A COMPARATIVE STUDY OF INTRATHECAL ISOBARIC ROPIVACAINE 0.75% WITH FENTANYL VERSUS ISOBARIC 2 -CHLOROPROCAINE 1% WITH FENTANYL IN PATIENTS UNDERGOING LOWER SEGMENT CAESAREAN SECTION
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- •Onset of sensory blockade
研究概览
简要总结
In this study, we will compare the efficacy ofintrathecal isobaric ropivacaine 0.75% (22.5mg) with fentanyl (25mcg) versusisobaric 2-chloroprocaine 1 %(30mg) with fentanyl (25mcg) in patientsundergoing lower segment caesarean section.
PRIMARY OBJECTIVE:
· Onset of sensory blockade
· Duration ofanalgesia.
SECONDARY OBJECTIVES:
· Highest level ofsensory blockade
· Duration of sensoryblockade.
· Onset of motorblockade.
· Duration of motorblockade.
· Quality of motorblock
· Two segment regression.
· Effect on hemodynamicparameters.
· Neonatal outcome.
· Complications likenausea, vomiting, pruritus, respiratory distress, sedation, bradycardia (<50bpm),hypotension (decrease in SBP>30% baseline or <100mm Hg
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Parturients posted for LSCS
- •Age between 18 – 40 years.
排除标准
- •Age < 18 and > 40 years.
- •Patients refusal.
- •Patient sensitive / allergic to local anaesthetic agents.
- •Patients with peripheral sensorineural deficit.
- •Patients on anticoagulants.
- •Infection at the site of lumbar puncture.
结局指标
主要结局
•Onset of sensory blockade
时间窗: Time duration of the study is around 1 year
•Duration of analgesia.
时间窗: Time duration of the study is around 1 year
次要结局
- •Highest level of sensory blockade(•Duration of sensory blockade.)