Intraoperative Sufentanil and Chronic Postsurgical Pain in Non-major Scheduled Abdominal Surgery
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 855
- 试验地点
- 2
- 主要终点
- Incidence of CPSP
研究概览
简要总结
Several risk factors for chronic postoperative pain have been identified. A series of studies have shown that administrating intraoperatively a high dose of Remifentanil is associated with an increased incidence of CPSP. These findings highlight a risk factor for CPSP that the anaesthetist can influence on, but they however remain limited to remifentanil. To this day, no study have attempted to evaluate the existence of such an association between the incidence of CPSP and the intraoperative administration of sufentanil doses. Improved knowledge of the long-term nociceptive impact of intraoperative sufentanil administration would enable better therapeutic adaptation according to each patient's risk.
In the field of CPSP, non-major abdominal surgeries remain poorly studied. This is due to their lower risk of CPSP than other surgeries such as orthopaedic, mammary or thoracic surgery. Nevertheless, they constitute a large number of daily surgical procedures. The estimated incidence of CPSP in non-major abdominal surgery appears in several studies to be between 15 and 20% The aim of this study is to evaluate the correlation between the intraoperative administration of sufentanil doses and the incidence of CPSP at 3 months in patients undergoing non-major scheduled abdominal surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Age > 18 years old.
- •Non-major scheduled abdominal surgery.
- •Patient will receive Sufentanil intraoperatively for induction and maintenance of general anesthesia
- •Written or oral informed consent to participate in the study.
排除标准
- •Intraoperative complications that are life-threatening or require the surgical procedure to be discontinued.
- •Repeat surgery at the same surgical site in less than 3 months.
- •Pregnancy.
- •Ambulatory surgery.
- •Endoscopic surgery.
- •Surgery with loco-regional or perimedullary anesthesia without general anesthesia
- •Intraoperative use of an opioid other than Sufentanil.
- •Hypersensitivity to sufentanil
- •Legally protected patients (under judicial protection, guardianship, curatorship).
- •Patients suffering from psychiatric pathologies.
- •Patients suffering from neurodegenerative pathologies.
- •Patients for whom self-assessment of pain using an numerical rating scale (0-10) is not feasible (language barrier, etc…)
结局指标
主要结局
Incidence of CPSP
时间窗: at 3 months
Incidence of CPSP at 3 months after non-major scheduled abdominal surgery
次要结局
- Post-operative pain intensity(at 48 hours)