FAB Block vs. Placebo for Hip Arthroplasty Patients

NCT04301687 | Not Yet Recruiting

• 1 other identifier: FAB for Hip Arthroplasty
• Study Type: interventional
• Target: 95
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hip Arthroplasty; Anesthesia, Regional; Femoral Articular Branch Block

Outcome Measures

Primary Outcomes (2)

• Analgesic Consumption

  Postoperative cumulative oral morphine equivalent consumption during the first 24 hours will be the first primary outcome

  24 hours postoperatively

• Quality of Life scores

  Quality of Recovery (QR15) scores at 24 hours will be the second primary outcome.

  24 hours postoperatively

Secondary Outcomes (7)

• Pain Assessment (VAS)

  Up to 48 hours post-operatively

• Analgesic Consumption

  Up to 48 hours following surgery

• Incidence of block-related complications

  Up until one month following nerve block

• Block Success

  4 hours after nerve block has been administered

• Patient Satisfaction with Analgesic Technique

  One month after surgery

Study Arms (2)

Femoral Articular Branch Block

EXPERIMENTAL

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

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

Procedure: Placebo Block

Interventions

Femoral Articular Branch Block 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.

Femoral Articular Branch Block

Placebo Block PROCEDURE

Subcutaneous injection of 1ml normal sterile saline

Placebo Block

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Women's College Hospital: lead

Study Officials

• Richard Brull, MD

  Women's College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Didem Bozak

CONTACT

416-323-6008; didem.bozak@wchospital.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The anesthesiologist performing the nerve block will be aware of group allocation; but a separate anesthesiologist providing intra-operative care will remain blinded. The patient and the research staff collecting outcome data will remain blinded until all data are collected.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized between one of two treatment groups. The intervention of femoral articular branch block or the control group (non-invasive placebo).

Study Record Dates

• First Submitted: January 22, 2020
• First Posted: March 10, 2020
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share