CTRI/2025/07/091116尚未招募不适用
Efficacy of combined sacral erector spinae plane block with epidural for labour analgesia during second stage of labour: A randomized controlled trial
All India Institute of medical Sciences, New Delhi1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年8月15日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Incidence of breakthrough pain during second stage of labour.
研究概览
简要总结
| Standard epidural analgesia may not provide adequate pain relief during the second stage of labour, particularly in the sacral and perineal regions. By evaluating the effectiveness of adding a sacral erector spinae plane (ESP) block to epidural analgesia, the study aims to determine whether this combination can offer more complete and targeted pain relief, enhance maternal satisfaction, and reduce the need for additional interventions—areas currently lacking robust evidence from randomized controlled trials. Therefore, the study aims to compare the analgesic efficacy of sacral erector spinae block for the management of second stage of labour pain in parturient patients. |
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 42.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Pregnant women, with gestational age of 36-42 weeks requesting pain relief in labour 2.Gravid, primiparous pregnant women planned for normal delivery 3.Pregnant women aged between 18-42 years 4.Singleton births with vertex presentation.
排除标准
- •Patients not giving consent for the study
- •Allergic to local anesthetics
- •Hypertensive disorder of pregnancy, Cardiac abnormalities, neurological defects, systemic infections
- •History of drug/alcohol abuse
- •Coagulopathy/on anticoagulants/abnormal bleeding profile
- •Infection in the area block
- •Emergency cases
- •Fetal anomalies, cephalopelvic disproportion 10.
结局指标
主要结局
Incidence of breakthrough pain during second stage of labour.
时间窗: Time point at breakthrough pain during 2nd stage of labour
次要结局
- NRS scores for pain(Baseline, every hourly in 1st stage of labour & every 30 min during 2nd stage of labour)
- Assessment of sensory level(Baseline,every hourly in 1st stage of labour & every 30 min during 2nd stage of labour)
- Assessment of motor block(Baseline,every hourly in 1st stage of labour & every 30 min during 2nd stage of labour)
- Need for additional pain relief & number of top-up boluses given(From Baseline & whenever NRS score is more than 4)
- Incidence of assisted vaginal birth/ conversion to LSCS(at end of delivery)
- Patient satisfaction score(2hrs after delivery)
- Pain during episiotomy & suturing(Baseline at episiotomy)
- Duration of second stage of labour(From 10 cm dilation to delivery of baby)
研究者
M Sindhu Raghuveera
All India Institute of Medical Sciences
研究点 (1)
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