Can Preemptive Analgesia With Parecoxib Reduce Post-operative Ipsilateral Shoulder Pain? A Double-blinded, Randomized, Placebo-controlled Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Numeric rating scale (NRS) of shoulder pain and incisional pain at rest and movement
研究概览
简要总结
The purpose of this study is to compare the efficacy of parecoxib with placebo on the incidence and severity of postthoracotomy shoulder pain, the amount of analgesic requirement for relieving severity of postthoracotomy shoulder pain and adverse events associated with treatment.
详细描述
The incidence of Post-operative Ipsilateral Shoulder Pain (PISP) varies from 21-97% after thoracic surgery, despite receiving effective thoracic epidural analgesia. This pain has been described as constant, aching in quality, unrelated to position change or respiration. Possible causes of shoulder pain includes injury of the phrenic nerve, the lateral decubitus position, transection of major bronchus or preexisting arthritis condition. The possibilities of prevention and management of PISP are taken into consideration. Thoracic epidural block will be performed in all patients before general anesthesia.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiology (ASA) physical status I-III
- •Undergoing pulmonary resection by open thoracotomy
排除标准
- •Unable to understand numeric rating scale despite preoperative coaching
- •Preexisting shoulder pain at the same operative side
- •Having contraindication for thoracic epidural analgesia
- •History of previous myocardial ischemia or cerebrovascular accident
- •Allergic to NSAIDS, sulfonamides or parecoxib
- •Hepatic or renal impairment
- •History of current gastrointestinal symptoms
- •Fluid retention or congestive heart failure
- •Pregnancy
研究组 & 干预措施
Parecoxib
Parecoxib 2 ml intravenous
干预措施: Parecoxib (Drug)
Control
0.9% sodium chloride 2 ml intravenous
干预措施: Control (Other)
结局指标
主要结局
Numeric rating scale (NRS) of shoulder pain and incisional pain at rest and movement
时间窗: at 2 ,6 ,12 ,24 ,48,72 and 96 hours after the operation
次要结局
- compare an amount of morphine consumption(at 2,6 ,12,24,48,72 and 96 hours after the operation)
- adverse effect related to parecoxib(during 96 hours)
研究者
Tanyong Pipanmekaporn
Department of Anesthesiology,Faculty of Medicine
Chiang Mai University