Intrathecal Catheter Placement Versus Resiting Epidural Catheter After Dural Puncture in Obstetric Patients: a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 181
- 主要终点
- PDPH incidence
研究概览
简要总结
Epidural anesthesia represents the most popular method for pain relief during labour. Unintentional dural puncture (UDP) occurs in 0.4-1.5% of labour epidural analgesia, representing therefore the most common complication. Up to 80% of patients with a UDP may develop a post-dural puncture headache (PDPH).
When a UDP occurs, two possible strategies have been proposed in order to ensure analgesia during labour: either resiting the epidural catheter in a different intervertebral space, or inserting an intrathecal catheter. Both strategies proved to equally provide analgesia during labour, but their relative contribution in preventing PDPH is still not known.
The primary aim of this multicenter randomized controlled trial is therefore to compare these two strategies in the occurrence of PDPH at 24 hours from the UDP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of UDP during labour
- •Written informed consent
排除标准
- •Refusal to participate in the study
- •History of PDPH
结局指标
主要结局
PDPH incidence
时间窗: At 24 hours from UDP
Incidence of post-dural puncture headache (PDPH) at 24 hours from UDP occurrence
次要结局
- PDPH intensity at 24 hours(At 24 hours from UDP)
- PDPH intensity at 48 hours(At 48 hours from UDP)
- Chronic pain at 1 month(At 1 month from UDP)
- Chronic pain at 3 months(At 3 months from UDP)
- Readmission to hospital(Up to 3 months from UDP)
- Quality of analgesia(During the entire course of labour, an average of 12 hours)
- Adverse events(During the entire follow-up period, up to 3 months from UDP)
- Patient's satisfaction(Before discharge, an average of 1 week)