Sensorial and Physiological Mechanism-based Assessments of Perioperative Pain

NCT03537612 | Terminated Phase 3 DMC

• 1 other identifier: CAN1701
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Scoliosis

Keywords

Post-operative pain

Outcome Measures

Primary Outcomes (1)

• QST

  Evaluate if pre-operative QST can identify if patients will have high pain intensity peri-operatively and at 6 months post-operatively.

  6 months

Secondary Outcomes (1)

• Clonidine

  6 months

Other Outcomes (1)

• 3D Images 3D Biomechanical Alterations

  6 months

Study Arms (4)

Opt-Clonidine

EXPERIMENTAL

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

Sub-opt-Clonidine

EXPERIMENTAL

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

Opt-Morphine

ACTIVE COMPARATOR

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

Sub-opt-Morphine

ACTIVE COMPARATOR

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

Interventions

Clonidine DRUG

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)

Opt-Clonidine; Sub-opt-Clonidine

Morphine OTHER

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)

Opt-Morphine; Sub-opt-Morphine

Eligibility Criteria

• Age: 10 Years - 21 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Jean A. Ouellet, MD, FRCSC: lead

Study Sites (1)

Shriners Hospitals for Children - Canada

Montreal, Quebec, H4A 0A9, Canada

Location

MeSH Terms

Conditions

Scoliosis; Pain, Postoperative

Interventions

Clonidine; Morphine

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Jean A Ouellet, MD

  Shriners Hospital for Children - Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Chief of Staff

Model Details: Double-blind, randomized

Study Record Dates

• First Submitted: May 15, 2018
• First Posted: May 25, 2018
• Study Start: June 22, 2018
• Primary Completion: April 5, 2022
• Study Completion: April 5, 2022
• Last Updated: November 22, 2023

Record last verified: 2023-11

Locations

CA (1)