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
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Pain assessment
研究概览
简要总结
The aim of the study is to investigate postoperative pain relief for patients undergoing surgical treatment of proximal femoral fracture using intrathecal administration of morphine.
详细描述
In this study, the investigators will compare the efficiency of intrathecal morphine administration with the standard of care (parenteral application of analgesics) for pain relief in patients after proximal femoral fracture surgery. The secondary outcome measure will be to determine the frequency of adverse effects of intrathecally administered morphine. The study will be monocentric, randomized, and single-blinded. A total of 50 patients are expected to be enrolled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
The participant will not know which arm of the study he/she has been enrolled into.
入排标准
- 年龄范围
- 60 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •signed informed consent
- •60 to 90 years of age
- •surgical treatment of proximal femur fracture
- •The American Society of Anesthesiologists (ASA) classification I to III
- •spinal anesthesia used for the operation
排除标准
- •general anesthesia used for the operation
- •allergy to opioids
- •high risk of respiratory depression
研究组 & 干预措施
Intrathecal morphine administration
Study subjects randomized into this arm will be administered morphine intrathecally in the dose of dose 100 ug.
干预措施: Intrathecal morphine administration (Drug)
Parenteral administration of analgesics
Study subjects randomized into this arm will receive standard postoperative pain management (parenteral administration of analgesics).
干预措施: Parenteral administration of analgesics (Drug)
结局指标
主要结局
Pain assessment
时间窗: Every 2 hours after the surgery, total of 24 hours
Pain intensity will be assessed using the Visual Analogue Scale (VAS10) scale (0-10). The total value of all measured values will be calculated. The maximum value observed during the 24 hours will be also recorded.
Pain assessment during patient positioning
时间窗: 24 hours
Pain intensity will be assessed using the VAS10 scale (0-10) during the positioning of the patient.
Time to administration of rescue medication
时间窗: 24 hours
The time to administration of rescue medication (analgesics) will be observed in hours.
Total consumption of opioids on Intensive Care Unit
时间窗: 24 hours
The total consumption of opioids on Intensive Care Unit will be measured in the number of administered doses.
次要结局
- Hypotension(24 hours)
- Bradycardia(24 hours)
- Postoperative nausea and vomiting(24 hours)
- Pruritus(24 hours)
- Hypoventilation - bradypnea(24 hours)
- Hypoventilation - presence of hypopnea (TV < 4)(24 hours)
- Hypoventilation - SpO2(24 hours)
- Hypoventilation - presence of hypoxemia (paO2) (below 10 kPa)(24 hours)
- Hypoventilation - other signs of respiratory insufficiency(24 hours)
- Effect of antiemetics(24 hours)
- Effect of pruritus treatment(24 hours)