Evaluation of the Postoperative Analgesic Efficacy of Catheter Placed Interpectoral Region Via Open Technique in Patients Undergoing Modified Radical Mastectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 主要终点
- VAS scores
研究概览
简要总结
patients undergoing modified radical mastectomy were divided into two groups. patients in catheter group were placed a catheter with open technique by the surgeon in the pectoral area. thirty minutes before extubation %1 lidocain 10 ml, %0.5 bupivacain 10 ml and 10 ml %0.9 sodium chloride were given through the catheter for postoperative analgesia. patients in iv analgesia group were given 100 mg tramadol iv 30 minutes before extubation. visual analog pain scale (VAS) scores, rescue analgesic requirement, complications were recorded and compared between two groups 1, 6, 12, 24 hours and 90 days after surgery.
详细描述
patients undergoing modified radical mastectomy were divided into two groups by computer. patients in catheter group were placed a catheter under clavipectoral fascia in the neighbourhood of nervus thoracicus longus, nervus thoracodorsalis, nervus pectoralis lateralis, nervus pectoralis medialis at the 1/3 lateral part of clavicula. solution included 10 ml of %0.5 bupivacain, %1 lidocain, 10 ml %0.9 sodium chloride totally 30 ml were given via the catheter for postoperative analgesia at the end of surgery. patients in iv analgesia group were given 100 mg tramadol iv 30 minutes before extubation. Patients in both groups were given dexketoprofen 50 mg iv if the VAS score was over 4. VAS scores, rescue analgesic requirement and timing, complications were recorded and compared between groups 1, 6, 12, 24 hours and 90 days after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •American Society of Americans Class I-II
排除标准
- •allergy to local anesthetics or
- •anticoagulant drug use
- •central or peripheric nerve disease
- •pregnancy
研究组 & 干预措施
iv analgesia
patients were given intravenously 100 mg of tramadol (contramal) 30 minutes before extubation after modified radical mastectomy.
干预措施: catheter (Device)
iv analgesia
patients were given intravenously 100 mg of tramadol (contramal) 30 minutes before extubation after modified radical mastectomy.
干预措施: iv analgesia (Drug)
catheter group
patients were placed a catheter under clavipectoral fascia and 30 ml of local anesthetic solution were given via catheter for postoperative analgesia
干预措施: catheter (Device)
catheter group
patients were placed a catheter under clavipectoral fascia and 30 ml of local anesthetic solution were given via catheter for postoperative analgesia
干预措施: iv analgesia (Drug)
结局指标
主要结局
VAS scores
时间窗: 24 hours after operation
patients were asked to give a point between 0 to 10 for their pain level. 0 is no pain, 10 is the strongest pain.
次要结局
- VAS scores(3 months after operation)
研究者
Guniz M.Koksal
professor
Istanbul University