Block Duration After Spinal Block and iv Dexamethasone: a Randomized Controlled Double-blinded Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Duration of sensory block (minutes)
研究概览
简要总结
It has been largely demonstrated that iv dexamethasone prolongs the duration of analgesia after peripheral nerve block. However, data are missing regarding the duration of analgesia after spinal block. The objective of this randomized controlled double-blinded trial is to assess whether intravenous dexamethasone administered after a spinal block, before the surgery would prolong sensory block characteristics without impacting the motor block duration.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Patient with ASA I-III status ;
- •Patient scheduled for an osteosynthesis surgy of the lower limb
排除标准
- •Polytrauma patient
- •Pregnancy
- •Contraindication to spinal anesthesia
- •Contraindication to dexamethasone administration
- •Patient with chronic pain
研究组 & 干预措施
Dexamethasone
Intravenous injection of 0.15 mg/kg of dexamethasone before the surgery.
干预措施: Dexamethasone (Drug)
Placebo
Intravenous injection of NaCl 0,9% before the surgery.
干预措施: NaCl 0.0308 MEQ/ML Injectable Solution (Drug)
结局指标
主要结局
Duration of sensory block (minutes)
时间窗: Postoperative day 0
Time interval between injection of the local anaesthetic and the regression of 2 dermatoma, compared to the highest dermatoma reached
次要结局
- Total duration of the sensory block (minutes)(Postoperative day 0)
- Highest dermatoma reached (level)(Postoperative day 0)
- Total duration of the motor block (minutes)(Postoperative day 0)
- Rate of postoperative nausea and vomiting(Postoperative day 0, 1 and 2)
- Time to the first analgesic request (minutes)(Postoperative day 0)
- Pain score(Postoperative days 0, 1 and 2)
- Length of stay(up to 14 days)
- Cumulative consumption of morphine (mg)(Postoperative days 0, 1 and 2)
- Onset time between injection and highest dermatoma (minutes)(Postoperative day 0)
- Rate of pruritus(Postoperative day 0, 1 and 2)
- Rate of urinary retention(Postoperative day 1 and 2)
- Satisfaction level(Postoperative day 2)
- Persistent pain(3 and 6 postoperative months)
- Pain score if persistent pain(3 and 6 postoperative months)
研究者
Eric Albrecht
Program director of regional anaesthesia
Centre Hospitalier Universitaire Vaudois