跳至主要内容
临床试验/CTRI/2024/05/067351
CTRI/2024/05/067351已完成不适用

A COMPARATIVE STUDY OF INTRATHECAL HYPERBARIC BUPIVACAINE WITH FENTANYL AND INTRATHECAL HYPERBARIC ROPIVACAINE WITH FENTANYL IN ELECTIVE LOWER SEGMENT CAESAREAN SECTION.

Sree Balaji Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年6月3日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
To compare the onset of analgesia between the two different study groups concerning the nature of sensory block, motor block, and duration of analgesia.

研究概览

简要总结

Spinal anaesthesia is the standard Anesthetic choice for lower segment cesarean section (LSCS), except in a few cases where it is contraindicated. This study is to compare the effects of the combination of either Ropivacaine, or Bupivacaine with fentanyl (one of the most used adjuvants in intrathecal administration). they have additive effects when applied together in the subarachnoid space, with greater analgesic quality and duration, safety, and also longer-lasting post-surgical analgesia, which is clinically significant. The rationale behind this study is to observe and assess the effect of 0.5%hyperbaric bupivacaine with fentanyl and 0.75% hyperbaric ropivacaine with fentanyl when administered through intrathecal route for elective caesarean deliveries

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 45.00 Year(s)(—)
性别
Female

入选标准

  • Those who consented to be part of the study and gave written consent women who are undergoing elective cesarean section for baby delivery ASA II patients.

排除标准

  • ASA Grade III or Above Patients in whom spinal anesthesia was contraindicated Pre-operative hemodynamic instability, maternal heart disease, and severe anaemia History of allergy to local anaesthetic or opioids.

结局指标

主要结局

To compare the onset of analgesia between the two different study groups concerning the nature of sensory block, motor block, and duration of analgesia.

时间窗: After the Administration of intrathecal local anaesthetics and opioids postoperatively, the patient is observed every 15mins 30 minutes 1 hr then every 1hr up to 24hrs

次要结局

  • To find out the effectiveness and hemodynamics of the drugs.(To find out the Pain score at 30 min,4hr, 8hr, 12hr post-op.)

研究者

发起方
Sree Balaji Medical College and Hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Rajarajeswari M

Sree Balaji Medical College and Hospital

研究点 (1)

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