ScoliosisPhase 3RCTNCT03537612
Sensorial and Physiological Mechanism-based Assessments of Perioperative Pain
A Phase 3 study testing Clonidine and Morphine in people with Scoliosis, run by Dr. Jean A. Ouellet, MD, FRCSC at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 21 years, women only
- Conditions the study is for
- Scoliosis
- What is being tested?
- Clonidine and Morphine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 22 Jun 2018to 5 Apr 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 21 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Shriners Hospitals for Children - Canada
Montreal, Quebec, H4A 0A9
About this study
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.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClonidineDrug
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)
MorphineOther
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 group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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) Receives: 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) Receives: Other: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
QST
Evaluate if pre-operative QST can identify if patients will have high pain intensity peri-operatively and at 6 months post-operatively.
Measured: 6 months
Secondary outcomes (1)
Clonidine
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2018
- Study start22 Jun 2018
- Primary completion5 Apr 2022
- Study completion5 Apr 2022
Why it stopped: Do to our inability to meet recruitment targets - Sponsor stopped funding. Looking for new sponsor and protocol modifications
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScoliosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, randomized
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Jean A. Ouellet, MD, FRCSC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Jean A. Ouellet, MD, FRCSC, Shriners Hospitals for Children
- Investigators
- Jean A Ouellet, MD, Principal investigator, Shriners Hospital for Children - Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03537612
- Sponsor's protocol ID
- CAN1701
- Acronym
- RCT
- Status last verified
- Nov 2023
- First submitted
- 15 May 2018
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensorial and Physiological Mechanism-based Assessments of Perioperative Pain
- ClinicalTrials.gov ID
- NCT03537612
- Acronym / sponsor ID
- RCT / CAN1701
- Conditions
- Scoliosis
- Keywords
- Post-operative pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Do to our inability to meet recruitment targets - Sponsor stopped funding. Looking for new sponsor and protocol modifications
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Dr. Jean A. Ouellet, MD, FRCSCUniversity, hospital or other
- Study start
- 22 Jun 2018 (actual)
- Primary completion
- 5 Apr 2022 (actual)
- Study completion
- 5 Apr 2022 (actual)
- First posted
- 25 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Double-blind, randomized
| Arm | Type | Receives |
|---|---|---|
| Opt-Clonidine | Experimental | Drug: ClonidineIntrathecal 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) |
| Sub-opt-Clonidine | Experimental | Drug: ClonidineIntrathecal 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) |
| Opt-Morphine | Active comparator | Other: MorphineIntrathecal spinal morphine (5 mcg / kg) immediately post-op; Placebo pill TID Post-op Day 1-5 (liquid version available if subject cannot swallow capsule) |
| Sub-opt-Morphine | Active comparator | Other: MorphineIntrathecal spinal morphine (5 mcg / kg) immediately post-op; Placebo pill TID Post-op Day 1-5 (liquid version available if subject cannot swallow capsule) |
Who may qualify
- Ages
- 10 to 21 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClonidineIntrathecal 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) | Drug | Opt-Clonidine, Sub-opt-Clonidine |
| MorphineIntrathecal spinal morphine (5 mcg / kg) immediatey post-op; Placebo capsule TID Post op day 1-5 (liquid version available if subject cannot swallow capsule) | Other | Opt-Morphine, Sub-opt-Morphine |
Primary outcome
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.
1 secondary outcome
Clonidine
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Do to our inability to meet recruitment targets - Sponsor stopped funding. Looking for new sponsor and protocol modifications). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean A Ouellet, MD principal investigator
Shriners Hospital for Children - Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Clonidine and Morphine in people with Scoliosis, run by Dr. Jean A. Ouellet, MD, FRCSC at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Do to our inability to meet recruitment targets - Sponsor stopped funding. Looking for new sponsor and protocol modifications). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QST (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.