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临床试验/CTRI/2025/07/090057
CTRI/2025/07/090057尚未招募4 期

A randomized controlled study for analgesic efficacy of fentanyl as an adjuvant to ropivacaine in caudal epidural block in paediatric patients undergoing infraumbilical surgeries in general anaesthesia

Dr Bhawna meena1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年7月20日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
1. To assess and compare time to first rescue analgesic requirement [duration of

研究概览

简要总结

• STUDY PERMISSION: Due permission from the institution ethics committee and research review board will be obtained. • STUDY AREA: The study will be conducted in the Department of paediatric Anaesthesia, JK Lone Hospital attached to S.M.S. Hospital, Jaipur. • STUDY DESIGN: Prospective , Randomized, Double blind, Interventional study. • STUDY PERIOD: After approval of the plan from the research review board till the completion of desired sample size. • SAMPLE SIZE: sample size is calculated at 80% study power and error of 0.05 assuming standard deviation of 312.84 minutes of duration of analgesia in ropivacaine + fentanyl group as found in seed article(1)for minimum detectable mean difference of 240 minutes in duration of analgesia between the groups , 27 patients in each group are required as sample size which is further enhanced to 30 patients in each group as final sample size for present study expecting 10% attrition. • RANDOMIZATION – opaque sealed envelope method. • DOUBLE BLINDING- The anaesthesiologist who would give caudal block would be different from the anaesthesiologist who would record study variables. • STUDY UNIVERSE: Pediatric Patients undergoing infraumbilical surgeries under general anaesthesia.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Participant and Investigator Blinded

入排标准

年龄范围
3.00 Year(s) 至 6.00 Year(s)(—)
性别
All

入选标准

  • Paediatric Patients undergoing Infraumbilical surgeries in general anaesthesia.
  • Patients with written & informed parental consent/ assent (where able applicable).
  • Weight between 16kg to 25 kg
  • ASA grade I and II.

排除标准

  • Noncooperative patient.
  • Patient should not be part of other study.
  • History of hypersensitivity to study drugs.
  • Patients having bleeding/clotting diseases, local infection, sepsis deformity, pre existing neurological diseases.

结局指标

主要结局

1. To assess and compare time to first rescue analgesic requirement [duration of

时间窗: WITHIN 24 HOURS

postoperative analgesia ] in both the groups .

时间窗: WITHIN 24 HOURS

2. To assess and compare the severity of pain using CHOPS score and RAMSAY

时间窗: WITHIN 24 HOURS

score in both the group.

时间窗: WITHIN 24 HOURS

次要结局

  • 1.To assess and compare the changes in hemodynamic(variables(SBP,DBP,MAP,HR,SpO2) in the intraoperative period in both groups within)

研究者

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

Dr Bhawna meena

S.M.S medical college and hospital jaipur

研究点 (1)

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