Hip ArthroplastyNCT04301687
FAB Block vs. Placebo for Hip Arthroplasty Patients
A study testing Femoral Articular Branch Block in people with Hip Arthroplasty and Anesthesia, Regional, run by Women's College Hospital.
Trial summary
Hip arthroplasty surgery can be associated with significant pain. A regional anesthesia technique, the femoral articular branch block (FAB), has recently been proposed to collectively block terminal femoral and accessory obturator nerve branches to the hip joint with a single injection, theoretically blocking most of… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hip Arthroplasty, Anesthesia, Regional, Femoral Articular Branch Block
- What is being tested?
- Femoral Articular Branch Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-III patients
- Ages 18-60yrs
- BMI ≤ 35 kg/m2
Who cannot join
- Preexisting neurological deficits or peripheral neuropathy in the distribution of femoral, obturator, or lateral cutaneous nerves
- Local infection
- Contra-indication to regional anesthesia e.g. bleeding diathesis, coagulopathy
- Chronic pain disorders
- History of use of over 30mg oxycodone or equivalent per day
- Contraindication to a component of multi-modal analgesia
Show all 12Show fewer
- Allergy to local anesthetics
- History of significant psychiatric conditions that may affect patient assessment
- Pregnancy
- Inability to provide informed consent
- Patient refusal of FAB
- Revision arthroscopy surgeries
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Analgesic Efficacy of the Ultrasound-Guided Femoral Articular Branch Block for Ambulatory Hip Arthroplasty: A Randomized-Controlled Trial Secondary IDs:
Hip arthroplasty surgery can be associated with significant pain. A regional anesthesia technique, the femoral articular branch block (FAB), has recently been proposed to collectively block terminal femoral and accessory obturator nerve branches to the hip joint with a single injection, theoretically blocking most of the innervation relevant to hip arthroscopy while sparing the main femoral nerve branches to the quadriceps muscles. The investigators aim to demonstrate the analgesic benefits of FAB. The investigators hypothesize that FAB will reduce opioid consumption and improve postoperative quality of recovery in patients having hip arthroplasty. This is a randomized, controlled, double-blind study and half the patients will be randomized to receive the femoral articular branch block and the other half of patients will be randomized to receive a placebo block. A comparison of pain will be made between both groups.
Read the detailed description
Hip arthroplasty procedure is frequently associated with severe post-operative pain despite the practice of injecting the hip joint with local anesthetics at the end of the procedure and the use of intraoperative opioids. These patients usually receive a spinal anesthetic as well. The ideal analgesic technique that provides adequate pain relief following this procedure has not been established yet.
The femoral articular branch block (FAB) has recently been proposed to collectively block the terminal femoral and accessory obturator nerve branches to the hip joint with a single injection, theoretically blocking most of the innervation relevant to hip arthroscopy while sparing the main femoral nerve branches to the quadriceps muscle. The investigators aim to demonstrate the analgesic benefits of FAB.
- Being tested
- Femoral Articular Branch Block, Placebo Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femoral Articular Branch BlockProcedure or surgery
Slow injection (3mL aliquots) of local anesthetic solution (20ml of Ropivacaine 0.5%) into the fascia above the iliopsoas muscle (located in the groove between the two bony landmarks - (1)anterior inferior iliac crest and (2)iliopubic eminence).This is done by ultrasound guidance.
Placebo BlockProcedure or surgery
Subcutaneous injection of 1ml normal sterile saline
| Study group | Role | What they receive |
|---|---|---|
| Femoral Articular Branch Block | Experimental | Patients will receive an ultrasound-guided femoral articular branch block with an injection of 20ml of ropivicaine 0.5% Receives: Procedure: Femoral Articular Branch Block |
| Placebo Block | Placebo comparator | Patients will receive an ultrasound simulation of the location of a femoral articular branch block , this is to maintain blinding. A subcutaneous injection of 1ml of normal sterile saline will be administered Receives: Procedure: Placebo Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesic Consumption
Postoperative cumulative oral morphine equivalent consumption during the first 24 hours will be the first primary outcome
Measured: 24 hours postoperatively
Quality of Life scores
Quality of Recovery (QR15) scores at 24 hours will be the second primary outcome.
Measured: 24 hours postoperatively
Secondary outcomes (7)
Pain Assessment (VAS)
Visual Analogue Scale(VAS) - Pain:Overall pain assessed at rest and on movement A continuous scale comprised of a 100mm (10cm) horizontal line, anchored by 2 verbal descriptions No Pain to Worst Pain
Measured: Up to 48 hours post-operatively
Analgesic Consumption
Consumption intra-operatively, total in-hospital postoperative consumption, and time to first analgesic request in the first 24 hours, cumulative oral morphine equivalent
Measured: Up to 48 hours following surgery
Incidence of block-related complications
vascular puncture, hematoma formation, intravascular injection, epidural anesthesia-bilateral sensory block
Measured: Up until one month following nerve block
Block Success
Sensory and motor block onset assessment in the 3 nerves involved will be performed every 5 minutes post block procedure up until 30 minutes and then one, two, and four hours postoperatively.
