Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 10 of 57 for:    Recruiting, Not yet recruiting, Available Studies | Arthroscopy

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03449680
Recruitment Status : Recruiting
First Posted : February 28, 2018
Last Update Posted : February 18, 2019
Sponsor:
Information provided by (Responsible Party):
Women's College Hospital

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.

Condition or disease Intervention/treatment Phase
Anesthesia, Regional Procedure: Femoral Articular Branch Block Procedure: Placebo Block Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 94 participants
Allocation: Randomized
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.
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Analgesic Consumption [ Time Frame: 24 hours postoperatively ]
    Postoperative cumulative oral morphine equivalent consumption during the first 24 hours will be the first primary outcome

  2. 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.



Secondary Outcome Measures :
  1. 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

  2. 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

  3. Side-Effects Complications [ Time Frame: Up until one month following nerve block ]
    Incidence of any side effects from the all treatments received.

  4. 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.

  5. Patient Satisfaction with Analgesic Technique [ Time Frame: One month after surgery ]
    A Patient Diary will be completed to assess overall satisfaction with analgesic technique

  6. Demographic Data [ Time Frame: Day 1 - first 24 hours ]
    Patient demographics - There is no scale, just questions asked of the participant.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Didem Bozak 416-323-6400 ext 6008 didem.bozak@wchospital.ca

Locations
Layout table for location information
Canada, Ontario
Women's College Hospital Recruiting
Toronto, Ontario, Canada, M5S 1B2
Contact: Didem Bozak    416-323-6400 ext 6008    didem.bozak@wchospital.ca   
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         
Sponsors and Collaborators
Women's College Hospital
Investigators
Layout table for investigator information
Principal Investigator: Richard Brull, MD Women's College Hospital, University of Toronto
Principal Investigator: Daniel Whelan, MD Women's College Hospital, University of Toronto

Publications of Results:

Other Publications:
Layout table for additonal information
Responsible Party: Women's College Hospital
ClinicalTrials.gov Identifier: NCT03449680     History of Changes
Other Study ID Numbers: 2016-0119-B
First Posted: February 28, 2018    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Women's College Hospital:
hip arthroscopy
femoral articular branch block

Additional relevant MeSH terms:
Layout table for MeSH terms
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs