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临床试验/CTRI/2026/01/101801
CTRI/2026/01/101801尚未招募不适用

Comparative Study of the Characteristics of Sensory and Motor Block Duration of Analgesia Between Intrathecal Hyperbaric Ropivacaine (0.75%) and hyperbaric levobupivacaine (0.5%) Along with 2mg Nalbuphine as an Adjuvant in Patients Undergoing Elective Caesarean Section: A Randomized Controlled Study

GMERS HOSPITAL1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年2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

研究概览

简要总结

This study is a prospective, randomized, double-blind controlled clinical trial designed to compare the characteristics of sensory and motor block produced by intrathecal hyperbaric ropivacaine (0.75%) and hyperbaric levobupivacaine (0.5%), both combined with 2 mg nalbuphine as an adjuvant, in patients undergoing elective caesarean section.

A total of 30 ASA II–III parturients aged 18–40 years scheduled for elective caesarean section under spinal anaesthesia will be enrolled and randomly allocated into two equal groups. Group R will receive 1.8 ml hyperbaric ropivacaine (0.75%) with 2 mg nalbuphine, while Group L will receive 1.8 ml hyperbaric levobupivacaine (0.5%) with 2 mg nalbuphine.

The primary outcome is to compare the onset of sensory and motor block between the two groups. Secondary outcomes include duration of postoperative analgesia, two-segment sensory regression time, intraoperative hemodynamic changes, and incidence of adverse effects such as hypotension, bradycardia, nausea, vomiting, pruritus, shivering, and respiratory depression.

The study aims to identify an intrathecal drug combination that provides effective anaesthesia, stable maternal hemodynamics, adequate postoperative analgesia, and early recovery in patients undergoing elective caesarean section

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • ASA Physical status 2 and 3 Weight.
  • 40 kg to 85 kg.

排除标准

  • Short stature (Ht -150 cm) Patient refusal Patient with allergy to local anesthetics drugs Pre-existing or pregnancy-induced HTN Preeclampsia cardiovascular cerebral diseases Placenta previa placenta abruption Foetal distress or foetal abnormalities Multiple gestations.

研究者

发起方
GMERS HOSPITAL
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Priyanka patel

GMERS MEDICAL COLLEGE GOTRI VADODARA

研究点 (1)

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