Measured: 4 hours after nerve block has been administered
Patient Satisfaction with Analgesic Technique
A Patient Diary will be completed to assess overall satisfaction with analgesic technique
Measured: One month after surgery
Demographic Data
Patient demographics - There is no scale, just questions asked of the participant.
Measured: Day 1 - first 24 hours
Incidence of opioid-related side effects
nausea, vomiting, pruritus, sedation
Measured: Up until one month following nerve block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study startDec 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip ArthroplastyStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized between one of two treatment groups. The intervention of femoral articular branch block or the control group (non-invasive placebo).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women's College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Brull, MD, Principal investigator, Women's College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04301687
- Sponsor's protocol ID
- FAB for Hip Arthroplasty
- Status last verified
- Apr 2026
- First submitted
- 22 Jan 2020
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Analgesic Efficacy of the Ultrasound-Guided Femoral Articular Branch Block for Ambulatory Hip Arthroplasty: A Randomized-Controlled Trial Secondary IDs:
- ClinicalTrials.gov ID
- NCT04301687
- Acronym / sponsor ID
- FAB for Hip Arthroplasty
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- Women's College HospitalUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 10 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hip arthroplasty surgery can be associated with significant pain. A regional anesthesia technique, the femoral articular branch block (FAB), has recently been proposed to collectively block terminal femoral and accessory obturator nerve branches to the hip joint with a single injection, theoretically blocking most of the innervation relevant to hip arthroscopy while sparing the main femoral nerve branches to the quadriceps muscles. The investigators aim to demonstrate the analgesic benefits of FAB. The investigators hypothesize that FAB will reduce opioid consumption and improve postoperative quality of recovery in patients having hip arthroplasty. This is a randomized, controlled, double-blind study and half the patients will be randomized to receive the femoral articular branch block and the other half of patients will be randomized to receive a placebo block. A comparison of pain will be made between both groups.
Detailed description
Hip arthroplasty procedure is frequently associated with severe post-operative pain despite the practice of injecting the hip joint with local anesthetics at the end of the procedure and the use of intraoperative opioids. These patients usually receive a spinal anesthetic as well. The ideal analgesic technique that provides adequate pain relief following this procedure has not been established yet.
The femoral articular branch block (FAB) has recently been proposed to collectively block the terminal femoral and accessory obturator nerve branches to the hip joint with a single injection, theoretically blocking most of the innervation relevant to hip arthroscopy while sparing the main femoral nerve branches to the quadriceps muscle. The investigators aim to demonstrate the analgesic benefits of FAB.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomized between one of two treatment groups. The intervention of femoral articular branch block or the control group (non-invasive placebo).
| Arm | Type | Receives |
|---|---|---|
| Femoral Articular Branch Block | Experimental | Procedure: Femoral Articular Branch BlockPatients will receive an ultrasound-guided femoral articular branch block with an injection of 20ml of ropivicaine 0.5% |
| Placebo Block | Placebo comparator | Procedure: Placebo BlockPatients will receive an ultrasound simulation of the location of a femoral articular branch block , this is to maintain blinding. A subcutaneous injection of 1ml of normal sterile saline will be administered |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA I-III patients
- Ages 18-60yrs
- BMI ≤ 35 kg/m2
Key exclusion criteria (12 listed)
- Preexisting neurological deficits or peripheral neuropathy in the distribution of femoral, obturator, or lateral cutaneous nerves
- Local infection
- Contra-indication to regional anesthesia e.g. bleeding diathesis, coagulopathy
- Chronic pain disorders
- History of use of over 30mg oxycodone or equivalent per day
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 |
|---|---|---|
| Femoral Articular Branch BlockSlow injection (3mL aliquots) of local anesthetic solution (20ml of Ropivacaine 0.5%) into the fascia above the iliopsoas muscle (located in the groove between the two bony landmarks - (1)anterior inferior iliac crest and (2)iliopubic eminence).This is done by ultrasound guidance. | Procedure or surgery | Femoral Articular Branch Block |
| Placebo BlockSubcutaneous injection of 1ml normal sterile saline | Procedure or surgery | Placebo Block |
Primary outcome
Analgesic Consumption
Time frame: 24 hours postoperatively
Postoperative cumulative oral morphine equivalent consumption during the first 24 hours will be the first primary outcome
Quality of Life scores
Time frame: 24 hours postoperatively
Quality of Recovery (QR15) scores at 24 hours will be the second primary outcome.
7 secondary outcomes
Pain Assessment (VAS)
Time frame: Up to 48 hours post-operatively
Analgesic Consumption
Time frame: Up to 48 hours following surgery
Incidence of block-related complications
Time frame: Up until one month following nerve block
Block Success
Time frame: 4 hours after nerve block has been administered
Patient Satisfaction with Analgesic Technique
Time frame: One month after surgery
Demographic Data
Time frame: Day 1 - first 24 hours
Incidence of opioid-related side effects
Time frame: Up until one month following nerve block
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Richard Brull, MD principal investigator
Women's College Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Femoral Articular Branch Block in people with Hip Arthroplasty and Anesthesia, Regional, run by Women's College Hospital.
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 12 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: opening soon, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Didem Bozak (416-323-6008, didem.bozak@wchospital.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analgesic Consumption (time frame: 24 hours postoperatively). 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?
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 27 Apr 2026.