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

NCT ID: NCT03449680

Last Updated: 2025-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-04

Study Completion Date

2025-03-01

Brief Summary

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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

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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.

Conditions

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Anesthesia, Regional

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
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.

Study Groups

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Femoral Articular Branch Block

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

Group Type EXPERIMENTAL

Femoral Articular Branch Block

Intervention Type 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.

Placebo Block

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

Group Type PLACEBO_COMPARATOR

Placebo Block

Intervention Type PROCEDURE

Subcutaneous injection of 1ml normal sterile saline

Interventions

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Femoral Articular Branch Block

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.

Intervention Type PROCEDURE

Placebo Block

Subcutaneous injection of 1ml normal sterile saline

Intervention Type PROCEDURE

Eligibility Criteria

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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
* Patient refusal of femoral articular branch block
* Revision arthroscopy surgeries
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Women's College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard Brull, MD

Role: PRINCIPAL_INVESTIGATOR

Women's College Hospital, University of Toronto

Daniel Whelan, MD

Role: PRINCIPAL_INVESTIGATOR

Women's College Hospital, University of Toronto

Locations

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Women's College Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 29140962 (View on PubMed)

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.

Reference Type RESULT
PMID: 3577718 (View on PubMed)

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.

Reference Type RESULT
PMID: 16089093 (View on PubMed)

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.

Reference Type RESULT
PMID: 10463728 (View on PubMed)

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.

Reference Type RESULT
PMID: 18929290 (View on PubMed)

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.

Reference Type RESULT
PMID: 20827460 (View on PubMed)

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.

Reference Type RESULT
PMID: 22498045 (View on PubMed)

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.

Reference Type RESULT
PMID: 24284048 (View on PubMed)

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.

Reference Type RESULT
PMID: 26403206 (View on PubMed)

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

Reference Type RESULT
PMID: 18873153 (View on PubMed)

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

Reference Type RESULT
PMID: 5359432 (View on PubMed)

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.

Reference Type RESULT
PMID: 9479711 (View on PubMed)

Other Identifiers

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2016-0119-B

Identifier Type: -

Identifier Source: org_study_id

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