Sensorial and Physiological Mechanism-based Assessments of Perioperative Pain
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- QST
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 21 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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)
干预措施: Clonidine (Drug)
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)
干预措施: Clonidine (Drug)
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)
干预措施: Morphine (Other)
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)
干预措施: Morphine (Other)
结局指标
主要结局
QST
时间窗: 6 months
Evaluate if pre-operative QST can identify if patients will have high pain intensity peri-operatively and at 6 months post-operatively.
次要结局
- Clonidine(6 months)
研究者
Dr. Jean A. Ouellet, MD, FRCSC
Deputy Chief of Staff
Shriners Hospitals for Children