Correlation Between NoL Index Response to Standardized Stimulus Under General Anesthesia and: Post-operative Opioid Consumption and Pain, Pre-operative Phenotype and Pain Biomarkers
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Correlation between NoL index and Hydromorphone consumption H24
研究概览
简要总结
This study evaluates the correlation between NoL index response to standardized stimulus under general anesthesia and the post-operative pain, assessed by opioid consumption and numerical pain scores after video-assisted thoracoscopy (VATS).
详细描述
The NoL index, a nociception monitor using a multiparametric approach, has shown an excellent sensitivity and specificity in detecting noxious stimuli under general anesthesia. This monitor is better than any other parameter in grading nociception under general anesthesia. More recently, it has recently been shown a strong correlation between NoL index response to nociceptive stimulus and the level of opioid analgesia during surgery. No study has evaluated that NoL could predict post-operative pain so far. It has not yet been proven that NoL was correlated with post-operative opioid consumption or with post-operative pain scores.
Some phenotypic factors were previously shown to correlate with post-operative pain and opioid consumption, such as psychological factors and tests, or also assessment of some pre-operative nociceptive thresholds (NT). Pain catastrophizing was proven in several studies to correlate with acute post-operative pain.
So far, no study compared each of these preoperative psychological factors or nociceptif thresholds to the NoL index response to intraoperative standardized pain stimulus in terms of correlation with post-operative opioid requirements and pain scores.
Moreover, there is no study evaluating the pro-inflammatory protein profiles that might likely be correlated to inter-individual differences in NoL response after this standardized nociceptive stimulus under general anesthesia.
This study will assess the level of correlation between NoL index response to standardized stimulus under general anesthesia and the post-operative pain, assessed by opioid consumption and numerical pain scores after video-assisted thoracoscopy (VATS). It also evaluates the correlation between NoL index response to standardized stimulus under general anesthesia and pre-operative phenotype and post-operative pain biomarkers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient (Age 18 or older)
- •ASA status I, II or III
- •elective video assisted thoracoscopy under general anesthesia
排除标准
- •history of coronary artery disease
- •serious cardiac arrhythmia (including atrial fibrillation),
- •history of substance abuse,
- •chronic use of psychotropic and/or opioid drugs,
- •use of drugs that act on the autonomic nervous system (including β-blockers),
- •history of psychiatric diseases,
- •allergy to any drug used in the study protocol,
- •refusal of the patient
- •unexpected difficult airway requesting excessive, possibly painful airway manipulations
- •unexpected intraoperative complications requiring strong hemodynamic support (transfusions, vasopressors, inotropes)
- •conversion to thoracotomy
研究组 & 干预措施
Included patients
There is only one arm in this study. Intervention will be electrical forearm stimulus under general anesthesia and the response of NOL index following this stimulus and its correlation with postoperative parameters such as pain and opioid consumption in post anesthesia care unit.
干预措施: Standardized tetanic stimulation (Device)
Included patients
There is only one arm in this study. Intervention will be electrical forearm stimulus under general anesthesia and the response of NOL index following this stimulus and its correlation with postoperative parameters such as pain and opioid consumption in post anesthesia care unit.
干预措施: Catastrophizing score (Diagnostic Test)
Included patients
There is only one arm in this study. Intervention will be electrical forearm stimulus under general anesthesia and the response of NOL index following this stimulus and its correlation with postoperative parameters such as pain and opioid consumption in post anesthesia care unit.
干预措施: Nociceptive threshold (Diagnostic Test)
Included patients
There is only one arm in this study. Intervention will be electrical forearm stimulus under general anesthesia and the response of NOL index following this stimulus and its correlation with postoperative parameters such as pain and opioid consumption in post anesthesia care unit.
干预措施: Biomarkers (Biological)
结局指标
主要结局
Correlation between NoL index and Hydromorphone consumption H24
时间窗: Day 1 at 24 hours
Correlation between NoL index absolute values after electrical stimulus under general anesthesia and Total hydromorphone consumption (PACU and PCA) 24h after surgery
次要结局
- Correlation between NoL index and Pain scores (NRS from 0 to 10) in PACU(Day 0 at hour 2)
- Correlation between NoL index and Pain scores (NRS) from 0 to 10 at H48 at rest(Day 2 at 48 hours)
- total hydromorphone consumption (mg) in PACU(Day 0 at 2 hours)
- Correlation between Pain catastrophizing scale from 0 to 50 and Total (hydromorphone consumption at day 1 24 hours)(Day 1 at 24 hours)
- State-Trait anxiety Inventory from 0 to 80 (fully validated and published questionnaire)(Day 0)
- Pain scores (NRS) at H48 at rest from 0 to 10(Day 2 at 48 hours)
- Correlation between NoL index and total hydromorphone consumption (mg) in PACU(Day 0 at 2 hours)
- Total hydromorphone consumption (mg) at H48(Day 2 at 48 hours)
- Pain catastrophizing scale from 0 to 50 (fully validated and published questionnaire)(Pre-operative, 2 hours prior to surgery)
- mechanic pain threshold(Pre-operative, 2 hours prior to surgery)
- Biomarkers level H24(Day 1 24 hours)
- Brief Pain inventory (3M) Questionnaire (validated and published questionnaire)(3 months)
- Pain scores (NRS) at H48 while coughing from 0 to 10(Day 2 at 48 hours)
- Correlation between NoL index and Pain scores (NRS) from 0 to 10 at H48 while coughing(Day 2 at 48 hours)
- Biomarkers level Pre-op(Pre-operative, H0 right after induction of general anesthesia)
- Biomarkers level H48(Day 2 48 hours)
- Pain scores (NRS) in PACU from 0 to 10(Day 0 at hour 2)
- Correlation between NoL index and Pain scores (NRS) from 0 to 10 at H24 at rest(Day 1 at 24 hours)
- Correlation between Pain catastrophizing scale from 0 to 50 and NoL index(Day 0)
- Correlation between State-Trait anxiety Inventory from 0 to 80 and Total hydromorphone consumption at H24(Day 1 24 hours)
- Pain scores (NRS from 0 to 10) at H24 at rest(Day 1 at 24 hours)
- Pain scores (NRS) at H24 while coughing from 0 to 10(Day 1 at 24 hours)
- Correlation between NoL index and Pain scores (NRS) from 0 to 10 at H24 while coughing(Day 1 at 24 hours)
- Correlation between NoL index and total hydromorphone consumption (mg) at H48(Day 2 at 48 hours)
- Correlation between State-Trait anxiety Inventory questionnaire from 0 to 80 and NoL index(Day 0)
- thermal pain threshold(Pre-operative, 2 hours prior to surgery)
- electrical pain threshold(Pre-operative, 2 hours prior to surgery)
研究者
Philippe Richebe
Director of Research in the Department of Anesthesiology
Ciusss de L'Est de l'Île de Montréal