Effect of Epidural Analgesia on the Parameter ANI During Childbirth
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Hopital Foch
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Comparison of the ANI parameter with the VAS during labour
研究概览
简要总结
There are many methods used for the assessment of pain in the area of anesthesia including heart rate variability which reflects the influence of the autonomic nervous system on the heart. An original index, the ANI (Analgesia Nociception Index), quantifies pain during anesthesia. Obstetric epidural analgesia is particularly suited to evaluate ANI in conscious patients with a comparison of ANI with the measurement of pain by a visual analog scale (VAS).
Evaluation of ANI is performed just before epidural catheter insertion and during the 10 first minutes after saline, sufentanil or lidocaine epidural administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Over 18 years,
- •ASA I or II,
- •No history of cardiovascular or respiratory disease
- •No cardiovascular medication
- •No treatment with a tocolytic agent(salbutamol, nicardipine)
- •Desiring epidural analgesia at the early phase of labor pain
排除标准
- •Too fast labour
- •A pain score at or above 70 on the pain scale
- •A disturbed EKG signal or extrasystoles
- •Pace-Maker
- •Diabetes mellitus
研究组 & 干预措施
Group Saline
Epidural administration of saline
干预措施: NaCl 0.9% (Drug)
Group Sufentanil
Epidural administration of sufentanil
干预措施: Sufentanil (Drug)
Group Lidocaine
Epidural administration of lidocaine
干预措施: lidocaine (Drug)
结局指标
主要结局
Comparison of the ANI parameter with the VAS during labour
时间窗: 2 hours
The main objective of the research is to evaluate ANI as a measurment of pain caused by uterine contractions.
次要结局
- Effects of epidural sufentanil and of epidural local anesthetic on ANI(2 hours)
- Effects of anxiety score on ANI(2 hours)