Comparison of epidural dexamethasone-ropivacaine and fentanyl-ropivacaine for ambulatory labour analgesia- A triple blind prospective randomized study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare the total amount of ropivacaine when used with dexamethasone in one group and when used with fentanyl in the other group in laboring parturients with ambulatory epidural labor analgesia
研究概览
简要总结
Continuous research for balanced labour analgesia that provides relief
from pain while prserving motor functions has lead to development of
ambulatory labour analgesia techniques. Ambulatory labour analgesia is a
popular choice for labour analgesia because ambulation reportedly
incrteases increases maternal comfort, increases the intensity of uterine
contractions and eventually shorten labour. Various studies have
concluded that epidural tramadol is a safe and effective method for
labour pain relief better than iv tramadol. Studies that compare different
combinations of epidural drug delivery for ambulatory labour analgesia
from indian clinical scenario are few. thus, we are planning to study
effect of intermittent bolus of ropivacaine 0.1% with comination of
fentanyl 2 microgram/ml and ropivacaine 0.1% with combination of tramadol
2mg/ml in parturients with ambulatory labour analgesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Singleton pregnancy with cephalic presentation in established labor with contractions that occur at regular intervals and become stronger with passage of time (NICE guidelines).
- •Term pregnancy with POG ranging from 37-41 weeks Reassuring cardiotocographic finding Patients requesting for ambulatory labor analgesia.
排除标准
- •Patient refusal for the procedure.
- •Local infection at site of epidural catheter placement.
- •Thrombocytopenia.
- •Coagulopathies.
- •HELLP syndrome.
- •PROM Sepsis.
- •Spinal column deformities and spine surgery.
- •Patient having hypersensitivity to the study drug.
- •In case of Intrathecal catheter placement.
- •In case of accidental dural puncture.
结局指标
主要结局
To compare the total amount of ropivacaine when used with dexamethasone in one group and when used with fentanyl in the other group in laboring parturients with ambulatory epidural labor analgesia
时间窗: To check the vitals, drug consumption, ambulation at 0 minute, 15 minutes,30 minutes and then every hour
次要结局
- blood pressure, heart rate, respiratory rate, oxygen saturation throughout the obstetrical variables including duration of labour, mode of delivery, intrapartum & postpartum complications.(duration of ambulation in both groups.)