FAB Block vs. Placebo for Hip Arthroplasty Patients

Not Applicable

Not yet recruiting

• Conditions: Anesthesia, Regional; Hip Arthroplasty; Femoral Articular Branch Block
• Interventions: Procedure: Placebo Block; Procedure: Femoral Articular Branch Block

• Registration Number: NCT04301687
• Lead Sponsor: Women's College Hospital

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.

Study Timeline

• Study First Submitted: 2020-01-22
• Study First Submitted QC: 2020-03-06
• Study First Posted: 2020-03-10
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-03-27
• Study Start: 2025-12
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 95

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Block	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
Femoral Articular Branch Block	Femoral Articular Branch Block	Patients will receive an ultrasound-guided femoral articular branch block with an injection of 20ml of ropivicaine 0.5%

Primary Outcome Measures

Name	Time	Method
Analgesic Consumption	24 hours postoperatively	Postoperative cumulative oral morphine equivalent consumption during the first 24 hours will be the first primary outcome
Quality of Life scores	24 hours postoperatively	Quality of Recovery (QR15) scores at 24 hours will be the second primary outcome.

Secondary Outcome Measures

Name	Time	Method
Pain Assessment (VAS)	Up to 48 hours post-operatively	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
Analgesic Consumption	Up to 48 hours following surgery	Consumption intra-operatively, total in-hospital postoperative consumption, and time to first analgesic request in the first 24 hours, cumulative oral morphine equivalent
Block Success	4 hours after nerve block has been administered	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.
Incidence of block-related complications	Up until one month following nerve block	vascular puncture, hematoma formation, intravascular injection, epidural anesthesia-bilateral sensory block
Patient Satisfaction with Analgesic Technique	One month after surgery	A Patient Diary will be completed to assess overall satisfaction with analgesic technique
Demographic Data	Day 1 - first 24 hours	Patient demographics - There is no scale, just questions asked of the participant.
Incidence of opioid-related side effects	Up until one month following nerve block	nausea, vomiting, pruritus, sedation