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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03537612
Recruitment Status : Suspended (Do to our inability to meet recruitment targets - Sponsor stopped funding. Looking for new sponsor and protocol modifications)
First Posted : May 25, 2018
Last Update Posted : December 9, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Jean A. Ouellet, MD, FRCSC, Shriners Hospitals for Children

Study Description
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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.

Condition or disease Intervention/treatment Phase
Scoliosis Drug: Clonidine Other: Morphine Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-blind, randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sensorial and Physiological Mechanism-based Assessments of Perioperative Pain
Actual Study Start Date : June 22, 2018
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis

Arms and Interventions
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Arm Intervention/treatment
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)
 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)
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)
 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)
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)
 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)
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)
 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)


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.


Eligibility Criteria
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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.


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Ages Eligible for Study:   10 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT03537612


Locations
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Canada, Quebec
Shriners Hospitals for Children - Canada
Montréal, Quebec, Canada, H4A 0A9
Sponsors and Collaborators
Dr. Jean A. Ouellet, MD, FRCSC
Investigators
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Principal Investigator: Jean A Ouellet, MD Shriners Hospital for Children - Canada
  Study Documents (Full-Text)

Documents provided by Dr. Jean A. Ouellet, MD, FRCSC, Shriners Hospitals for Children:
Study Protocol and Statistical Analysis Plan  [PDF] April 17, 2018

More Information
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Responsible Party: Dr. Jean A. Ouellet, MD, FRCSC, Deputy Chief of Staff, Shriners Hospitals for Children
ClinicalTrials.gov Identifier: NCT03537612    
Other Study ID Numbers: CAN1701
First Posted: May 25, 2018    Key Record Dates
Last Update Posted: December 9, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Jean A. Ouellet, MD, FRCSC, Shriners Hospitals for Children:
Post-operative pain
Additional relevant MeSH terms:
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Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Clonidine
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action