FAB Block vs. Placebo for Hip Arthroplasty Patients

NCT ID: NCT04301687

Last Updated: 2025-03-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 95 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2026-12-31

Brief 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 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.

Conditions

Hip Arthroplasty; Anesthesia, Regional; Femoral Articular Branch Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Femoral Articular Branch Block

Patients will receive an ultrasound-guided femoral articular branch block with an injection of 20ml of ropivicaine 0.5%

Group Type: EXPERIMENTAL

Femoral Articular Branch Block

Intervention Type: PROCEDURE

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 Block

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

Group Type: PLACEBO_COMPARATOR

Placebo Block

Intervention Type: PROCEDURE

Subcutaneous injection of 1ml normal sterile saline

Interventions

Femoral Articular Branch Block

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.

Intervention Type: PROCEDURE

Placebo Block

Subcutaneous injection of 1ml normal sterile saline

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• ASA I-III patients
• Ages 18-60yrs
• BMI ≤ 35 kg/m2

Exclusion Criteria

• 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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Women's College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Brull, MD

Role: PRINCIPAL_INVESTIGATOR

Women's College Hospital

Central Contacts

Didem Bozak

Role: CONTACT

didem.bozak@wchospital.ca

416-323-6008

Other Identifiers

FAB for Hip Arthroplasty

Identifier Type: -

Identifier Source: org_study_id