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FAB Block vs. Placebo for Hip Arthroplasty Patients

W

Women's College Hospital

Status

Not yet enrolling

Conditions

Anesthesia, Regional
Femoral Articular Branch Block
Hip Arthroplasty

Treatments

Procedure: Placebo Block
Procedure: Femoral Articular Branch Block

Study type

Interventional

Funder types

Other

Identifiers

NCT04301687
FAB for Hip Arthroplasty

Details and patient eligibility

About

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.

Full 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.

Enrollment

95 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

95 participants in 2 patient groups, including a placebo group

Femoral Articular Branch Block
Experimental group
Description:
Patients will receive an ultrasound-guided femoral articular branch block with an injection of 20ml of ropivicaine 0.5%
Treatment:
Procedure: Femoral Articular Branch Block
Placebo Block
Placebo Comparator group
Description:
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
Treatment:
Procedure: Placebo Block

Trial contacts and locations

0

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Central trial contact

Didem Bozak

Data sourced from clinicaltrials.gov

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