Comparison Between Pre-operative Prescription Delivered During Anesthesia Consultation or Post-operative Prescription: a Randomized Prospective Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Early home pain after ambulatory surgery
研究概览
简要总结
This study evaluates the comparison of the incidence of postoperative home pain after ambulatory surgery with general anesthesia between a group with pre-surgical prescription delivered during anesthesia preoperative clinic and a group with postoperative prescription.
详细描述
The ambulatory surgery increased over the last twenty years in France. The management of home pain after ambulatory surgery is a major challenge because it is the principal complication after day surgery with several consequences: nausea and vomiting, chronic pain, functional impairment with handicap, sleeping troubles, extra-hospital consultation. Management of home pain remains currently could be performed in ambulatory surgery. The French Society of Anesthesiology recommends to deliver pre-surgical prescription during the preoperative anesthesia clinic but this guideline is not bases on evidence in the literature. Also, we have previously shown in a retrospective non-randomized work a decrease of postoperative home pain in patient with general anesthesia. The main objective of this controlled and comparative study is to compare the incidence of postoperative home pain after ambulatory surgery with general anesthesia between a group with pre-surgical prescription delivered during anesthesia consultation and a group with postoperative prescription.
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
- 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
- 是
入选标准
- •Any major ambulatory surgery patient with general anesthesia.
排除标准
- •Pregnancy.
- •Minor patient.
- •ASA score >
- •lack of general anesthesia.
- •General anesthesia combined with locoregional anesthesia.
- •Contraindication to ambulatory surgery.
- •Chronic pain.
- •chronic analgesic consumption.
- •no indication of non steroidal anti-inflammatory drug, paracetamol with codeine and morphine.
- •Active or old drug addiction.
- •Cognitive disorders or dementia.
- •Serious psychiatric disorders.
- •Patient under curatorship or tutorship.
- •No social protection
- •Misunderstanding of the French language
- •Patient participating in another trial
研究组 & 干预措施
Pre-operative prescription group
This group will have a pre-operative prescription delivered during the preoperative anesthesia clinic.
干预措施: Comparison between pre-operative prescription and post-operative prescription (Other)
Postoperative prescription group
This group will receive the postoperative prescription.
干预措施: Comparison between pre-operative prescription and post-operative prescription (Other)
结局指标
主要结局
Early home pain after ambulatory surgery
时间窗: 24 hours after ambulatory surgery
The primary outcome is the incidence of at least one home pain experience with intensity greater than 3 on a scale from 0 to 10 within 24 hours after surgery.
次要结局
- Intense painful experience during hospitalisation(Day 1)
- Low painful experience during hospitalisation(Day 1)
- Low home pain experience(Within 7 days after ambulatory surgery)
- Intense home pain experience(Within 7 days after ambulatory surgery)
- Adherence to analgesic treatment(Within 7 days after ambulatory surgery)
- Patient's satisfaction(Within 7 days after ambulatory surgery)
- Use of morphine analgesics(Within 7 days after ambulatory surgery)
- Low home pain experience(24 hours after ambulatory surgery)