Does Preoperative Midazolam Dose Affect Postoperative Pain? - a Multicentric Observational Study in Open Inguinal Hernia Repair
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 4
- 主要终点
- Postoperative pain
研究概览
简要总结
To investigate whether midazolam has any effect on postoperative pain in outpatient surgery, the investigators will assess the impact of different midazolam doses on pain scores 24h, 7 days and 3 months after open inguinal hernia repair.
The investigators hypothesize that patients being administered higher midazolam doses will refer more pain.
详细描述
Systemic midazolam prescribed perioperatively might have impact on pain, with studies suggesting antinociceptive and hyperalgesic effects. Anxiety might be a confounder in this association. In order to investigate the effect of midazolam on postoperative pain, a prospective cohort study will be conducted in four Portuguese ambulatory surgery units. A convenience sample with consecutive design will include patients admitted for open inguinal hernia repair. After anxiety and pain evaluation, a tailored dose of midazolam will be administered as premedication according to the anesthetist's best judgement within each unit's protocol (routine care; this dose may be null). Subsequent anesthesia and analgesia will be standardized. Postoperative pain will be blindly assessed by telephone interviews at 24h, 7 days, and 3 months. Statistical analysis will be performed separately for each gender, centre and type of anesthesia, adjusting for preoperative anxiety and other confounding variables with multivariate analysis.
The investigators intend to clarify the relation between anxiety, preoperative midazolam and postoperative pain.
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
- •adults proposed for open inguinal hernia repair in Portuguese ambulatory surgery units
排除标准
- •psychiatric disorders
- •alcoholism
- •illiteracy or poor understanding of the Portuguese language
- •history of chronic pain under opioids
- •recurrent surgery
结局指标
主要结局
Postoperative pain
时间窗: 24h after surgery
Pain numeric rating scale (NRS) 0-10
次要结局
- Global surgery recovery index(3 months after surgery)
- Patient satisfaction(3 months after surgery)
- Postoperative pain(3 months after surgery)
- Analgesic consumption(7 days after surgery)
- Adverse events(7 days after surgery)
研究者
Caroline Dahlem
Principal Investigator
Universidade do Porto