A Multicenter Prospective Randomized Double-blind Placebo Controlled Trial Assessing the Effect of Perioperative Pregabalin on the Incidence of Chronic Post Thoracotomy Pain Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Incidence of chronic post thoracotomy pain syndrome
研究概览
简要总结
Pregabalin, administered prior to and following lateral thoracotomy surgery will reduce the likelihood of chronic post-thoracotomy pain syndrome (CPTPS).
详细描述
A total of 200 patients scheduled for lateral thoracotomy will be randomly assigned to receive either placebo or 150 mg pregabalin (Lyrica)1 hour prior to surgery, 12 hr after surgery and then every 12 hr for an additional 10 days. While in the hospital, patients will be assessed for pain intensity, satisfaction and side effects. Patients will be re-assessed at 2, 4 and 6 months following surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective open thoracotomy for primary thoracic surgery, understanding and provision of written informed consent, ASA class I II or III
排除标准
- •Inability ot adhere to study protocol:
- •intolerance or hypersensitivity to any agents to be used in the study, contraindication to thoracic epidural placement
- •inability to respond to the study questionnaire
- •renal insufficiency(serum creatinine > 1.5 upper limit of normal)
- •Body Mass index > 40
- •planned post-operative ventilation.
- •Confounding procedural factors which might affect validity of data:
- •previous ipsilateral thoracotomy
- •surgery for tumor extending into the chest wall
- •rest pain in proposed surgical area pre-operatively
- •chest tube in situ at time of surgery
- •requirement for second thoracotomy or re-occurrence of disease after surgery *isolated pleuroscopy or pleurodesis procedures.
- •Potential interaction with study medications and patient's current medications:
- •current alcohol or other substance abuse
- •chronic steroid use
- •pre-existing chronic pain requiring chronic analgesic use
- •history of seizure disorder requiring treatment with an anticonvulsant
- •current therapy with thiazolidinedione class oral hypoglycemic agents (eg, Actos, Avandia or Avandamet)
- •history of congestive heart failure
- •major psychiatric disorder
- •any contraindication to use of NSAIDs.
- •Insufficient safety data in the patient population:
- •patients requiring preoperative assistance or assistive device for ambulation, pregnant or breastfeeding
- •weight <50 Kg
- •dizziness while inpatient.
研究组 & 干预措施
Placebo capsules
one placebo capsule will be administered 1 hour before lateral thoracotomy, 12 hours following the thoracotomy and then every 12h BID for 10 days following lateral thoracotomy.
干预措施: Pregabalin (Drug)
pregabalin capsules
Pregabalin capsules (150mg) will be administered one hour before lateral thoracotomy, 12 hours following the thoracotomy and then every 12 hours (BID) for 10 days following lateral thoracotomy.
干预措施: Pregabalin (Drug)
结局指标
主要结局
Incidence of chronic post thoracotomy pain syndrome
时间窗: 6 months following surgery
次要结局
- During hospital stay: pain intensity, PEF and FEV1, patient satisfaction, medication side effects. At 2, 4, and 6 months: pain intensity, pain quality (neuropathic versus other), quality of life, pain interference with daily function(During hospital stay and at 2, 4, and 6 months postoperatively)
研究者
Jorge Zamora
Associate Professor, MD, FRCPC
Queen's University