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
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
Dr Bhawna meena
S.M.S medical college and hospital jaipur
