Postoperative Epidural Analgesia in Spine Fusion Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Assessment of pain
研究概览
简要总结
we aim to compare the analgesic effect of 0.125% bupivacaine HCL, 0.125% bupivacaine HCL + Morphine sulphate 3 mg, 0.125% bupivacaine HCL + Fentanyl 100 micro gram both at rest and mobilization maneuvers.
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
- Double (Care Provider, Outcomes Assessor)
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
- •patients undergoing spine fusion surgery.
排除标准
- •Drug addiction. Intraoperative dural tear. Uses of opioids drug for any reason in the previous 48 hours. Mental dysfunction. Spinal fusion for any infectious or malignant causes.
研究组 & 干预措施
Bupivacaine
0.125% Bupivacaine HCL @ 4-5 ml/h
干预措施: 0.125% Bupivacaine HCL @ 4-5 ml/h (Drug)
Bupivacaine, Morphine
0.125% Bupivacaine HCL , Morphine sulphate 3 mg @ 3-5 ml/h
干预措施: 0.125% Bupivacaine HCL , Morphine sulphate @ 3 mg 3-5 ml/h (Drug)
Bupivacaine, Fentanyl
0.125% Bupivacaine, Fentanyl 100 mic @ 3-5 ml/h
干预措施: 0.125% Bupivacaine, Fentanyl 100 mic @ 3-5 ml/h (Drug)
结局指标
主要结局
Assessment of pain
时间窗: first 3 postoperative days
• Pain will be assessed using the VAS ranging from "0" (no pain) to "10" (worst imaginable pain). Pain will be evaluated at rest, while coughing, and during mobilization. Maneuvers of particular clinical importance for postoperative mobilization (alone and with help) will be chosen: Turning in bed, standing in front of the bed and walking, and using the toilet without help. The time needed until the patient can first successfully perform these maneuvers will be documented.
次要结局
- assessment of patients' satisfaction(First 3 postoperative days)
研究者
Omnia Askar
assistant lecturer of anesthesia and ICU, Assiut University
Assiut University