Effectiveness of bupivacaine and levobupivacaine for epidural labour analgesia
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
Dr Deeksha Singh Thakur
Gandhi medical college,bhopal
