Estimation of Pain During Epidural Analgesia During Labor - a Monocentric Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pupil diameter variability
研究概览
简要总结
Epidural regional anesthesia is a technique to eliminate or lessen pain during obstetric labor and childbirth. It consists in establishing a catheter into the epidural space and to block the transmission of pain sensations by injecting a local anesthetic and an opioid. In 10-25% of cases the epidural does not give perfect results, causing it to test its effectiveness, which is mainly done by questioning the patient on mitigation or disappearance of pain. This collaboration of patients is sometimes limited in our care structure by the inability to assess or express the pain, mainly due to cultural differences or language barriers, which can represent up to 15% of women in our institution. This led to develop objective measures of pain techniques used at the bedside.
Pupil diameter (PD) varies under the double influence of sympathetic system (Σ), dilator of the pupil, and parasympathetic system (pΣ).
The PD increases in response to painful stimulation, in proportion to the intensity of the nociceptive stimulus. This variation of PD has been proposed as a means of evaluation of pain in patients under general anesthesia, but has been little studied in conscious subjects.
There are other permanent changes in the PD, due to constant interaction between Σ and pΣ systems. Few data have been published to date on this PD variability (PDV).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Obstetrical Labor
- •Able to rate their pain using VAS
- •dilatation of the cervix under 6 centimeters
- •Written consent
排除标准
- •- Not having a anesthesia consultation during the 48 hours before delivery
- •With a contra-indication for an epidural
- •To which an incident occurred during a previous epidural using a medication used in the study
- •Operated a unilateral or bilateral ocular surgery modifying the possibilities of variation of pupil diameter
- •general anesthesia in the seven days preceding delivery
- •Carry a pacemaker or heart grafted
- •Having Parkinson's disease history, insulin or non-insulin diabetes or chronic alcoholism
- •Having cardiac arrhythmia (atrial fibrillation or frequent extrasystoles)
- •Treated for hypertension by receptor antagonists of angiotensin type 2
- •anti-arrhythmic treatment or blocker,
- •Refusing to participate in the study
- •With a contra-indication for the use of ropivacaine and sufentanil.
研究组 & 干预措施
Patients
Pain assess by :
- Visual Analogic Scale (VAS).
- Portable video pupillometer
干预措施: Portable video pupillometer (Device)
结局指标
主要结局
Pupil diameter variability
时间窗: From baseline to fifteen minutes after start of Epidural regional anesthesia
Compare Pupil Diameter Variability (PDV) measured before Epidural regional anesthesia and after Epidural regional anesthesia. PDV is aera under the curve of Pupil Diameter from start of the contraction (baseline) to time to peak of the contraction.
次要结局
- pupil diameter(From baseline to fifteen minutes after start of Epidural regional anesthesia)
- Visual Analogic Scale (VAS)(From baseline to fifteen minutes after start of Epidural regional anesthesia)