Clinical trial NCT04301687: FAB Block vs. Placebo for Hip Arthroplasty Patients
Official title: The Analgesic Efficacy of the Ultrasound-Guided Femoral Articular Branch Block for Ambulatory Hip Arthroplasty: A Randomized-Controlled Trial Secondary IDs:
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hip Arthroplasty
Anesthesia, Regional
Femoral Articular Branch Block
Lead sponsor: Women's College Hospital
Sponsor class: OTHER
First posted: 2020-03-10
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Analgesic Consumption
timeFrame: 24 hours postoperatively
measure: Quality of Life scores
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Pain Assessment (VAS)
timeFrame: Up to 48 hours post-operatively
measure: Analgesic Consumption
timeFrame: Up to 48 hours following surgery
measure: Incidence of block-related complications
timeFrame: Up until one month following nerve block
measure: Block Success
timeFrame: 4 hours after nerve block has been administered
measure: Patient Satisfaction with Analgesic Technique
timeFrame: One month after surgery
measure: Demographic Data
timeFrame: Day 1 - first 24 hours
measure: Incidence of opioid-related side effects
timeFrame: Up until one month following nerve block
Other outcomes:
Locations:
Study officials:
affiliation: Women's College Hospital
name: Richard Brull, MD
role: PRINCIPAL_INVESTIGATOR
References: