Comparison of Spinal Morphine With Systemic Analgesia After Urologic Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Duration of analgesia
研究概览
简要总结
The study was performed in urology patients elicited for open prostatectomy or open nephrectomy. Comparison of analgesic effect between group (M) with spinal morphine before general anaesthesia and group without this intervention was measured.
详细描述
Patients elicited for open prostatectomy or open nephrectomy were randomly divided in 2 groups. Group M were administered preservative-free morphine 250 mcg in 2.5 ml NS intrathecal using 25 G needle in L1/2 - L5/S1 interspaces. Control group (C) were given no intervention. Placebo intrathecal injection in C was not used because of ethical reason. Standard general anaesthesia was used in both groups. After surgery all patients were transferred to urology ICU and were given standard analgesic regimen according to level of pain measured by numeric rating scale (NRS) 0 - 10: NRS > 3 metamizol 1 g IV every 6 h., max. 4 g/24 h., NRS > 3 paracetamol 1g IV every 6 h., max. 4 g/24 h., NRS > 3 lasting 30 min. after administration of previous ones diclofenac 75 mg IM á 12 h., max. 150 mg/24 h., NRS > 4 morphine 10 mg SC á 6 h. Personnel of ICU was blinded to the analgesic method used.
Noticed parameters: pain intensity (NRS), time to NRS ≥ 4, time to the first morphine request, side effects (respiratory rate <8, SpO2<90 %, nausea, vomiting, naloxone administration for SpO2<88 %, itching).
Standard statistical analysis was used, p value < 0.05 was considered significant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Only ICU personnel was blinded to the method used
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Morphine group M
Experimental group M were administered preservative-free morphine 250 mcg in 2.5 ml NS intrathecal using 25 G needle in L1/2 - L5/S1 interspaces.
干预措施: Morphine (Drug)
结局指标
主要结局
Duration of analgesia
时间窗: 48 hours
Time to the first morphine request during the first two days of ICU stay after surgery (in hours) and total morphine consumption during the first two days of ICU stay (in mg)
次要结局
- Morphine side effects(48 hours)
研究者
Jiri Malek
Assoc. Prof., M.D., Ph.D.
Charles University, Czech Republic
