Dexmedetomidine Combined With Bupivacaine for Erector Spinae Plane Block Versus Bupivacaine Alone for Postoperative Pain Control of Posterior Lumbosacral Spine Fixation Surgeries
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Postoperative visual analogue scale (VAS)
研究概览
简要总结
As the posterior lumbosacral spine fixation surgeries are common spine procedures done nowadays due to different causes and as this spine procedure is mostly accompanied with moderate to severe postoperative pain, so it is necessary to find an effective and efficient postoperative analgesia for patients with this surgery.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •elective posterior lumbosacral spine fixation and fusion surgery due to different causes that diagnosed clinically and radiologically including MRI and Plain X ray
排除标准
- •hypersensitivity to the drugs used in the study [local anesthetics, non-steroidal anti-inflammatory drugs, opioids and the drug under investigation (dexmedetomidine)]
- •patients with any contraindication to regional anesthesia as skin infections at the site of the block
- •history of bleeding disorders or receiving anticoagulant medications
研究组 & 干预措施
control group (S group)
patients received 20 ml of normal saline 0.9%.
干预措施: normal saline (Drug)
Dexmedetomidine combined with bupivacaine group (DB group)
patients received 1ug/kg dexmedetomidine plus 20 mL of bupivacaine 0.25%,
干预措施: Dexmedetomidine injection (Drug)
Dexmedetomidine combined with bupivacaine group (DB group)
patients received 1ug/kg dexmedetomidine plus 20 mL of bupivacaine 0.25%,
干预措施: Bupivacaine 0.25% Injectable Solution (Drug)
bupivacaine 0.25%,
patients received 20 ml of bupivacaine 0.25%
干预措施: Bupivacaine 0.25% Injectable Solution (Drug)
结局指标
主要结局
Postoperative visual analogue scale (VAS)
时间窗: the first 24 hours postoperative
The visual analog scale (VAS) is a simple and often used method for evaluating variations in pain intensity.
Amount of post operative opioid consumption for the first 24 hours
时间窗: the first 24 hours postoperative
Amount of total opioid consumption for 24 hours postoperative
次要结局
- Postoperative visual analogue scale (VAS)(the second 24 hour postoperative)
- Amount of post operative opioid consumption for the second 24 hours(the second 24 hour postoperative)
研究者
engy wahsh
lecturer of clinical pharmacy
October 6 University