Perioperative Gabapentin for Chronic Post-thoracotomy Pain: a Randomized, Double Blind, Placebo-controlled Study.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 201
- 试验地点
- 1
- 主要终点
- Persistent chronic post-thoracotomy pain
研究概览
简要总结
To assess the effects of prolonged preoperative gabapentin treatment (10 days) on chronic pain after thoracotomy.
详细描述
Randomized, double blind study enrolling 200 adults undergoing thoracotomy. Patients receive either 75 mg hydroxyzine before surgery and placebo 3 times daily for 10 days or 1200 mg gabapentin before surgery continued for 10 days. All patients receive also a thoracic epidural analgesia.
Assessment of chronic pain at 3 month with an evaluation by a physician (pain intensity, pain quality and analgesia requirement).
Assessment of acute pain in the early postoperative period (pain intensity, pain quality and analgesia requirement).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age > 18 years
- •elective lung resection via thoracotomy
排除标准
- •extended pleurectomy and chest wall resection
- •previous ipsilateral thoracotomy
- •previous ipsilateral radiotherapy
- •thoracotomy for pyothorax
- •chest injury
- •palliative surgery
- •contraindicated placement of a thoracic epidural catheter
- •allergy to medications on protocol
- •pre-existing pain syndrome
- •current treatment with morphine, gabapentin, pregabalin, anticonvulsivants or tricyclic antidepressants
- •a history of past or current drug addiction
- •severe hepatic, renal or cardiovascular disorders
- •inability to understand the study protocol or to answer the questionnaires on pain and quality of life
- •severe psychiatric disorders
- •incompetent adults under some form of guardianship
- •refusal of the protocol
- •persons without social security coverage
- •pregnant or lactating woman
研究组 & 干预措施
gabapentin group
- the day before surgery : gabapentin 400 mg orally
- preoperatively (2 hours before surgery) : 3 capsules each containing 400 mg gabapentin (total gabapentin dose 1200 mg) and intravenous infusion of 50 ml of normal saline solution
- postoperative day 1 to 10 : 400 mg x 3 ( gabapentin 1200 mg daily)
干预措施: Gabapentin (Drug)
placebo group
- The day before surgery: 1 placebo capsule orally
- preoperatively (2 hours before surgery) : 3 placebo capsules and intravenous infusion of 75 mg hydroxyzine
- postoperative day 1 to 10: 1 placebo capsule x 3
干预措施: Placebo (Drug)
结局指标
主要结局
Persistent chronic post-thoracotomy pain
时间窗: 3 months after surgery
Pain intensity is measured on a 11-point numeric pain rating scale ; a score \>=0 is considered as chronic pain.
次要结局
- Heath related quality of life(3 months after surgery)
- Qualitative pain assessment: incidence of neuropathic pain(3 months after surgery)
- Quantitative pain assessment: Acute postoperative pain intensity(Within the first 10 postoperative days)
- Quantitative pain assessment: Rescue analgesics requirement(Within the first 3 months after surgery)
- Quantitative pain assessment: volume of epidural infusion(Within the 5 postoperative days)
- Qualitative pain assessment: Rescue analgesics requirement for neuropathic pain(within the first 3 months after surgery)
- Qualitative pain assessment: Objective assessment of hyperalgesia by the Von Frey filaments test(3 months after surgery)
- Assessment of sedation in the operating room(baseline)