Clinical trial NCT03449680: The Analgesic Efficacy of the Ultrasound-Guided Femoral Articular Branch Block for Ambulatory Hip Arthroscopy
Official title: The Analgesic Efficacy of the Ultrasound-Guided Femoral Articular Branch Block for Ambulatory Hip Arthroscopy: A Randomized-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, Regional
Keywords: hip arthroscopy
femoral articular branch block
Lead sponsor: Women's College Hospital
Sponsor class: OTHER
First posted: 2018-02-28
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

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

Primary outcomes:
measure: Analgesic Consumption
timeFrame: 24 hours postoperatively
measure: Quality of Life scores
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Pain Assessment (VAS)
timeFrame: Up to 48 hours post-operatively and at 7-day mark
measure: Analgesic Consumption
timeFrame: Up to 48 hours following surgery
measure: Presence of Block-related complications
timeFrame: Up until one month following nerve block
measure: Incidence of opioid-related side effects
timeFrame: Up until one month following nerve block
measure: Patient Satisfaction with Analgesic Technique
timeFrame: One month after surgery
measure: Demographic Data
timeFrame: Day 1 - first 24 hours
measure: Turn over time
timeFrame: after surgery up to discharge, assessed up to 24 hours
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Women's College Hospital
state: Ontario
Study officials:
affiliation: Women's College Hospital, University of Toronto
name: Richard Brull, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Women's College Hospital, University of Toronto
name: Daniel Whelan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: GARDNER E. The innervation of the hip joint. Anat Rec. 1948 Jul;101(3):353-71. doi: 10.1002/ar.1091010309. No abstract available.
citation: Dee R. Structure and function of hip joint innervation. Ann R Coll Surg Engl. 1969 Dec;45(6):357-74. No abstract available.
citation: 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.