Comparative Study Between Subcostal Transversus Abdominis Plane Block Analgesia and Epidural Analgesia in Upper Abdominal Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Total morphine consumption
研究概览
简要总结
The investegators aimed to compare the efficacy of subcostal Transversus abdominis plane analgesia, to epidural analgesia intra and postoperatively in upper abdominal surgeries.
详细描述
Epidural analgesia, once considered the gold standard for major abdominal surgeries, but is often associated with sympathetic blockade that creates hypotension and could therefore adversely affect the conduit. Epidural analgesia is recently replaced by other techniques with an improved risk benefit ratio. Pain management techniques that use peripheral nerve blockade are becoming more prevalent, reducing the need for an epidural. Transversus abdominis plane (TAP) approach is aimed to access the nerves in this neurofacial plane between internal oblique muscle and transversus abdominis through the lumbar triangle of Petit. Subcostal Transversus abdominis plane block, has been reported to provide analgesia for incisions extending above the umbilicus. However, there have been few clinical trials on the analgesic efficacy of continuous subcostal Transversus abdominis plane analgesia after major abdominal surgeries. It has been reported recently that supplemental magnesium has a role in providing perioperative analgesia, because this is a relatively harmless molecule, not expensive and because the biological basis for its potential antinociceptive effect is promising. No clinical studies have examined the effect of magnesium sulphate administered continuously in subcostal Transversus abdominis plane catheters as an adjunct to bupivacaine in postoperative analgesia.
The aim of this study is to compare the efficacy of subcostal Transversus abdominis plane analgesia, to epidural analgesia in major upper abdominal surgeries.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) physical status I, II or III
- •The incision included is right subcostal incision for major upper abdominal surgeries (partial hepatectomy, pancreatic surgery included Whipple's procedure, total pancreatectomy and distal pancreatectomy) and other operations using the same incision.
排除标准
- •Patient refusal.
- •Hematological diseases.
- •Bleeding diseases.
- •Coagulation abnormality.
- •Local skin infection
- •Sepsis at site of the block.
- •Known hypersensitivity to the study drugs.
- •Body Mass Index > 35 Kg/m
- •If the lower end of the incision extended below T10 (umbilicus).
- •If the incision extended laterally beyond the anterior axillary line or extended to pass the midline to the other side.
结局指标
主要结局
Total morphine consumption
时间窗: For 72 hours after surgery
Intravenous morphine in adose of 0.05 mg/kg will be given if Visual Analogue Scale (VAS) is more than 30 mm in both groups and can be repeated every 15 minutes till Visual Analogue Scale become less than 3. Morphine administration will be ceased when the Visual Analogue Scale score \<30 mm on assessment or when over-sedation or respiratory depression occurred (a respiratory rate of \< 10 bpm). Doses given will be calculated daily and recorded.
次要结局
- Pain Scores(up to 72 hours postoperatively)
- First request for rescue analgesia(for 72 hours after surgery)
- Heart rate(for 72 hours postoperative)
- Mean arterial blood pressure(for 72 hours postoperative)
- Peripheral oxygen saturation(for 72 hours postoperative)
- Nausea and vomiting(up to 72 hours postoperatively)
- Degree of sedation(for 72 hours postoperative)
- Serum level of magnesium sulphate(up to 72 hours postoperatively)
- Patient satisfaction with their analgesia(up to 72 hours postoperatively)
- Wound pain(up to 3 months postoperatively)