The Effect of Epidural Anesthesia on the Intra-operative and Post-operative Amount of Bleeding Following Lower Limb Salvage Surgery
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Measure the blood loss intra- and post-operative in both the contro and study groups
研究概览
简要总结
Epidural anesthesia is a very useful tool in lower limb salvage surgery, which helps pain control intra and more importantly post-operative pain. It is a well-known effect of epidural injections to cause a sympathetic stimulation and consequently vasodilatation in the lower limb vessels.
Since epidural catheters can cause vasodilatation in lower limb vessels, they can subsequently lead to increased intra and post-operative bleeding from the surgical wound.
The study will involve all patients having a bone tumor in the lower limb and subjected to tumor resection and reconstruction by prosthesis.
The patient will be randomized according to the administration of epidural anesthesia into two arms, an arm in which epidural anesthesia was employed and another arm in which the patient was subjected only to general anesthesia and the amount of intra and postoperative bleeding will be compared in both arms.
详细描述
Assessment of intra-operative bleeding will be based upon weighing and counting of the blood soaked dressing and the amount of blood transfusion used.
Assessment of post-operative bleeding will be based upon the amount of blood collected from the suction drain and amount of blood transfusion.
All patient subjected to anticoagulant post-operative or another type of surgery other than implantation of prosthesis will be excluded from the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •lower limb bone tumor
- •reconstruction by prosthesis
排除标准
- •upper limb and pelvic salvage surgery.
- •other methods of reconstruction than prosthesis
- •use of tourniquet intra-operative.
- •post-operative anticoagulation.
研究组 & 干预措施
Control group
Control group in whom no epidural anesthesia will be applied
Epidural Anesthesia
the group in whom all patients will be subjected to epidural anesthesia intra- and post-operative
干预措施: epidural anesthesia (Other)
结局指标
主要结局
Measure the blood loss intra- and post-operative in both the contro and study groups
时间窗: start of surgery until removal of sucction drain
The amount of blood loss will be assessed using: * Intra-operative: measurement of dressing before and after being soaked. * Post-operative: amount of blood drainage and duration of use of the suction drain.
次要结局
- prolongation of hospital stay(the number of days calculated from date of surgery until dischare from hospital expected average from 5 to 7 days)