跳至主要内容
临床试验/CTRI/2025/04/083840
CTRI/2025/04/083840招募中4 期

To Study the efficacy of ultrasound guided caudal block for post operative analgesia in patients undergoing femur fracture surgery under subarachnoid block

Mahatma Gandhi medical college and hospital1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年1月5日最近更新:

试验速览

阶段
4 期
状态
招募中
入组人数
70
试验地点
1
主要终点
Assessment of pain using VAS ( visual analogue scale ) score at interval of 2hrs for 24hrs between the two groups.

研究概览

简要总结

It is a prospective, randomised, hospital based study to be conducted by Department of Anaesthesia, Mahatma Gandhi Medical College & Hospital, Jaipur.

After ethical committee’s approval, informed written consent will be obtained from all patients.

After doing all the required investigation, PAC will be performed a day before the surgery.

Patients will be randomly divided into two groups of 35 each with the help of computer generated randomization tables method. All patients will be explained about the technique.

研究设计

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

入排标准

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

入选标准

  • Patient scheduled for femur fracture surgeries under subarachnoid block.
  • Patient with ASA grade I,II and III.

排除标准

  • Subject’s refusal to participate in the study Any bleeding disorder or patient on anticoagulants.
  • Neurological deficits History of drug allergy.
  • Local infection at the injection site.
  • Patients on any sedatives or antipsychotics.

结局指标

主要结局

Assessment of pain using VAS ( visual analogue scale ) score at interval of 2hrs for 24hrs between the two groups.

时间窗: 0,2nd hour, 4th hour, 6th hour, 8th hour, 10th hour, 12th hour, 14th hour, 16th hour, 18th hour, 20th hour, 22nd hour, 24th hour.

Group B : The alternative intravenous pain management group (Control group)

时间窗: 0,2nd hour, 4th hour, 6th hour, 8th hour, 10th hour, 12th hour, 14th hour, 16th hour, 18th hour, 20th hour, 22nd hour, 24th hour.

Group A : Ultrasound Guided caudal block group- 0.2% Ropivacaine 0.3-0.5ml/kg

时间窗: 0,2nd hour, 4th hour, 6th hour, 8th hour, 10th hour, 12th hour, 14th hour, 16th hour, 18th hour, 20th hour, 22nd hour, 24th hour.

次要结局

  • To assess the time of first rescue analgesia between the two groups.(To assess & compare the total dose required in first 24 hour post- operatively in both patient groups.)

研究者

申办方类型
Private medical college

研究点 (1)

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