5% bupivacaine will be injected into the fascia iliaca compartment
| Study group | Role | What they receive |
|---|---|---|
| Fascia Iliaca Compartment Block | Experimental | A Fascia Iliaca Compartment Block will be administered in the block room. Receives: Procedure: Fascia iliaca compartment block; Drug: Bupivacaine |
| 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Postoperative inpatient stay, which averages approximately two days.
Secondary outcomes (3)
Walking Distance
The distance the patient is able to walk with physical therapy during their first session
Measured: 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.
Measured: 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.
Measured: Every 6 hours after surgery until completion of inpatient stay, an average of two days days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2017
- Study start31 Jul 2017
- Primary completion1 Oct 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arthritis of HipStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Charters, MD, Henry Ford Health System
- Investigators
- Michael Charters, MD, Principal investigator, Henry Ford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03375112
- Sponsor's protocol ID
- FICB01
- Status last verified
- Sep 2023
- First submitted
- 22 Mar 2017
- Last updated
- 10 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32222267
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Control After Total Hip Arthroplasty: A Randomized Trial Determining Efficacy of Fascia Iliaca Compartment Blocks in the Immediate Post-Operative Period
- ClinicalTrials.gov ID
- NCT03375112
- Acronym / sponsor ID
- FICB01
- Conditions
- Arthritis of Hip
- Keywords
- Total Hip Arthroplasty, Fascia Iliaca, Nerve Block, Pain Control
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 31 Jul 2017 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 15 Dec 2017 (actual)
- Results
- Posted 10 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fascia Iliaca Compartment Block | Experimental | Procedure: Fascia iliaca compartment block, Drug: BupivacaineA Fascia Iliaca Compartment Block will be administered in the block room. |
| Control | Placebo comparator | Drug: PlaceboThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients over the age of 18
- Scheduled for total hip arthroplasty at Henry Ford Hospital
- Epidural anesthesia during surgery
Key exclusion criteria (3 listed)
- Pregnancy
- Known intolerance to local anesthetic or narcotics
- Revision hip surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fascia iliaca compartment blockThe 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. | Procedure or surgery | Fascia Iliaca Compartment Block |
| PlaceboThe 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. | Drug | Control |
| BupivacaineA one time dose of 40 milliliters of 0.5% bupivacaine will be injected into the fascia iliaca compartment | Drug | Fascia Iliaca Compartment Block |
Primary outcome
Averaged Pain Score
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.
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
Time frame: Postoperative inpatient stay, which averages approximately two days.
Total morphine equivalents (consumed at 4-hour time intervals) received in postoperative inpatient stay.
3 secondary outcomes
Walking Distance
Time frame: Post operative day one
Time to Up-and-go
Time frame: Post operative day one
Time to Discharge Readiness
Time frame: Every 6 hours after surgery until completion of inpatient stay, an average of two days days after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32222267Bober 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Charters, MD principal investigator
Henry Ford Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fascia iliaca compartment block and Bupivacaine in people with Arthritis of Hip, run by Henry Ford Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Averaged Pain Score (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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03375112, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.