跳至主要内容
临床试验/CTRI/2017/05/008467
CTRI/2017/05/008467招募中不适用

randomised trial comparing the incidence of unintended sciatic nerve block following ultrasound guided pudendal nerve block with two different volumes of ropivacaine for hemorrhoidectomy

Shri Sathya Sai Medical College and Research Institute1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年2月13日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
Compare the Incidence of unintended sciatic nerve block with two different volumes of ropivacaine

研究概览

简要总结

30 patients undergoing elective hemorrhoidectomy would be dived randomly divided into to two groups.Written informed consent would be obtained from the patient.All the patients would be fasted pre operatively for 6 hours.On the day of surgery ,the motor power  and sensation of the sciatic nerve would be noted.An intravenous cannula would be started and the patient would be loaded with 10ml/kg RL.The patients vitals would be monitored and the patient would be place in the prone position.For patient belonging to group I ,the pelvis would be scanned with a 3-6 mega hertz ultrasound probe starting from the Posterior superior illiac spine and advanced down to identify the Greater sciatic foraman and the Piriformis.Once when the piriformis is identified then the probe is still moved caudally until the piriformis disappears and the sacrospinous and the sacrotuberous ligament is noted.The probe is adjusted such that the sciatic nerve is visualised lateral to the ischial spine and the pudendal nerve and artery is visualised medial to the ischial spine in the interligamentous plane.the neerdle is advanced under real time ultrasound guidance till the tip reaches the inter ligamentous plane medial to the pudendal artery.Once when the position is confirmed 10 ml of 0.25% of ropivacaine is injected incrementally after repeated aspiration for blood and the spread of injectate to the sciatic nerve would be noted.The same procedure would be repeated in the opposite side.For patients belonging to group II the same procedure would be repeated but the volume of 0.25% ropivacaine injected would be 5ml on each side.Following the block the patient would be turned to supine position and general anaesthesia induced and appropriate sized LMA would be inserted and the surgical procedure would be completed.After the procedure the patient would be reversed from general anaesthesia and the outcomes would be assessed.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients aged between 18 to 60 years posted for elective hemorrhoidectomy .
  • Patients belonging to ASA physical status I and II.
  • Willingness to participate in the study.

排除标准

  • ASA III and above.
  • Psychiatric illness.
  • Patients on anticoagulants .
  • Any neuropathic illness.

结局指标

主要结局

Compare the Incidence of unintended sciatic nerve block with two different volumes of ropivacaine

时间窗: 1)Spread of drug to the sciatic nerve confirmed with ultrasound 2)Signs of motor or sensory involvement in the ditribution of sciatic nerve in the first 24 hrs after surgery

次要结局

  • 1)Time of block would be taken as time zero,time of first analgesic requirement would be calculated in minutes from this point(2)Total demand of analgesics in 24 hours would be noted)

研究者

发起方
Shri Sathya Sai Medical College and Research Institute
申办方类型
Private medical college

研究点 (1)

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