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临床试验/CTRI/2023/12/060886
CTRI/2023/12/060886尚未招募不适用

A comparision of epidural butorphanol and fentanyl as an adjuvant with 0.5%levobupivacaine for postoperative analgesia in patients undergoing vaginal hysterectomy

JLN medical college1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年4月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
Duration of analgesia

研究概览

简要总结

This will be a double blinded randomized study conducted to evaluate inj. Butorphenal 2mg and inj. fentanyl 50 mcg as an adjuvant with inj.levobupivacaine 0.5% 15ml epidurally in  patients who are between 30 to 70yr old, ASA grade 1 or 2 with excemption of all exclusion criteria mentioned above and  undergoing vaginal hysterectomy under epidural analgesia with primary objective of comparing the  duration of analgesia. seconadry objectives being onset and duration of sensory block, onset and duration of motor block, cardiovascular effects, side effects . participants will be allocated in to 2 groups  each with 40 sample size . Group LB receiving inj.butorphenal group LF receiving inj.fentanyl as an adjuvant with local anaesthetic epidurally in above mentioned dosagey. pre anaesthetic evaluation will be done previous day , necessary premedication will be given , informed written consent will be taken prior  to surgery. all emergency drugs and equipments will be kept ready in prior. under all aseptic precautions respective drugs will be given epidurally to respective group of patient. patient will be monitored intraoperative and postoperatively. all the parameters will be recorded at pre described interval  and documented. data will be analyses statistically using standard qualitative and quantitative tests. continuous variables will be analyzed using student paired test and chategorical variables will be analyzed using chi-square test. P value of less than  0.05  will be considered significant.

研究设计

研究类型
Interventional
分配方式
Random Number Table
盲法
Participant and Investigator Blinded

入排标准

年龄范围
30.00 Year(s) 至 70.00 Year(s)(—)
性别
Female

入选标准

  • ASA 1 and 2 female undergoing vaginal hysterectomy.

排除标准

  • ASA >2 comorbidities pregnant patients breastfeeding local infection.

结局指标

主要结局

Duration of analgesia

时间窗: assessment of visual analogue score for pain in postoperative period at immediately after shifting post operative unit,after 1hr,2hr,3hr,4hr, 6hr,8hr,10hr

次要结局

  • onset & duration of sensory block(onset duration of motor block)

研究者

发起方
JLN medical college
申办方类型
Government medical college

研究点 (1)

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