跳至主要内容
临床试验/CTRI/2018/04/013066
CTRI/2018/04/013066招募中不适用

Comparison of epidural anaesthsia and combined sciatic-femoral nerve block for unilateral lower limb surgeries.

Bhagat Phool Singh Government Medical College For Women1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2018年4月2日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
76
试验地点
1
主要终点
To compare the success rate of anaesthesia in both the techniques.

研究概览

简要总结

Patients comfort andadequate intraoperative anaesthesia is an anaesthesiologist’s first priority.Anaesthesiologist have always tried to develop procedures which give patientmore comfort during surgical procedures, have wide safety margin and minimalrisks associated with it. Lower limb surgery is a common surgical procedure andmany  anaesthetic techniques  like spinal anaesthesia, epidural anaesthesia,peripheral nerve blocks (both single and multiple nerves) are available tofacilitate the surgery.

The primary objectiveof my study is to compare two well established techniques: Epidural andCombined Sciatic-Femoral nerve block and evaluate which is better in view ofsuccessful intraoperative anaesthesia. Secondarily, haemodynamic stability andpatient comfort will be assessed during the two techniques.

The study will becarried out on 76 patients scheduled for lower limb surgeries and will berandomly divided into two groups of 38 each.. In Group A (CSFB), drug solutionfor sciatic- femoral block will be prepared with injection Bupivacaine 3mg/kgmade up to a volume of 45 ml with normal saline and patients will receive 30 mlof the solution for sciatic nerve block and 15 ml for femoral nerve block. InGroup B (EA), patients will receive 15 ml of 0.5% bupivacaine. Adequacy ofintraoperative anaesthesia in terms of success rate, onset and duration ofsensory and motor blocks, haemodynamic parameters and side effects will noted.Since this is a randomised prospective study, the anticipated outcome cannot becommented upon.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • •1.Patients of all gender between 18-65 years of age.
  • •2.American Society of Anaesthesiologists (ASA) grade I to III.
  • •3.Lower limb surgery around and below the knee.
  • •4.No history of uncontrolled chronic illness.
  • •5.Patient who are willing to provide their voluntary written informed consent for participation in the study.

排除标准

  • •1.Patient unwillingness/ lack of consent.
  • •2.Patient with spine deformity, localized sepsis and raised intracranial pressure.
  • •3.Patients with impaired mentation significant neurological, psychiatric, neuromuscular, cardiovascular, pulmonary, renal or hepatic diseases.
  • •4.History of allergy to drugs under study.
  • •5.Pregnant patients.
  • •6.Morbid obesity (BMI>40 kg/m2).
  • •7.Coagulation disorders.

结局指标

主要结局

To compare the success rate of anaesthesia in both the techniques.

时间窗: Intraoperative upto a maximum of 3 hours

次要结局

  • The secondary outcome will be the onset of sensory and motor blockade.(Time of onset of sensory and motor blockade.)

研究者

发起方
Bhagat Phool Singh Government Medical College For Women
申办方类型
Government medical college

研究点 (1)

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