跳至主要内容
临床试验/CTRI/2025/03/081977
CTRI/2025/03/081977尚未招募不适用

Epidural labor analgesia evaluation of efficacy of magnesium sulphate as an adjuvant to Ropivacaine and fentanyl mixture

Government medical collegeKadapa1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年3月12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
80
试验地点
1
主要终点
To compare onset of analgesia between both groups

研究概览

简要总结

A STUDY TITLED ’EPIDURAL LABOR  ANALGESIA -EVALUATION OF EFFICACY OF MAGNESIUM SULPHATE AS AN ADJUVANT TO ROPIVACAINE AND FENTANYL MIXTURE ’ WAS CARRIED OUT IN GOVERNMENT GENERAL HOSPITAL,KADAPA DURING THE PERIOD FROM OCTOBER 2022-MARCH 2024

THIS STUDY INCLUDED 80 PRIMI PARTURIENTS DIVIDED RANDOMLY INTO TWO GROUPS EACH 40 PATIENTS .IN GROUP A PARTURIENTS RECEIVED TOTAL VOLUME OF 12 ML OF 0.125% ROPIVACAINE PLUS 25MCG FENTANYL FOR EPIDURAL LABOR ANALGESIA.ADITIONALLY,AN EPIDURAL TOP  UP OF 9ML OF 0.125% ROPIVACAINE WAS ADMINISTERED WHEN THE NUMERICAL RATING SCALE SCORE WAS MORE THAN 3.IN CONTRAST GROUP B RECEIVED THE SAME VOLUME OF 12 ML OF 0.125% ROPIVACAINE  PLUS 25MCG FENTANYL AND 50MG MAGNESIUM SULPHATE FOR EPIDURAL LABOR ANALGESIA.SIMILARLY,AN EPIDURAL TOP UP OF 9ML OF 0.125% ROPIVACAINE WAS ADMINISTERED WHEN THE NRS SCORE WAS MORE THAN 3.

DEMOGRAPHIC DATA WERE COMPARABLE IN BOTH GROUPS .OUR STUDY MONITORED PARAMETERS INCLUDING ONSET AND DURATION OF ANALGESIA ,NRS SCORES ,NUMBER OF TOP UPS ,MATERNAL EXPULSIVE EFFORTS,MODE OF DELIVERY,APGAR SCORES AND HEMODYNAMIC VARIABLES.

FINDINGS REVEALED A SIGNIFICANTLY FASTER ONSET OF ANALGESIA IN GROUP B COMPARED TO GROUP A WITH SIGNIFICANTLY LONGER DURATION OF ANALGESIA IN GROUP B AS WELL.MATERNAL EXPULSIVE EFFORTS AND MODE OF DELIVERY WERE COMPARABLE BETWEEN BOTH GROUPS.ADDITIONALLY THERE WERE NO STASTICAL DIFFERENCE IN APGAR SCORES AT 1 MINUTE AND 5 MINUTES BETWEEN TWO GROUPS

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 33.00 Year(s)(—)
性别
Female

入选标准

  • Primi parturient American society of anaesthesiologists physiological status II Cervical dilatation with 3 cm.

排除标准

  • Parturients with bleeding disorders Parturients with local or systemic sepsis Parturients with known hypersensitivity to study drugs Parturients with spinal deformities those who has undergone spinal surgeries Parturient’s with PIH CPD breech presentation multiparty ,GDM ,multiple or high risk surgeries.

结局指标

主要结局

To compare onset of analgesia between both groups

时间窗: 1,3,5 ,10 mins

次要结局

  • To compare duration of analgesia between two groups(To detect difference in numerical rating scale between two groups)

研究者

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

Veeramalla Pooja

Government Medical college

研究点 (1)

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