Analgesia Nociception Index (ANI) After Unilateral Radical Mastectomy as an Evaluation of Paravertebral Block Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Assessment of the ANI index
研究概览
简要总结
Paravertebral Block (PVB) combined with general anesthesia (GA) is a conventional pain treatment for breast surgery but sometimes failures can occurs. The efficacy of this block has to be evaluated. Also, for the intra-operative analgesic evaluation of this block, it is necessary to measure intra-operative analgesia index. A monitor of nociception for patients under GA, the PhysiodolorisTM device, offers an index for measuring nociceptive inputs during surgery in anesthetized patients : the ANI index (based on the single R-R interval analysis). The purpose of this observational and prospective study is to assess the variations of this ANI index during breast surgery with or without axillary node dissection with a PVB. This will allow us to quantify the analgesic effect of a PVB during GA for unilateral radical breast surgery with or without axillary node dissection.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •American Society of Anesthesiologists score (ASA) I or II
- •Patients aged over 18 years
- •BMI between 17 and 30 kg/m2
- •Radical mastectomy with or without axillary node dissection.
排除标准
- •Preoperative consumption of opioid
- •Local Anesthesia allergy
- •Local skin inflammation at the puncture area
- •Inability to respond to pain assessment using a Numerical Rating Score (NRS)
- •Any contra-indication or patient's refusal for regional anesthesia B blocker medication
- •Pace maker
- •Inability to perform the PVB (at the appreciation of the anesthesiologist)
- •Change of surgical procedure other modified radical mastectomy with or without axillary node dissection.
- •Patient with a severe side effect or who cannot be controlled by additional therapy will be removed from the trial
结局指标
主要结局
Assessment of the ANI index
时间窗: first minute of the surgical incision
Assessment of the area under the curve of the variation of the ANI index for the first minute of the surgical incision according to the PVB failure: incomplete or ineffective vs effective. The PVB failure will be evaluate with a cold test on the thoracic levels T2 and T6.
次要结局
- Post Anesthesia Care Unit total dose of morphine will be compare according to the PVB failure or not groups.(Just after surgery (day 0))
- Evaluation of pain(Just after surgery (day 0) and the day after surgery (day 1))