FAB Block vs. Placebo for Hip Arthroplasty Patients

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Procedure: Femoral Articular Branch Block
* Procedure: Placebo Block


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be randomized between one of two treatment groups. The intervention of femoral articular branch block or the control group (non-invasive placebo).
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 |