Pain Treatment in Posterior Thoracolumbar Operation a Randomized Study to Assess the Effect of Local Analgesia After Operation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- pain
研究概览
简要总结
Posterior thoracolumbar operation always chooses general anesthesia. Due to surgical trauma and rich periosteum and joint capsule innervation, patients after general anesthesia immediately feel acute pain.The use of appropriate postoperative analgesia in patients with thoracolumbar surgery is beneficial to postoperative recovery. Infusions of local anaesthetic via multilumen catheters that deliver directly to wound sites have been used for postoperative analgesia in procedures. Reducing the morbidity from both pain and nausea will make the mode of analgesia a better tolerated and more palatable option for patients. The aim of this study is to examine the effects of using local anaesthetic infusion catheters following posterior thoracolumbar surgery, and compares the outcomes of patients managed using intravenous analgesia pump infusion of systemic opioids.
详细描述
All 71 adult patients were prospectively included and randomized to either the local (L) group (n=35) or the intravenous (V) group (n=36) by using a random number table: the test group were treated with local analgesia infusion pump of 0.33% ropivacaine through the wound for postoperative analgesia, while the control group were treated with intravenous analgesia pump infusion of flurbiprofen axetil,palonosetron, pentazocine. At 2, 4, 6, 12, 24, 36, 48 hours after operation, postoperative pain visual analogue scale(VAS) scores and sedation Ramsay scores were used to evaluate the level of pain and sedation, and investigators documented the comprehensive evaluation of patients with pain control system, and the incidence of adverse reactions. At 24, 48 hours investigators observed the wound whether inflammation and exudation or not, and the removal of penetration catheter sent to clinical laboratory for bacterial culture. Investigators also recorded the length of time to discharge and called to ask pain conditions at the first 3 months.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA Ⅰ ~ Ⅱ patient undergoing elective posterior thoracolumbar operation
- •between 18 and 70 years of age
排除标准
- •A history of cardiopulmonary disease, liver and kidney dysfunction, abnormal coagulation
- •Preoperative use of analgesic drugs
- •A allergy history of ropivacaine and polyurethane material
研究组 & 干预措施
Local
This group uses local analgesia infusion pump of 0.33% ropivacaine 250ml through the wound for postoperative analgesia.
干预措施: local (Other)
Local
This group uses local analgesia infusion pump of 0.33% ropivacaine 250ml through the wound for postoperative analgesia.
干预措施: 0.33% ropivacaine 250ml (Drug)
intravenous
This group is treated with intravenous analgesia pump infusion of flurbiprofen axetil 150mg,palonosetron 0.5mg,pentazocine 240mg.
干预措施: intravenous (Other)
intravenous
This group is treated with intravenous analgesia pump infusion of flurbiprofen axetil 150mg,palonosetron 0.5mg,pentazocine 240mg.
干预措施: flurbiprofen axetil 150mg,palonosetron 0.5mg,pentazocine 240mg. (Drug)
结局指标
主要结局
pain
时间窗: 48 hours postoperation
Up to 48 hours after operation,postoperative pain visual analogue scale(VAS) scores are used to evaluate the level of pain.
次要结局
- sedation(48 hours postoperation)
- comprehensive evaluation(48 hours postoperation)
研究者
bo xu
associate chief physician
Guangzhou General Hospital of Guangzhou Military Command