The Analgesic Efficacy of the Ultrasound-Guided Femoral Articular Branch Block for Ambulatory Hip Arthroscopy
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|ClinicalTrials.gov Identifier: NCT03449680|
Recruitment Status : Recruiting
First Posted : February 28, 2018
Last Update Posted : February 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Anesthesia, Regional||Procedure: Femoral Articular Branch Block Procedure: Placebo Block||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||94 participants|
|Intervention Model:||Parallel Assignment|
|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).|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Masking Description:||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.|
|Official Title:||The Analgesic Efficacy of the Ultrasound-Guided Femoral Articular Branch Block for Ambulatory Hip Arthroscopy: A Randomized-Controlled Trial|
|Actual Study Start Date :||March 4, 2018|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||June 2021|
Experimental: Femoral Articular Branch Block
Patients will receive an ultrasound-guided femoral articular branch block with an injection of 20ml of ropivicaine 0.5%
Procedure: 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.
Placebo Comparator: 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
Procedure: Placebo Block
Subcutaneous injection of 1ml normal sterile saline
- Analgesic Consumption [ Time Frame: 24 hours postoperatively ]Postoperative cumulative oral morphine equivalent consumption during the first 24 hours will be the first primary outcome
- 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.
- Pain Assessment (VAS) [ Time Frame: Up to 48 hours post-operatively ]Visual Analogue Scale(VAS) - Pain:Overall pain assessed at rest and on movement A continuous scale comprised of a 100mm (10cm) horizontal line, anchored by 2 verbal descriptions No Pain to Worst Pain
- Analgesic Consumption [ Time Frame: Up to 48 hours following surgery ]Consumption intra-operatively, total in-hospital postoperative consumption, and time to first analgesic request in the first 24 hours, cumulative oral morphine equivalent
- Side-Effects Complications [ Time Frame: Up until one month following nerve block ]Incidence of any side effects from the all treatments received.
- Block Success [ Time Frame: 4 hours after nerve block has been administered ]Sensory and motor block onset assessment in the 3 nerves involved will be performed every 5 minutes post block procedure up until 30 minutes and then one, two, and four hours postoperatively.
- Patient Satisfaction with Analgesic Technique [ Time Frame: One month after surgery ]A Patient Diary will be completed to assess overall satisfaction with analgesic technique
- Demographic Data [ Time Frame: Day 1 - first 24 hours ]Patient demographics - There is no scale, just questions asked of the participant.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03449680
|Contact: Didem Bozak||416-323-6400 ext email@example.com|
|Women's College Hospital||Recruiting|
|Toronto, Ontario, Canada, M5S 1B2|
|Contact: Didem Bozak 416-323-6400 ext 6008 firstname.lastname@example.org|
|Principal Investigator: Richard Brull, MD,FRCPC|
|Principal Investigator: Daniel Whelan, MD,FRCSC|
|Sub-Investigator: Faraj Abdallah, MD, FRCPC|
|Sub-Investigator: Jas Chahal, MD,FRCSC|
|Sub-Investigator: Tim Dwyer, MD,FRCSC|
|Sub-Investigator: Michael Gofeld, MD,FRCPC|
|Sub-Investigator: Jorge Mejia, MD|
|Sub-Investigator: Arun Prasad, MD, FRCPC|
|Principal Investigator:||Richard Brull, MD||Women's College Hospital, University of Toronto|
|Principal Investigator:||Daniel Whelan, MD||Women's College Hospital, University of Toronto|