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Clinical Trials/NCT03449680
NCT03449680
Completed
Not Applicable

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

Women's College Hospital1 site in 1 country94 target enrollmentMarch 4, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anesthesia, Regional
Sponsor
Women's College Hospital
Enrollment
94
Locations
1
Primary Endpoint
Quality of Life scores
Status
Completed
Last Updated
last year

Overview

Brief Summary

Hip arthroscopy 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 arthroscopy. 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 arthroscopy is a surgical technique that is gaining popularity for its diagnostic and therapeutic role in the management of adult hip pain. This 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. The ideal analgesic technique that provides adequate pain relief following this procedure has not been established yet. There is evidence to suggest that a femoral nerve block (FNB) may provide clinically meaningful analgesia. The investigators have examined the benefits of FNB both retrospectively and prospectively in hip arthroscopy patients at Women's College Hospital (WCH). Both of our studies suggested modest benefits of the FNB in terms of controlling post-operative pain and reducing opioid consumption. However the majority of patients continued to experience moderate to severe post-operative pain and required significant amounts of opioid analgesics in the Peri-Anesthesia Unit (PAU), despite receiving the FNB. Another regional anesthesia technique, 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.

Registry
clinicaltrials.gov
Start Date
March 4, 2018
End Date
March 1, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • American Society of Anesthesiologists (ASA) physical classification system, ASA I-III patients
  • 18 - 60 years of age
  • Body Mass Index (BMI) \<35 kg/m2

Exclusion Criteria

  • Pre-existing 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 using over 30mg of oxycodone or equivalent per day
  • Contraindication to a component of multi-modal analgesia
  • Allergy to local anesthesia
  • History of significant psychiatric conditions that may affect patient assessment
  • Pregnancy
  • Inability to provide informed consent

Outcomes

Primary Outcomes

Quality of Life scores

Time Frame: 24 hours postoperatively

Quality of Recovery (QR15) scores at 24 hours will be the second primary outcome. QR15 is a measurement of quality of recovery after surgery and anesthesia that has been psychometrically tested and validated. Reporting of outcome measures on a scale of 0 to 10 (0=None of the time and 10=All of the time). There are a total of 40 items/questions.

Analgesic Consumption

Time Frame: 24 hours postoperatively

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

Secondary Outcomes

  • Presence of Block-related complications(Up until one month following nerve block)
  • Analgesic Consumption(Up to 48 hours following surgery)
  • Incidence of opioid-related side effects(Up until one month following nerve block)
  • Pain Assessment (VAS)(Up to 48 hours post-operatively and at 7-day mark)
  • Patient Satisfaction with Analgesic Technique(One month after surgery)
  • Turn over time(after surgery up to discharge, assessed up to 24 hours)
  • Demographic Data(Day 1 - first 24 hours)

Study Sites (1)

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