A Prospective, Randomized, Double Blinded, Placebo Controlled Pilot Study Assessing the Effect of Perioperative Pregabalin on the Incidence of Chronic Post Thoracotomy Pain Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- The Primary Outcome Measure for the Final Study Will be the Incidence of CPTPS at 2 Months.
研究概览
简要总结
With Institutional Ethics Board approval and signed informed consent, a pilot investigation was conducted in which 15 adult patients scheduled to undergo a thoractomy were randomly assigned to receive 1) 150 mg pregabalin 1 hour preoperatively and then 7 days postoperatively (BID) or 2) 300 mg pregabalin 1 hour preoperatively and 7 days postoperatively (BID) or 3) placebo for same regimen to assess the feasibility, safety and compliance of this drug regimen on this patient population. This assessment was necessary in order to plan a future fully powered randomized controlled trial looking at the efficacy of perioperative pregabalin ifor reducing the incidence/severity of chronic post-thoracotomy pain.
详细描述
Chronic post thoracotomy pain syndrome (CPTPS) is a significant problem that has important effects on patients' daily activities. The severity of postoperative pain and the central sensitization associated with it are thought to play a role in the chronification of acute pain. Gabapentin has been shown to be effective in reducing acute post-surgical pain and treating CPTPS. There is conflicting data regarding its effects on the development of chronic post-surgical pain. Although pregabalin is similar to gabapentin there are only a few studies examining its use in the modification of post-surgical pain but evidence suggests that it might be effective. There are no studies examining the effect of pregabalin on the development of chronic post-surgical pain. Our hypothesis is that perioperative use of pregabalin will decrease the incidence of CPTPS. Our ultimate goal is to conduct a multi-center study assessing the effect of perioperative oral pregabalin on the development of CPTPS. Prior to this, we will carry out a prospective, randomized, placebo controlled, double-blinded pilot study to assess the feasibility, safety, and compliance associated with perioperative use of oral pregabalin in patients undergoing video assisted thoracotomy surgery (VATS) or open thoracotomy procedures.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective thoracotomy (ET) or video assisted thoracotomy (VAT);
- •Understanding and provision of written informed consent;
- •Age > 18 and < 75;
- •ASA class I, II or III.
排除标准
- •Inability to adhere to study protocol;
- •Intolerance or known hypersensitivity to any agents to be used in the study;
- •Contraindication to thoracic epidural placement in open thoracotomy patients;
- •Inability to respond to the study questionnaire;
- •Renal insufficiency (serum creatinine > 1.5 x upper limit of normal);
- •BMI > 40;
- •Confounding procedural factors which might affect validity of data;
- •Surgery for tumour extending into the chest wall;
- •Requirement for second thoracotomy or re-occurrence of disease after surgery;
- •Potential interaction with study medications and patient's current medications;
- •Current ETOH or substance abuse;
- •Pre-existing chronic pain requiring chronic analgesic use;
- •History of seizure disorder requiring treatment with an anti-convulsant;
- •Current therapy with thiazolidinedione class oral hypoglycemic agents (e.g. Actos, Avandia, or Avandamet);
- •History of congestive heart failure;
- •Major psychiatric disorder;
- •Insufficient safety data in a specific patient population;
- •Pregnant or breastfeeding.
研究组 & 干预措施
Perioperative pregabalin
Pregabalin 150mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-operatively (n=3) or Pregabalin 300mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-operatively (n=4).
干预措施: Pregabalin (Drug)
Placebo control
An identical placebo administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op. (N=8)
干预措施: Placebo (Drug)
结局指标
主要结局
The Primary Outcome Measure for the Final Study Will be the Incidence of CPTPS at 2 Months.
时间窗: 2, 4, and 6 months
Incidence of Chronic Post-thoracotomy Pain at 2 Months Postoperatively
时间窗: 2 months postoperatively
Incidence of post-thoracotomy pain syndrome (persistent continuous or intermittent chest pain with resting pain score \> 4 on a 10 point NRS scale)
次要结局
未报告次要终点