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Sensorial and Physiological Mechanism-based Assessments of Perioperative Pain (RCT)

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ClinicalTrials.gov Identifier: NCT03537612
Recruitment Status : Recruiting
First Posted : May 25, 2018
Last Update Posted : September 19, 2019
Sponsor:
Collaborators:
Catherine Ferland
Pablo Ingelmo
Information provided by (Responsible Party):
Dr. Jean A. Ouellet, MD, FRCSC, Shriners Hospitals for Children

Tracking Information
First Submitted Date  ICMJE May 15, 2018
First Posted Date  ICMJE May 25, 2018
Last Update Posted Date September 19, 2019
Actual Study Start Date  ICMJE June 22, 2018
Estimated Primary Completion Date June 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2018)
QST [ Time Frame: 6 months ]
Evaluate if pre-operative QST can identify if patients will have high pain intensity peri-operatively and at 6 months post-operatively.
Original Primary Outcome Measures  ICMJE
 (submitted: May 15, 2018)
QST [ Time Frame: 6 months ]
Evaluate if pre-operative QST can identify if patients will have high pain intensity peri-operatively and at 6 months post-operatively
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2018)
Clonidine [ Time Frame: 6 months ]
Peri-operative use of an alpha-2 adrenergic receptor agonist enhances the efficacy of the descending inhibitory system of patients with sub-optimal CPM efficacy before surgery by decreasing pain after surgery.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2018)
Clonidine [ Time Frame: 6 months ]
peri-operative use of an alpha-2 adrenergic receptor agonist enhances the efficacy of the descending inhibitory system of patients with sub-optimal CPM efficacy before surgery by decreasing pain after surgery
Current Other Pre-specified Outcome Measures
 (submitted: July 11, 2018)
3D Images 3D Biomechanical Alterations [ Time Frame: 6 months ]
Evaluate the potential biomechanical alterations in 3D related to pain in children reporting presence of back pain pre and post spine surgery.
Original Other Pre-specified Outcome Measures
 (submitted: May 15, 2018)
3D Images 3D Biomechanical Alterations [ Time Frame: 6 months ]
Evaluate the potential biomechanical alterations in 3D related to pain in children reporting presence of back pain pre and post spine surgery
 
Descriptive Information
Brief Title  ICMJE Sensorial and Physiological Mechanism-based Assessments of Perioperative Pain
Official Title  ICMJE Sensorial and Physiological Mechanism-based Assessments of Perioperative Pain
Brief Summary The overall goal of this proposal is to determine if quantitative sensory testing (QST) assessing pain modulation can be used as a clinical tool to optimize perioperative pain management. The central hypothesis is that the identification of patient's sensory pain profile allows personalizing therapeutic approaches to improve individualized pain management and thus prevents pain chronicity.
Detailed Description

The primary objective of this study is to evaluate if pre-operative QST can identify if patients will have high pain intensity peri-operatively and at 6 months post-operatively. Evaluation of the intensity and chronicity of pain and the function of the descending inhibitory system through a short QST procedure before surgery and six months after surgery will be carried out. In addition, evaluation of the patient's physical and emotional functioning, and exploration of the potential biological underlying mechanisms will also be assessed at the same time points.

The secondary objective of this study is to determine if the peri-operative use of an alpha-2 adrenergic receptor agonist enhances the efficacy of the descending inhibitory system of patients with sub-optimal CPM efficacy before surgery by decreasing pain after surgery. Consequently, this pharmacological intervention may also reduce the incidence of acute and chronic pain after surgery. Evaluation of the pain intensity and the function of the descending inhibitory system through a short QST procedure six weeks after surgery and six months after surgery in patients receiving Clonidine or placebo during the perioperative period will be done. In addition, evaluation of the patient's physical and emotional functioning, and exploration the potential biological underlying mechanisms at the same time points will be assessed.

Lastly, evaluation of potential biomechanical alterations in 3D related to pain in children reporting presence of back pain pre and post spine surgery will be looked at.

The hypothesis is that patients undergoing spine surgery with poor inhibitory pain response will have less pain in the immediate and long-term period when treated prophylactically with Clonidine in the perioperative period.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Double-blind, randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Scoliosis
Intervention  ICMJE
  • Drug: Clonidine
    Intrathecal Clonidine 1 mcg/kg (up to 75 mcg) immediatey post-op; 100 mcg capsule TID Post op day 1-5 (liquid version available if subject cannot swallow capsule)
  • Other: Morphine
    Intrathecal spinal morphine (5 mcg / kg) immediatey post-op; Placebo capsule TID Post op day 1-5 (liquid version available if subject cannot swallow capsule)
Study Arms  ICMJE
  • Experimental: Opt-Clonidine
    Intrathecal Clonidine 1 mcg/kg (up to 75 mcg) immediately post-op; Clonidine pill TID Post-op Day 1-5 (liquid version available if subject cannot swallow capsule)
    Intervention: Drug: Clonidine
  • Experimental: Sub-opt-Clonidine
    Intrathecal Clonidine 1 mcg/kg (up to 75 mcg) immediately post-op; Clonidine pill TID Post-op Day 1-5 (liquid version available if subject cannot swallow capsule)
    Intervention: Drug: Clonidine
  • Active Comparator: Opt-Morphine
    Intrathecal spinal morphine (5 mcg / kg) immediately post-op; Placebo pill TID Post-op Day 1-5 (liquid version available if subject cannot swallow capsule)
    Intervention: Other: Morphine
  • Active Comparator: Sub-opt-Morphine
    Intrathecal spinal morphine (5 mcg / kg) immediately post-op; Placebo pill TID Post-op Day 1-5 (liquid version available if subject cannot swallow capsule)
    Intervention: Other: Morphine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 15, 2018)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date June 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Females* aged between 10 and 21 years old
  • Scheduled to undergo anterior or posterior spinal fusion surgery for AIS with instrumentation
  • Ability to adequately understand and respond to outcome measures
  • No previous major orthopedic surgery
  • Any ethnic background

Exclusion Criteria:

  • Children with history of allergies to Clonidine or it's excipients in either injection or tablet formulation (see respective monograph)
  • Children with history of galactose intolerance
  • Children with history of myocardial disease, arrhythmias, cerebrovascular disease, Raynaud's/Thromboangiitis obliterans or chronic renal failure diagnosis based on history and physical
  • Children taking anti-hypertensive agents (diuretics, vasodilators, beta-blockers, ace-inhibitors)
  • History of depression
  • Inability of the child to speak English or French
  • Diagnosed with developmental delay that would interfere with understanding the questions being asked (autism, mental retardation)
  • Children with major chronic medical conditions (ASA status III or higher)
  • Pregnancy excluded by an in hospital testing the night before surgery
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 10 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jean A Ouellet, MD 514-825-1069 jaouellet@gmail.com
Contact: Dee-Anne Naylor 514-842-4464 ext 1259 danaylor@shrinenet.org
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03537612
Other Study ID Numbers  ICMJE CAN1701
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Jean A. Ouellet, MD, FRCSC, Shriners Hospitals for Children
Study Sponsor  ICMJE Dr. Jean A. Ouellet, MD, FRCSC
Collaborators  ICMJE
  • Catherine Ferland
  • Pablo Ingelmo
Investigators  ICMJE
Principal Investigator: Jean A Ouellet, MD Shriners Hospital for Children - Canada
PRS Account Shriners Hospitals for Children
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP