跳至主要内容
临床试验/CTRI/2025/03/082474
CTRI/2025/03/082474尚未招募Phase 3 4

Effectiveness of bupivacaine and levobupivacaine for epidural labour analgesia

Gandhi Medical College Bhopal Madhya Pradesh1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2025年3月27日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
75
试验地点
1
主要终点
To determine the overall effectiveness of levobupivacaine or ropivacaine in terms of onset,quality of analgesia and degree of motor blockade

研究概览

简要总结

The patients will receive nil per oral instructions before the

labour. After shifting the patients to the labour analgesia room,

standard non-invasive anaesthetic monitoring like blood pressure,

five leads electrocardiography and pulse oximetry will be

connected to the patient. Baseline vitals such as heart rate,

blood pressure, mean arterial pressure, and oxygen saturation of

the patient will be recorded after 5 mins settling in the labour

analgesia room. An intravenous line will be established. The

epidural space will be found using an 18-gauge Tuohy needle at

either L2–L3 or L3–L4 in the sitting position. Loss of resistance will

be used to identify the epidural space. Epidural catheter will be

inserted up to the desired length and secured at L2-L3 or L3-L4.

For the study, the test dose will be omitted. Levobupivacaine or

bupivacaine will be diluted with 0.9% w/v saline to achieve the

desired concentration at room temperature. For initiation of labour

analgesia, first bolus administration (12ml of 0.2%) of

levobupivacaine or bupivacaine will be given over 5 minutes when

cervical dilatation will become >3 cm and then analgesia will be

maintained with infusion of 0.1% levobupivacaine or 0.1%

bupivacaine till the delivery of the baby.

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 35.00 Year(s)(—)
性别
Female

入选标准

  • Full Term Female Pregnant Women Singleton Pregnancy and Vertx Presentation Active stage of labour ASA Grade I.

排除标准

  • Cardiovascular disease, Neuromuscular diseases Major sicknesses like bronchial asthma and tuberculosis Severe eclampsia Received opioid or sedative drugs Drug allergies Physical disability.

结局指标

主要结局

To determine the overall effectiveness of levobupivacaine or ropivacaine in terms of onset,quality of analgesia and degree of motor blockade

时间窗: To determine the overall effectiveness of levobupivacaine or ropivacaine in terms of onset,quality of analgesia and degree of motor blockade

次要结局

  • To Assess the maternal fetal outcome & maternal satisfaction score(at the time of delivery of the baby & thereafter every hour till 6 hrs after delivery)

研究者

发起方
Gandhi Medical College Bhopal Madhya Pradesh
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Deeksha Singh Thakur

Gandhi medical college,bhopal

研究点 (1)

Loading locations...

相似试验