Effect of Leg Positioning and Tourniquet Inflation on Onset and Duration of Ultrasound Guided Sciatic Nerve Block After Injection of Local Anesthetic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Evaluation of motor block evaluated by measuring movement on the scale of 0 to 5 as compared to the other foot.
研究概览
简要总结
The primary purpose of this study is to determine whether the leg positioning or distal tourniquet used during the injection of local anesthetic may decrease the onset time and prolong the duration of analgesia of ultrasound-guided Sciatic Nerve Block (SNB) with popliteal approach. Patients will be divided randomly into three groups: group 1 will receive sciatic nerve block, with leg kept in a neutral position after anesthesia (control group); group 2 will receive the same anesthesia, with leg raised 30° by placing the back of the foot over a support placed on the OR table and maintained in that position for 15 min; and patients in group 3 will receive the same anesthesia, and distal tourniquet placed on the lower part of the leg (upper part of the tourniquet being about 4-6 inches from the ankle) with the leg in a neutral position
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing elective foot surgery under ultrasound guided popliteal sciatic/saphenous block
- •American Society of Anesthesiologist physical status 1-3, meaning patients who are either completely or their systemic disease(s), if they have is (are) under control with medications or other means.
- •Have capacity to provide informed consent.
排除标准
- •clinically significant coagulopathy (impaired blood clotting)
- •infection at injection site
- •allergy to local anesthetics
- •severe cardiopulmonary disease (heart and lung disease)
- •body mass index >35 kg.m2
- •known neuropathies (degenerative, infectious and traumatic peripheral nerve diseases)
- •who are receiving opioids for chronic analgesic therapy at the time of contemplated surgery
- •Patients with history of AIDS, tuberculosis, and other infections
- •active and/or unstable cardiac, renal, pulmonary and neurologic disorders will be excluded from the study. This includes patients in heart failure having limited exercise ability, end stage renal failure on dialysis treatment, recent stroke etc.
- •Vulnerable subjects (children, pregnant subjects, prisoners, mentally impaired) also will not be included in the study.
- •Subjects who do not understand or speak English
研究组 & 干预措施
Distal tourniquet placed on the lower part of the leg
Sciatic nerve block, and distal tourniquet placed on the lower part of the leg (upper part of the tourniquet being about 4-6 inches from the ankle) with the leg in a neutral position.
干预措施: Sciatic Nerve block (Other)
Leg in a neutral position
Sciatic nerve block, with leg kept in a neutral position after anesthesia (control group)
干预措施: Sciatic Nerve block (Other)
Leg in a neutral position
Sciatic nerve block, with leg kept in a neutral position after anesthesia (control group)
干预措施: Leg in a neutral position (Other)
Leg raised 30°
Sciatic nerve block, with leg raised 30° by placing the back of the foot over a support placed on the OR table and maintained in that position for 15 min
干预措施: Sciatic Nerve block (Other)
Leg raised 30°
Sciatic nerve block, with leg raised 30° by placing the back of the foot over a support placed on the OR table and maintained in that position for 15 min
干预措施: Leg raised 30° (Other)
Distal tourniquet placed on the lower part of the leg
Sciatic nerve block, and distal tourniquet placed on the lower part of the leg (upper part of the tourniquet being about 4-6 inches from the ankle) with the leg in a neutral position.
干预措施: Distal tourniquet placed on the lower part of the leg (Other)
Distal tourniquet placed on the lower part of the leg
Sciatic nerve block, and distal tourniquet placed on the lower part of the leg (upper part of the tourniquet being about 4-6 inches from the ankle) with the leg in a neutral position.
干预措施: Leg in a neutral position (Other)
结局指标
主要结局
Evaluation of motor block evaluated by measuring movement on the scale of 0 to 5 as compared to the other foot.
时间窗: 15 Minutes
Level of pain measured on a scale of 0 to 10 (0 being no pain; 10 being most pain) prior to first pain killer
时间窗: 15 Minutes
Evaluation of Sensory block by measuring decrease in sensation on the scale of 0 to 5 (0 being no sensation; 5 being most sensation) as compared to the other foot.
时间窗: 15 Minutes
次要结局
未报告次要终点