FAB Block vs. Placebo for Hip Arthroplasty Patients

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hip Arthroplasty; Anesthesia, Regional; Femoral Articular Branch Block
• Intervention / Treatment: Procedure: Femoral Articular Branch Block; Procedure: Placebo Block

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 Type: Interventional
• Enrollment (Anticipated): 95
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Femoral Articular Branch Block; Patients will receive an ultrasound-guided femoral articular branch block with an injection of 20ml of ropivicaine 0.5%	Procedure: 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.
Placebo Comparator: 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	Procedure: Placebo Block; Subcutaneous injection of 1ml normal sterile saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Up to 48 hours following surgery
Incidence of block-related complications	vascular puncture, hematoma formation, intravascular injection, epidural anesthesia-bilateral sensory block	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.	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	One month after surgery
Demographic Data	Patient demographics - There is no scale, just questions asked of the participant.	Day 1 - first 24 hours
Incidence of opioid-related side effects	nausea, vomiting, pruritus, sedation	Up until one month following nerve block

Collaborators and Investigators

• Sponsor: Women's College Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2024
• Primary Completion (Anticipated): December 1, 2025
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: January 22, 2020
• First Submitted That Met QC Criteria: March 6, 2020
• First Posted (Actual): March 10, 2020

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: FAB for Hip Arthroplasty

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No