跳至主要内容
临床试验/CTRI/2025/07/091587
CTRI/2025/07/091587尚未招募不适用

A comparative study of epidural nalbuphine versus fentanyl for analgesic efficacy in patients undergoing infraumbilical surgeries under spinal anesthesia.

Dr Varshini G1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年10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
60
试验地点
1
主要终点
Analgesic efficacy of epidural nalbuphine versus fentanyl in terms of duration of Analgesia in patients undergoing infraumbilical surgeries under spinal anesthesia in 24 hours

研究概览

简要总结

This study is a randomized control,  double blinded study, comparing the analgesic efficacy of epidural nalbuphine 5mg versus fentanyl 50 mcg in patients undergoing infraumbilical surgeries under spinal anesthesia that will be conducted in bangalore medical college and research institute and the allied hospitals. The primary outcome is to compare the analgesic efficacy and secondary outcome is to assess the onset of sensory and motor blockade,  duration of motor blockade,  2 segment regression,  VAS scores, ramsay sedation scores and time for first rescue analgesic.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator 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 giving consent, ASA grade 1 and 2, BMI 18 to 29 kg/m^2.

排除标准

  • Allergy to local anesthetic, spine deformity, coagulopathy,chronic pain syndromes, cardiac diseases, liver and kidney dysfunction, neurological disorders, pregnancy and breastfeeding mothers, technical failure, patients on tricyclic antidepressants, alpha 2 agonist and opioids.

结局指标

主要结局

Analgesic efficacy of epidural nalbuphine versus fentanyl in terms of duration of Analgesia in patients undergoing infraumbilical surgeries under spinal anesthesia in 24 hours

时间窗: Analgesic efficacy of epidural nalbuphine versus fentanyl in terms of duration of Analgesia in patients undergoing infraumbilical surgeries under spinal anesthesia in 24 hours

次要结局

  • Compare onset of sensory & motor blockade, duration of motor blockade, 2 segment regression, VAS, ramsay sedation scale, time of first rescue analgesia.(In 24 hrs)
  • Assess hemodynamic parameters perioperatively(24 hours)
  • Assess incidence of any side effects of study drugs(In 24 hours)

研究者

发起方
Dr Varshini G
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Varshini G

Bangalore medical college and research institute

研究点 (1)

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