A Multicenter, Randomised, Double-blinded, Placebo-controlled Trial Comparing the Efficacy and Safety of Intravenous Parecoxib Sodium on Morphine Patient-controlled Epidural Analgesia After Gynecologic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 294
- 试验地点
- 1
- 主要终点
- morphine-sparing effect of parecoxib
研究概览
简要总结
The purpose of this study is to determine the effects of parecoxib in combination with epidural morphine in providing analgesia for patients undergoing gynecological surgery.
详细描述
Researches have showed that the use of epidural and spinal block resulted in significant reduction in morbidity and mortality after surgery. Moreover, appropriate pain management results in better outcomes. Opioids therapy is recommended as the first choice medication for the management of postoperative pain but is associated with a number of undesirable adverse effects. A multimodal therapy for providing postoperative analgesia has advantages over the use of opioids alone. The use of NSAIDs and opioids together often improves analgesia and reduces the need for opioids in the postoperative period. Often, the combination of COX-2 inhibitors with epidural analgesia is preferred. With epidural analgesia, addition of COX-2 inhibitors may improve the analgesia and decrease the undesirable side effects.
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women scheduled for elective gynecological surgery under combined spinal-epidural anesthesia
排除标准
- •contraindications for CSE placement
- •known allergy, sensitivity, or contraindication to opioid and nonopioid analgesic drugs
- •history of bleeding disorders, peptic ulceration, or anticoagulant use within the past month
- •current pregnancy or breastfeeding
- •history of known or suspected drug abuse
- •unable to understand the use of pain assessment scales and the PCA device
- •Patient with asthma or bronchospasm, requiring treatment with glucocorticoids
- •poorly controlled hypertension or diabetes, a chronic or acute renal or hepatic disorder, or inflammatory bowel disease
- •patients had taken antidepressants, narcotic analgesics, antihistamines, anxiolytics, hypnotics, sedatives, NSAIDs, or corticosteroids up to 24 h before receipt of the study medication
研究组 & 干预措施
Normal Saline
Before incision, patients in controlled Group received NS
干预措施: Normal saline (Drug)
parecoxib sodium
Before incision, parecoxib patients received 40mg of parecoxib IV
干预措施: Parecoxib Sodium (Drug)
结局指标
主要结局
morphine-sparing effect of parecoxib
时间窗: within 48 h after skin closure
The primary end-point of this study was to quantify the morphine-sparing effect of a multimodal approach containing parecoxib compared with the standard PCEA approach in patients undergoing abdominal hysterectomy.
次要结局
- pain intensity and side effects accompanied with PCEA and parecoxib(within 48 h after skin closure)
研究者
Liu Weifeng
attending doctor
First Affiliated Hospital, Sun Yat-Sen University