2024-510569-41-00招募中4 期
The effects of various concentrations of ropivacaine on the onset and duration of ultrasound-guided ankle blocks in patients undergoing hallux valgus repair surgery – a randomized, double-blinded, parallel-group interventional study
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- The primary endpoint is the difference in the duration of the sensory blocks.
研究概览
简要总结
To compare the duration of the sensory block in patients having hallux valgus repair surgery under ankle block with 0.25%, 0.5%, and 1% ropivacaine over a 48-hour period.
研究设计
- 分配方式
- Randomized
- 主要目的
- Treatment groups
- 盲法
- Double (Subject, Investigator, Analyst)
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
- •Provide signed consent and dated informed consent
- •Age 18 up to and including 75 years, scheduled for elective forefoot surgery for hallux valgus repair under unilateral ankle block at ZOL Genk
- •American Society of Anesthesiologists (ASA) physical status I-II-III
- •Able to ambulate (ability to walk independently, without assistive devices)
- •Able to learn and perform study sensory and motor assessment by exhibiting sensitivity to pinprick, cold, and light touch (tested beforehand with pinprick, cold, light touch sensation test) as the patient will have to perform these sensory and motor assessments by themselves at home at postoperative days 0 to 2
排除标准
- •Language barrier
- •Preexisting lower extremity neuropathy
- •Contraindications to ankle block (local infection, edema, burn, soft tissue trauma, or distorted anatomy with scarring in the area of block placement)
- •Contraindications for use of non-steroidal anti-inflammatory drugs (NSAIDs)
- •Allergy to local anesthetics
- •Uncontrolled anxiety, psychiatric or neurological disorder that might interfere with study assessment
- •Weight below 50 kg (based on a maximum dose of 3 mg/kg ropivacaine and a maximum dose of 150 mg ropivacaine)
- •Preoperative use of opioids or gabapentin less than 3 days before surgery
结局指标
主要结局
The primary endpoint is the difference in the duration of the sensory blocks.
The primary endpoint is the difference in the duration of the sensory blocks.
次要结局
- The difference in onset time of the sensory block.
- The difference in motor function.
- The difference in postoperative pain scores (analgesia).
- The difference in opioid consumption.
研究者
Clinical Trial Unit
Scientific
Ziekenhuis Oost Limburg
研究点 (1)
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