Pain Intensity After RObotic Assisted Urological Surgery: the PAIROU Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 968
- 试验地点
- 46
- 主要终点
- Pain level on D1 of surgery
研究概览
简要总结
Postoperative pain remains a widespread but still underestimated problem. Studies have shown that despite improvements in pain management, many patients still suffer from moderate to severe postoperative pain. Severe pain is associated with decreased patient satisfaction, delayed postoperative ambulation, prolonged length of stay, risk of developing chronic postoperative pain, and increased morbidity and mortality. Therefore, it is of great importance that surgical procedures that result in severe pain and the optimal analgesic strategies for these procedures can be identified. Most recommendations on postoperative pain management (prevention and treatment) are not procedure-specific. However, risk factors for postoperative pain depend on the patient and the procedure.
In order to develop procedure-specific postoperative pain management guidelines, pain must be assessed in a procedure-specific manner. Additionally, data is sparse on relatively new procedures like robotic surgery. A study, Harel et al. compared pain intensities after ureteral reimplantation with robotic or open surgery in children and reported lower pain scores after robotic surgery. This single study reinforces the clinical findings that robotic surgery is associated with less pain. However, pain assessment after robotic urologic surgery has not been evaluated before.
In order to add to the evaluation of postoperative pain in different surgical groups, we wish to evaluate pain intensities after robot-assisted urological surgery. In this cohort study, we seek to provide an estimate of the pain intensities that can be expected after most types of robot-assisted urological surgery in relation to analgesic treatment.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Age > or = 18 years old
- •Programmed robot-assisted urological surgery
- •Patient who did not declare any opposition to participating in the study
排除标准
- •Urgent surgery
- •Impossibility of communicating in French
- •Cognitive deficit
- •Adults legally protected or deprived of liberty
结局指标
主要结局
Pain level on D1 of surgery
时间窗: Day 1 after surgery
Measurement of pain intensity on D1 of surgery, assessed with a simple numerical scale (ENS). Scores range from 0-10 points, with higher scores indicating greater pain intensity.
次要结局
- Presence of side effect: Nausea and vomiting(In the first 48 hours)
- Highest pain score at rest and during exercise(In the first 48 hours)
- Time of the first ambulation(Time of the first ambulation during hospitalization)
- Pain intensity (NRS) at rest and during exercise(Second day after surgery)
- Complications(Period is defined from the day of robotic assisted urological surgery until the end of hospitalisation)
- Length of stay(From the first day of hospitalization to the last day of hospitalization)
- Date and time of resumption of transit(Date and time of resumption of transit)
- Consumption of morphine(During the 48 hours after surgery)
- Duration of surgery(Duration of surgery)
- Operator experience for the robotic assisted urological surgery(Operator experience is the number of years from the first robotic assisted urological surgery performed by the operator until the surgery of the patient included in this study.)