The efficacy and safety of Ropivacaine in comparison to Lignocaine for perineal pain relief after Episiotomy - A double blind randomized controlled trial
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- To compare the requirement of extra analgesia in both groups upto 6 hours after episiotomy
研究概览
简要总结
SUMMARY
Normal labour is the most common and expected mode of delivery, which is sometimes
complicated by perineal tears associated with few complications.
Episiotomy is given during 2nd stage of labour to prevent serious tears to the perineum, but
one has to go through much pain when an episiotomy is given and also during its repair.
So, various methods have been applied to reduce the pain caused by episiotomy, including the
injection of local anaesthetics. Traditionally,Lignocaine has been used as a local anaesthetic
for repairing episiotomy. Similarly,Ropivacaine, which belongs to the same class of local
anaesthetics as lignocaine, has diverse uses and a wide safety margin with good antinociceptive
action. It is also a cost-effective drug.
The study aims to compare the analgesic efficacy and maternal satisfaction withlignocaine
**1% versus Ropivacaine 0.75%**infiltration for postpartum perineal pain management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator 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
- •All pregnant females delivered by vaginal route requiring episiotomy ( mediolateral type).
排除标准
- •Antenatal females not willing to participate in the study.
- •Allergy to local anaesthetics agents or Ropivacaine
- •Those who received epidural analgesia in labour.
- •3rd degree perineal tear/ complete perineal tear (CPT).
- •Instrumental delivery.
- •Third stage complications like uterine inversion, PPH.
结局指标
主要结局
To compare the requirement of extra analgesia in both groups upto 6 hours after episiotomy
时间窗: To compare the requirement of extra analgesia in both groups upto 6 hours after episiotomy
次要结局
- 1. To study the visual analogue scale (VAS) score immediately after suturing, 6hrs & 24 hours after episiotomy repair, comparing Lignocaine 1% & Ropivacaine(0.75% as a local anaesthetic)
研究者
Dr Manasa T K
AIIMS Jodhpur