Risk-benefit analysis of intrathecal morphine administration to patients undergoing surgical treatment of proximal femoral fracture (monocentric, single-blinded, randomized clinical study compared to standard treatment)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- pain assessment using VAS10 at rest (value 0-10 according to pain intensity, measured every 2 h for 24 h)
研究概览
简要总结
To verify that intrathecal administration of morphine results in better patient analgesia than administration of opioids by other routes.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •ASA classification I - III
- •patient indicated for procedure in subarachnoid block
- •signed informed consent form
排除标准
- •patient allergic to opioid analgesics
- •the assumption of a high risk of postoperative respiratory depression
- •procedure under general anaesthesia
结局指标
主要结局
pain assessment using VAS10 at rest (value 0-10 according to pain intensity, measured every 2 h for 24 h)
pain assessment using VAS10 at rest (value 0-10 according to pain intensity, measured every 2 h for 24 h)
pain assessment using VAS10 while positioning the patient
pain assessment using VAS10 while positioning the patient
time until the first administration of rescue medication – analgesics
time until the first administration of rescue medication – analgesics
total consumption of opioids in the ICU per 24 h
total consumption of opioids in the ICU per 24 h
the dose of administered non-opioid analgesics
the dose of administered non-opioid analgesics
次要结局
- monitoring of hypoventilation
- monitoring of hypotension
- monitoring of bradycardia
- postoperative nausea and vomiting
- effect of antiemetic mediation
- monitoring of pruritus
- the effectiveness of the treatment of pruritus
研究者
Denis Buršík
Scientific
Fakultni Nemocnice Ostrava