FAB Block vs. Placebo for Hip Arthroplasty Patients

Hip Arthroplasty Clinical Trial

Official title:

The Analgesic Efficacy of the Ultrasound-Guided Femoral Articular Branch Block for Ambulatory Hip Arthroplasty: A Randomized-Controlled Trial Secondary IDs:

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04301687
• Other study ID #: FAB for Hip Arthroplasty
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2024
• Est. completion date: December 2025

Study information

• Verified date: April 2023
• Source: Women's College Hospital
• Contact: Didem Bozak
• Phone: 416-323-6008
• Email: didem.bozak[@]wchospital.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 95
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, Regional
• Femoral Articular Branch Block
• Hip Arthroplasty

Intervention

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 Block
Subcutaneous injection of 1ml normal sterile saline

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Women's College Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analgesic Consumption	Postoperative cumulative oral morphine equivalent consumption during the first 24 hours will be the first primary outcome	24 hours postoperatively
Primary	Quality of Life scores	Quality of Recovery (QR15) scores at 24 hours will be the second primary outcome.	24 hours postoperatively
Secondary	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
Secondary	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
Secondary	Incidence of block-related complications	vascular puncture, hematoma formation, intravascular injection, epidural anesthesia-bilateral sensory block	Up until one month following nerve block
Secondary	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
Secondary	Patient Satisfaction with Analgesic Technique	A Patient Diary will be completed to assess overall satisfaction with analgesic technique	One month after surgery
Secondary	Demographic Data	Patient demographics - There is no scale, just questions asked of the participant.	Day 1 - first 24 hours
Secondary	Incidence of opioid-related side effects	nausea, vomiting, pruritus, sedation	Up until one month following nerve block