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临床试验/CTRI/2023/01/048753
CTRI/2023/01/048753尚未招募3 期

COMPARISON OF EFFICACY BETWEEN 0.25% BUPIVACAINE AND 0.25% LEVOBUPIVACAINE FOR CAUDAL ANESTHESIA IN PEDIATRIC INFRAUMBILICAL SURGERIES

Jaisima Balaji S1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年10月1日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
Duration of analgesia

研究概览

简要总结

In Anaesthesia, provision of pain relief is an essential part. One of the most popular regional blocks in children with higher success rate is caudal block for surgeries below the level of umbilicus. It is a useful adjunct technique during general  anesthesia and for providing post of analgesia for infra umbilical operations. This technique is  easier to perform and reduces the requirement of inhaled and intravenous anesthetic agent. It also attenuates the stress response to surgery, facilitates rapid and smooth recovery and provides reliable analgesia in the immediate post operative period. The quality and level of caudal block is dependent on the dose, volume and concentration of the drug injected. Bupivacaine is long-acting amide local anesthetic that has provided reliable anesthesia and analgesia with differential motor sensory blockade for more than 40years. Cardio toxicity and incidents of prolonged motor blockade urged the need for the development of a drug with wider margin of safety and similar clinical efficacy. So, S-enantiomers of bupivacaine were isolated and synthesized. One of the pure S-enantiomer of bupivacaine is levobupivacaine. It is claimed to have a wider margin of safety like less cardio toxicity and less post operative motor blockade.

研究设计

研究类型
Interventional
分配方式
Stratified block randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
2.00 Year(s) 至 8.00 Year(s)(—)
性别
All

入选标准

  • Patients posted for elective infraumbilical surgeries.
  • Age between 2 years to 8 years of either sex.
  • Weight between 9 to 35kg.
  • Anticipated duration of surgery <60 minutes.
  • ASA grade І or â…¡.

排除标准

  • Emergency surgeries.
  • Known hypersensitivity to amide local anaesthetics.
  • History of active neurological, cardiac, respiratory and renal diseases.
  • Blood dyscrasia, clotting disorders and platelet count <100000 mm
  • Patients with cutaneous infections or anatomical malformation of the spine.
  • Patients not willing to participate in the study.

结局指标

主要结局

Duration of analgesia

时间窗: pain score by FLACC score for every 15minutes in the first hour and every 30minutes for next hour

次要结局

  • To compare the duration of motor blockade between 0.25%bupivacaine and 0.25%levobupivacaine(duration of motor blockade by MODIFIED BROMAGE SCALE for every 15minutes in the first hour and every 30minutes for next hour)
  • To compare the incidence of adverse effects between 0.25%bupivacaine and 0.25% levobupivacaine(Number of adverse effects in the perioperative period)
  • To compare the hemodynamic parameters between 0.25%bupivacaine and 0.25% levobupivacaine(Pulse rate,Blood pressure and oxygen saturation from baseline to every 3minutes for 15minutes and every 5minutes for 30minutes and every 30 minutes fot 120 minutes)

研究者

发起方
Jaisima Balaji S
申办方类型
Other [self]

研究点 (1)

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