The Analgesic Efficacy of the Ultrasound-Guided Femoral Articular Branch Block for Ambulatory Hip Arthroscopy

NCT03449680 | Completed

• 1 other identifier: 2016-0119-B
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia, Regional

Keywords

hip arthroscopy; femoral articular branch block

Outcome Measures

Primary Outcomes (2)

• 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. 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.

  24 hours postoperatively

Secondary Outcomes (7)

• Pain Assessment (VAS)

  Up to 48 hours post-operatively and at 7-day mark

• Analgesic Consumption

  Up to 48 hours following surgery

• Presence of Block-related complications

  Up until one month following nerve block

• Incidence of opioid-related side effects

  Up until one month following nerve block

• Patient Satisfaction with Analgesic Technique

  One month after surgery

Study Arms (2)

Femoral Articular Branch Block

EXPERIMENTAL

Patients will receive an ultrasound-guided femoral articular branch block with an injection of 20ml of ropivicaine 0.5%

Procedure: Femoral Articular Branch Block

Placebo Block

PLACEBO COMPARATOR

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

Interventions

Femoral Articular Branch Block PROCEDURE

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.

Femoral Articular Branch Block

Placebo Block PROCEDURE

Subcutaneous injection of 1ml normal sterile saline

Placebo Block

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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
• Patient refusal of femoral articular branch block
• Revision arthroscopy surgeries

Sponsors & Collaborators

• Women's College Hospital: lead

Study Sites (1)

Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

Location

Related Publications (12)

• Short AJ, Barnett JJG, Gofeld M, Baig E, Lam K, Agur AMR, Peng PWH. Anatomic Study of Innervation of the Anterior Hip Capsule: Implication for Image-Guided Intervention. Reg Anesth Pain Med. 2018 Feb;43(2):186-192. doi: 10.1097/AAP.0000000000000701.

  PMID: 29140962 BACKGROUND

• Suzuki S, Awaya G, Okada Y, Maekawa M, Ikeda T, Tada H. Arthroscopic diagnosis of ruptured acetabular labrum. Acta Orthop Scand. 1986 Dec;57(6):513-5. doi: 10.3109/17453678609014781.

  PMID: 3577718 RESULT

• Larson CM, Swaringen J, Morrison G. A review of hip arthroscopy and its role in the management of adult hip pain. Iowa Orthop J. 2005;25:172-9.

  PMID: 16089093 RESULT

• Baber YF, Robinson AH, Villar RN. Is diagnostic arthroscopy of the hip worthwhile? A prospective review of 328 adults investigated for hip pain. J Bone Joint Surg Br. 1999 Jul;81(4):600-3. doi: 10.1302/0301-620x.81b4.8803.

  PMID: 10463728 RESULT

• Lee EM, Murphy KP, Ben-David B. Postoperative analgesia for hip arthroscopy: combined L1 and L2 paravertebral blocks. J Clin Anesth. 2008 Sep;20(6):462-5. doi: 10.1016/j.jclinane.2008.04.012.

  PMID: 18929290 RESULT

• Baker JF, Byrne DP, Hunter K, Mulhall KJ. Post-operative opiate requirements after hip arthroscopy. Knee Surg Sports Traumatol Arthrosc. 2011 Aug;19(8):1399-402. doi: 10.1007/s00167-010-1248-4. Epub 2010 Sep 9.

  PMID: 20827460 RESULT

• Ward JP, Albert DB, Altman R, Goldstein RY, Cuff G, Youm T. Are femoral nerve blocks effective for early postoperative pain management after hip arthroscopy? Arthroscopy. 2012 Aug;28(8):1064-9. doi: 10.1016/j.arthro.2012.01.003. Epub 2012 Apr 11.

  PMID: 22498045 RESULT

• Dold AP, Murnaghan L, Xing J, Abdallah FW, Brull R, Whelan DB. Preoperative femoral nerve block in hip arthroscopic surgery: a retrospective review of 108 consecutive cases. Am J Sports Med. 2014 Jan;42(1):144-9. doi: 10.1177/0363546513510392. Epub 2013 Nov 27.

  PMID: 24284048 RESULT

• Xing JG, Abdallah FW, Brull R, Oldfield S, Dold A, Murnaghan ML, Whelan DB. Preoperative Femoral Nerve Block for Hip Arthroscopy: A Randomized, Triple-Masked Controlled Trial. Am J Sports Med. 2015 Nov;43(11):2680-7. doi: 10.1177/0363546515602468. Epub 2015 Sep 24.

  PMID: 26403206 RESULT

• GARDNER E. The innervation of the hip joint. Anat Rec. 1948 Jul;101(3):353-71. doi: 10.1002/ar.1091010309. No abstract available.

  PMID: 18873153 RESULT

• Dee R. Structure and function of hip joint innervation. Ann R Coll Surg Engl. 1969 Dec;45(6):357-74. No abstract available.

  PMID: 5359432 RESULT

• Birnbaum K, Prescher A, Hessler S, Heller KD. The sensory innervation of the hip joint--an anatomical study. Surg Radiol Anat. 1997;19(6):371-5. doi: 10.1007/BF01628504.

  PMID: 9479711 RESULT

Study Officials

• Richard Brull, MD

  Women's College Hospital, University of Toronto

  PRINCIPAL INVESTIGATOR

• Daniel Whelan, MD

  Women's College Hospital, University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The anesthesiologist performing the nerve block will be aware of group allocation; but a separate anesthesiologist providing intra-operative care will remain blinded. The patient and the research staff collecting outcome data will remain blinded until all data are collected.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized between one of two treatment groups. The intervention of femoral articular branch block or the control group (non-invasive placebo).

Study Record Dates

• First Submitted: September 1, 2017
• First Posted: February 28, 2018
• Study Start: March 4, 2018
• Primary Completion: January 31, 2025
• Study Completion: March 1, 2025
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)