The Effect of Gabapentin on Thoracic Epidural Analgesia Following Thoracotomy - A Randomized, Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Usage of epidural infusion of local and opioid analgesics (ml)
研究概览
简要总结
The purpose of this trial is to investigate the effect of gabapentin on thoracic epidural analgesia following thoracotomy, including assessment of both analgesia, pain intensity, pain quality and whether or not gabapentin prevents the development of chronic pain conditions following thoracotomy.
The main hypothesis is that gabapentin reduces the proportion of patients who develop a persistent pain condition following thoracotomy from 50% to 20%.
Furthermore gabapentin is expected to reduce both pain intensity measured on a 11-point numerical rating scale, usage of epidural infusions of local and/or opioid analgesics, morbidity, hospital length of stay, consumption of opioid analgesics and analgesia-related side-effects.
In addition gabapentin is expected to improve postoperative recovery by means of postoperative lung function, walking ability, health related quality of life and patient satisfaction
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective lung resection via thoracotomy
- •Age > 18 and < 80 years
排除标准
- •Inability to answer the detailed questionnaires on pain and quality of life
- •Psychiatric disease (ICD-10)
- •Severe renal impairment (se-creatinin > 110 mmol/l)
- •Known allergy to gabapentin, morphine, bupivacaine and / or ibuprofen
- •Standard use of opioid analgesics
- •Treatment with anticonvulsants or tricyclic antidepressants
- •Use of antacids 24 hours before the intake of study medication
- •Contraindicated placement of a thoracic epidural catheter
- •Previous ipsilateral thoracotomy
- •Presence of a chronic pain syndrome
- •Acute pancreatitis
- •A history of past or current alcohol and / or illegal substance abuse.
- •A history of gastric or duodenal ulcer
- •Gastrointestinal obstruction
- •Pregnancy
- •Participation in another intervention study
研究组 & 干预措施
Gabapentin
Gabapentin group
干预措施: Gabapentin (Drug)
Placebo
Placebo group
干预措施: Placebo (Drug)
结局指标
主要结局
Usage of epidural infusion of local and opioid analgesics (ml)
时间窗: Within the first 5 postoperative days
Acute postoperative pain
时间窗: Within the first 5 postoperative days
Acute postoperative pain is measured on a 11-point numeric rating scale both at rest and when coughing/sitting up. General pain intensity and specific (shoulder) pain intensity are measured. On postoperative day 4 pain is furthermore assessed by means of the Brief Pain Inventory (BPI-SF) and The McGill Pain Questionnaire (SF-MPQ). A score \>=3 is considered as moderate pain.
Persistent post surgical pain
时间窗: 12 months following surgery
Pain is assessed by means of the Brief Pain Inventory (BPI-SF) and The McGill Pain Questionnaire (SF-MPQ). Persistent postoperative pain is measured both on a 11-point numeric pain rating scale and on a 10 cm visual analog scale (VAS). A score \>=3 is considered as moderate pain.
Early postoperative pain
时间窗: 14 days (+/-3 days) following discharge
Early postoperative pain is measured on day 14 (+/-3 days) following discharge pain using the Brief Pain Inventory (BPI-SF) and The McGill Pain Questionnaire (SF-MPQ). A score \>=3 is considered as moderate pain.
次要结局
- Health related quality of life(12 months following surgery)
- Patient satisfaction(Within the first 5 postoperative days)
- Intensity of preoperative anxiety(2 hours after administration of the first dose of study medication)
- Convalescence of lung function (spirometry)(Within the first five postoperative days)
- Hospital length of stay (days)(At time of discharge)
- Convalescence of gastrointestinal function(Within the first 5 postoperative days)
- Use of a vasopressor agent to correct hypotension(Within the first 5 days of surgery)
- Analgesia related side-effects(Within the first 5 postoperative days)
- Sleep quality(Within the first five postoperative days)
- Walking distance (meters)(Postoperative day 3)
- Fatigue(Within the first 5 postoperative days)
- Consumption of opioid analgesics(Within the first 5 postoperative days)
- Time to first request for additional analgesics(Within the first 5 postoperative days)