Effect of the Use of Tourniquet in the Thigh: a Biomechanical Analysis on the Muscular Function of the Quadriceps in the Postoperative Period.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Postoperative muscle dysfunction
研究概览
简要总结
The use of a pneumatic tourniquet with the purpose of maintaining an operative field free of blood is a common practice in orthopedic surgery. Its use is associated with local and systemic consequences related to hemodynamic and reperfusion ischemia phenomena. Although is known that its use is not an innocuous measure, there is still certain degree blurriness regarding the potential metabolic and functional consequences that may result in the involved limb.
In this trial, the investigators are setting out to discriminate the effect of the pneumatic tourniquet on thigh muscle function (strength, tone and activation). The hypothesis is that the pneumatic tourniquet by itself causes a significant postoperative muscular dysfunction of the quadriceps and, thus, the main outcome will be the presence of postoperative quadriceps muscle dysfunction, defined as a fall greater than or equal to 10% of the maximal voluntary isometric contraction measured at 24 hours post surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
Surgical side can not be randomized. Only data assessor will be blinded.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing forefoot surgery that requires the use of a pneumatic tourniquet
- •American Society of Anesthesiologists classification 1-3
排除标准
- •Ambulatory surgery
- •Adults who are unable to give their own consent
- •Pre-existing neuropathy or myopathy
- •Contraindication of tourniquet use
- •Bilateral surgery
- •Pregnancy
- •Hip, thigh, knee, leg or ankle pathologies that prevent or contraindicate using a dynamometer, tonometer or surface electromyographer
- •Arterial hypertension with systolic pressures above 200mmHg
- •Renal failure
- •Hepatic failure
研究组 & 干预措施
Surgical Side
Surgical side requiring the use of a pneumatic tourniquet.
干预措施: Pneumatic tourniquet use (Device)
Non Surgical Side
Contralateral side (Control Thigh).
结局指标
主要结局
Postoperative muscle dysfunction
时间窗: 24 hours
Fall greater or equal than 10% of the voluntary isometric muscle contraction from basal
次要结局
- Postoperative measurements time(24 hours)
- Upper and lower extremity blood pressures after spinal anesthesia(10 minutes after spinal anesthesia)
- Arterial occlusion pressure(10 minutes after spinal anesthesia)
- Basal upper and lower extremity blood pressures(Up to 2 hours pre spinal anesthesia)
- Pneumatic tourniquet inflation pressure(3 hours from tourniquet inflation)
- Pneumatic tourniquet inflation time(3 hours from tourniquet inflation)
- Quadriceps electromyographic activation profile(24 hours)
- Quadriceps muscle tone(24 hours)
- Thigh perimeter(24 hours)
- Thigh pain(24 hours)
研究者
Daniela Bravo Advis
Assistant Professor, Department of Anesthesia
University of Chile