Comparison of Postoperative Nociception Outcomes Between NOL - Guided and Standard Intraoperative Analgesia Based on Fentanyl in Patients Undergoing Elective Surgery With General Anesthesia
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
- Consumption of IV fentanyl intra-operative in the NOL-guided group compared to the standard group.
研究概览
简要总结
Pain is defined as an unpleasant sensory and emotional conscious experience, associated with actual or potential tissue damage. Nociception is the sympathetic response to noxious stimuli during unconsciousness. The appearance of different forms of chronic pain results from sensitization of both peripheral and central neural circuits of pain, which involves inflammatory mechanisms both at a systemic level and specifically in the peripheric and central nervous system, as observed through elevation of specific neuroinflammatory mediators, such as MCP-1, IL-1, IL-1b, and IL-10. Clinically, this sensitization expresses as hyperalgesia and allodynia, which increase postoperative pain and morbidity, but also induce permanent modifications in the nociceptive system. These effects may be ameliorated by adequately adjusting intraoperative analgesia through use of nociception/analgesia balance monitors, of which Nociception Level Index (NOL) shows convenient characteristics and promising results from previous studies.
Objectives: The goal of our study is to assess the utility of NOL index monitoring against standard care for Fentanyl-based analgesia by measuring postoperative pain, sensorial thresholds and inflammatory markers related to nociception.
Hypothesis: The use of NOL index to guide the intraoperative analgesia will produce less postoperative pain, hyperalgesia, allodynia, and neuroinflammation.
详细描述
Methodology: In this RCT double-blinded study will invite to 100 patients aged between 18 and 50 years admitted for elective surgery that is planned to require general anesthesia, with fentanyl as the opioid of choice for intraoperative analgesia.
Each patient will be randomly allocated to one of two groups: the intervention group will be provided intraoperative analgesia guided by NOL values (n=50), and the control group will be provided standard intraoperative analgesia (n=50). To account for inter-personal variability, the NOL threshold value associated with nociceptive stimulation will be assessed on each patient at baseline condition with the Quantitative Sensory Testing (QST) and neuroinflammatory mediators MCP-1, IL-1, IL-1b, and IL-10 will be measured pre- and post-surgery in both groups. Opioid consumption and AVS will be assessed during the stay at the post-surgical care unit as a measurement of post-operative pain and will follow them until three months after surgery.
Statistical Analysis
Results will be expressed as means (±SD) or numbers (%). When indicated, 95% confidence interval (CI) will be calculated. A p-value < 0.05 will be considered statistically significant.
Differences between groups on post-surgical opioid consumption, Δz-score of QST measurements, and serum biomarkers level will be analyzed with Student's T-test for unpaired samples. For analysis purposes, VAS scores will be grouped into three distinct categories: Mild (0-3), Moderate (4-6) and Severe (7-10) pain. Differences between groups will be analyzed with Chi-square test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Randomization into group fentanyl NOL-guided vs fentanyl standard will be done prior to the entrance in the OR, the day of the surgery.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective abdominal surgery without a neuraxial block.
- •Over 2 horas.
- •Body Mass Index 18 - 30 kg/m2
排除标准
- •Cardiac surgery
- •Cardiopathy
- •Arrhythmia or use of pacemakers.
- •Chronic Kidney disease (Plasma Crea >1 mg/dL).
- •Allergic to drugs of this study.
- •Opioids or Non-inflammatory drugs over 5 days for two weeks before surgery.
- •Neuropathies and dysautonomias.
- •Beta-blockers and other drugs that act at the level of the sympathetic system the month prior to surgery.
- •Chemotherapy.
研究组 & 干预措施
fentanyl NOL guided
A bolus of 2 mcg/kg IV Fentanyl will be given at the induction of the anesthesia. A bolus of 0,5 - 1 mcg/kg IV Fentanyl will be given at the time of incision and during surgery following a predeterminate NOL index + heart rate + mean arterial blood pressure variations.
干预措施: fentanyl NOL guided (Drug)
结局指标
主要结局
Consumption of IV fentanyl intra-operative in the NOL-guided group compared to the standard group.
时间窗: Intra-operative
Total consumption of fentanyl in mcg.
Consumption of opioid in the early postoperative in the NOL-guided group compared to the standard group.
时间窗: Postoperative Unit (2 hours)
Total consumption of morphine in mg.
次要结局
- Pain Management Satisfaction in the NOL-guided group compared to the standard group.(Postoperative (12 hours))
- Inflammatory markers in the NOL-guided group compared to the standard group.(Postoperative (12 hours))
- Pain measured by Visual Analog Scale (VAS) in the NOL-guided group compared to the standard group.(Postoperative Unit (Every 30 minutes per 2 hours))
- Sensorial thresholds in the NOL-guided group compared to the standard group.(Postoperative Unit (2 hours))
- Persistent pain at three months in the NOL-guided group compared to the standard group.(3 months after surgery)
研究者
Victor Contreras, MSN
Co-Investigador
Pontificia Universidad Catolica de Chile