CTRI/2025/09/095099尚未招募4 期
A Comparative study of 0 point 1 percent Ropivacaine with or without Fentanyl for Epidural Labour analgesia A Randomized Controlled study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To compare the VAS score in both groups
研究概览
简要总结
The goal of our present study is a comparative study of 0.1% Ropivacaine alone or with Fentanyl (2 mcg/ml) for Epidural Labour Analgesia in randomized controlled double blind study with regard to VAS score ( pain intensity score), duration of different stages of labour, time of onset of analgesia,hemodynamic parameters,Neonatal assessment (APGAR Score), patient satisfaction score ,Complications related to drug/epidural catheter.
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 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •Age between 18 and 35 years
- •ASA grade I and II in active stage of labour (greater than or equal to 3 cm dilatation)
- •Primigravida
- •Singleton pregnancy
- •Vertex presentation
- •Uncomplicated pregnancy
- •Parturients requesting labour analgesia.
排除标准
- •Patient refusal
- •ASA grade III and IV
- •Age greater than 35 years and less than 18 years
- •Multipara patients(greater than 2 children)
- •Comorbid conditions like Severe cardiac disease, Severe Pregnancy induced Hypertension, Eclampsia, Severe anemia, Psycological/Neurological disease
- •Complicated preganancies like Cephalo Pelvic disproportion, Breech presentation, Cord around neck and Previous Caesarean section.
- •Local sepsis
- •Altered coagulation profile
- •Bleeding disorders, thrombocytopenia
- •Spinal deformities
- •History of allergy to study drug.
结局指标
主要结局
To compare the VAS score in both groups
时间窗: 0,5,15,30,45,60,90 minutes,every hourly maximum up to 8hrs
次要结局
- Time of onset of analgesia,Total dose of analgesia required,Total duration of labour,Neonatal outcome,Patient satisfaction score(0,5,15,30,45,60,90 min,every hourly maximum up to 8hrs, APGAR Score at 1 & 5 min.)
研究者
Dr Devendra Verma
RNT Medical College & MB Hospital,Udaipur.
研究点 (1)
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