COMPARISON OF EPIDURAL, COMBINED SPINAL EPIDURAL AND DURAL PUNCTURE EPIDURAL TECHNIQUES FOR LABOR ANALGESIA
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Primary Aims:-
研究概览
简要总结
Various method of labour analgesia are now available which are safe and effective; beneficial to both the mother and the fetus. Lumbar epidural has been the mainstay since many years. Combined Spinal Epidural analgesia has emerged as newer and safe alternative technique. A recent technique of Dural Puncture Epidural is now a days becoming popular. The aim of the present study is to compare Epidural, Combined Spinal Epidural and Dural Puncture Epidural techniques for labour analgesia using levobupivacaine along with fentanyl as adjuvant. Aim will be accomplished by carrying out a study in 60 parturients of ASA grade 1 and 2 in age group of 20-35 years. The parturients will be randomly divided into 3 groups of 20 each. Group E (Epidural Group) will receive 15ml of 0.125% isobaric Levobupivacaine with 30µg fentanyl in the epidural space. Group CSE (Combined Spinal Epidural group) will receive1.2ml (3mg) of intrathecal 0.25% isobaric Levobupivacaine with 25µg fentanyland epidural top up of 15ml of 0.125% Levobupivacaine with 30µg fentanyl. Group DPE (Dural Puncture Epidural group) will receive 15ml of 0.125% isobaric Levobupivacaine with 30µg fentanyl in epidural space while intrathecal medication will be withheld. Epidural top up dose will be given according to assessment of pain while Visual Analogue Scale (VAS). All the vitals will be monitored till the end of delivery. Analgesic efficacy extent of sensory and motor block, maternal and fetal outcome, duration of analgesia and maternal satisfaction score will be compared and analyzed statistically.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •Pregnant women with Singleton pregnancy, at term, cephalic presentation and in active stage of labour, with full term live fetus.
- •Primigravida (without any obstetric complications) requesting labour analgesia
- •ASA Physical Status 1 and 2
- •Having regular contractions at least once every 5 minutes
- •Parturient belonging to age group 20-35years
- •Height> 145cm
- •BMI 18-25(weight/height2).
排除标准
- •Patient refusal
- •Patient with gestational hypertension, preeclampsia, gestational diabetes mellitus
- •Any contraindication for neuraxial procedures
- •Cephalopelvic disproportion
- •Coagulation disorders and bleeding disorder
- •Hypersensitivity to the drug under study
- •Any spine deformity
- •Any obstetric complications
- •History of any drug abuse
- •History of any cardiac arrhythmias or labile hypertension.
结局指标
主要结局
Primary Aims:-
时间窗: All these parameters are recorded at 2 minutes interval for first 10 minutes, at 5 minute interval from 10 to 30 minutes and at 15 minutes interval from 30 minutes to 300 minutes or until the end of delivery, whichever is earlier.
• Onset of sensory & motor block
时间窗: All these parameters are recorded at 2 minutes interval for first 10 minutes, at 5 minute interval from 10 to 30 minutes and at 15 minutes interval from 30 minutes to 300 minutes or until the end of delivery, whichever is earlier.
• Duration of sensory and motor block
时间窗: All these parameters are recorded at 2 minutes interval for first 10 minutes, at 5 minute interval from 10 to 30 minutes and at 15 minutes interval from 30 minutes to 300 minutes or until the end of delivery, whichever is earlier.
Quality of analgesia
时间窗: All these parameters are recorded at 2 minutes interval for first 10 minutes, at 5 minute interval from 10 to 30 minutes and at 15 minutes interval from 30 minutes to 300 minutes or until the end of delivery, whichever is earlier.
次要结局
- Secondary Aims:-(• Maternal Hemodynamic)