跳至主要内容
临床试验/CTRI/2018/12/016807
CTRI/2018/12/016807已完成不适用

Comparison of analgesic efficacy of bupivacaine, bupivacaine and dexmedetomidine, and bupivacaine and Fentanyl in would infiltration technique in perianal surgeries: A prospective, randomized controlled study.

GOPALAKRISHNAN K1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2019年1月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
75
试验地点
1
主要终点
Dexmedetomidine prolongs the postoperative analgesia of wound infiltration with bupivacaine and is superior to addition of fentanyl to local local would infiltration with

研究概览

简要总结

This study is a randomized, double blind, parallel group, controlled, multiarm trial comparing the efficacy of dexmedetomidine  1.5micg/kg and fentanyl 2micg/ml when added to the local aneasthetic solution used for would infiltration done at the end of surgery in patients undergoing uncomplicated perianal surgeries to be conducted at Aarupadai Veedu medical college and Hospital, Pondicherry. The primary outcome measures will be prolonging the postoperative analgesia duration when compared to control group. The secondary outcome measures will be reduction in total number of analgesics received over first 24 hrs and better defaecation score on the next day. Dexmedetomidine provides superior analgesia  than Fentanyl.

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 50.00 Year(s)(—)
性别
All

入选标准

  • Patients undergoing uncomplicated perianal surgeries like haemorrhoidectomy, fissure in ano and fistula in ano, ASA I & II, Normal BMI.

排除标准

  • ASA III and above, Obese, underweight subjects(BMI) , pregnant women, patients with bleeding and clotting disorders, allergic to local anesthetic agents,inadequate spinal blockade supplemented by other drugs and complicated surgeries will be excluded from the study.

结局指标

主要结局

Dexmedetomidine prolongs the postoperative analgesia of wound infiltration with bupivacaine and is superior to addition of fentanyl to local local would infiltration with

时间窗: 12hours

次要结局

  • Total analgesics requirement in 24 hrs is reduced when dexmedetomidine is added to local anaesthetic solution. Addition of Fentanyl to local anaesthetic solution also reduces total analgesic requirement(24hrs)
  • pain perception at daefacation on next day is less intense.(24 hours)

研究者

发起方
GOPALAKRISHNAN K
申办方类型
Private medical college

研究点 (1)

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