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FAB Block vs. Placebo for Hip Arthroplasty Patients

ConditionsHip ArthroplastyAnesthesia, RegionalFemoral Articular Branch Block
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorWomen's College Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

ASA I-III patients

Ages 18-60yrs

BMI ≤ 35 kg/m2

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Femoral Articular Branch Block

    Procedure/Surgery

    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

    Procedure/Surgery

    Subcutaneous injection of 1ml normal sterile saline

Treatment groups

95 Participants
are divided into 2 treatment groups
Group A: Femoral Articular Branch BlockExperimental treatment 1 intervention
Group B: Placebo BlockPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Analgesic Consumption

Postoperative cumulative oral morphine equivalent consumption during the first 24 hours will be the first primary outcome

Time frame
24 hours postoperatively
2

Quality of Life scores

Quality of Recovery (QR15) scores at 24 hours will be the second primary outcome.

Time frame
24 hours postoperatively

Secondary outcomes

1

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

Time frame
Up to 48 hours post-operatively
2

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

Time frame
Up to 48 hours following surgery
3

Incidence of block-related complications

vascular puncture, hematoma formation, intravascular injection, epidural anesthesia-bilateral sensory block

Time frame
Up until one month following nerve block
4

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.

Time frame
4 hours after nerve block has been administered

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Women's College Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: