Comparison of Two Techniques of Ultrasound-guided Sciatic Nerve Block Using Levobupivacaine 0.5% in Orthopedic Surgery at the Hospital Pablo Tobon Uribe - Clínica CES, 2013, Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Latency period of sciatic nerve block.
研究概览
简要总结
The purpose of this study is to evaluate the latency period (timing between the injection of the local anesthetic and the onset of complete sensory nerve block) of two approaches for ultrasound-guided popliteal sciatic nerve block: One of the approaches is the injection of the anesthetic just at the site of the bifurcation of the sciatic nerve and the other one is injecting the local anesthetic at least 2 cm beyond the bifurcation of the aforementioned nerve. Our main hypothesis is that the first approach will decrease the latency period, and probably, will increase the success rate of the nerve block as well as patient satisfaction.
详细描述
Compare the effectiveness of nerve blockade at the bifurcation site of the sciatic nerve versus distal (tibial and peroneal) using only levobupivacaine 0.5%. The primary outcome is the latency period of the nerve blockade; the secondary outcomes are rate of success of the procedure as well as patient satisfaction.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for ankle or foot surgery at Hospital Pablo Tobón Uribe and Clínica CES.
- •Physical status classification of the American Society of Anesthesiologists (ASA) 1-
- •Age: 18-70 years.
- •Weight: 40-100 kg
- •Taller than 140 cm.
排除标准
- •No patient acceptance.
- •Contraindications for nerve block (coagulopathy, local anesthetics allergy, sepsis, infection at the site of puncture).
- •Neuropathy or myopathy affecting the lower limb.
- •Psychiatric or neurological diseases that alter the evaluation of patient.
- •Arrhythmias.
- •Heart failure.
- •Diabetes Mellitus.
- •Pregnancy.
- •Language barriers.
- •Anticoagulation.
研究组 & 干预措施
Sciatic nerve blockade at bifurcation
Ultrasound-guided block at the bifurcation of the sciatic nerve
干预措施: Sciatic nerve anesthesia blockade at bifurcation. (Procedure)
Sciatic nerve blockade at bifurcation
Ultrasound-guided block at the bifurcation of the sciatic nerve
干预措施: Insulated Needle, (Stimuplex; Braun, Melsungen, Germany) (Device)
Sciatic nerve blockade at bifurcation
Ultrasound-guided block at the bifurcation of the sciatic nerve
干预措施: supplemental oxygen (Drug)
Sciatic nerve blockade at bifurcation
Ultrasound-guided block at the bifurcation of the sciatic nerve
干预措施: Midazolam (Drug)
Sciatic nerve blockade at bifurcation
Ultrasound-guided block at the bifurcation of the sciatic nerve
干预措施: Intravenous analgesics (Drug)
Sciatic nerve blockade at bifurcation
Ultrasound-guided block at the bifurcation of the sciatic nerve
干预措施: Saphenous nerve block (Procedure)
Sciatic block 2 cm beyond bifurcation
Ultrasound-guided block of the sciatic nerve 2 cm beyond of the bifurcation
干预措施: Sciatic nerve blockade 2 cm beyond the bifurcation (Procedure)
Sciatic block 2 cm beyond bifurcation
Ultrasound-guided block of the sciatic nerve 2 cm beyond of the bifurcation
干预措施: Insulated Needle, (Stimuplex; Braun, Melsungen, Germany) (Device)
Sciatic block 2 cm beyond bifurcation
Ultrasound-guided block of the sciatic nerve 2 cm beyond of the bifurcation
干预措施: supplemental oxygen (Drug)
Sciatic block 2 cm beyond bifurcation
Ultrasound-guided block of the sciatic nerve 2 cm beyond of the bifurcation
干预措施: Midazolam (Drug)
Sciatic block 2 cm beyond bifurcation
Ultrasound-guided block of the sciatic nerve 2 cm beyond of the bifurcation
干预措施: Intravenous analgesics (Drug)
Sciatic block 2 cm beyond bifurcation
Ultrasound-guided block of the sciatic nerve 2 cm beyond of the bifurcation
干预措施: Saphenous nerve block (Procedure)
结局指标
主要结局
Latency period of sciatic nerve block.
时间窗: 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes and 30 minutes after nerve block.
Once the nerve blockade is done, a sensory evaluation will be performed in the surgical area every five minutes to determine the onset of the sensory nerve blockade in minutes.
次要结局
- Success of sciatic nerve block(Every 5 minutes until 30 minutes until the end of the procedure for the nerve block; an additional measure will be performed at the end of of the surgery.)
- Patient satisfaction(Postoperative 24 hours)
- Sensory block(5, 10, 15, 20, 25 and 30 minutes after the block is finished)
- Motor block(5, 10, 15, 20, 25 and 30 minutes of completion after the block is finished)
- First analgesic(5 minutes, 30 minutes, 24 hours postoperative)
- Visual analog scale at rest(5 minutes, 30 minutes, 24 hours postoperative)
- Dynamic visual analog scale(5 minutes, 30 minutes, 24 hours postoperative)
- Intraneural injection(At the time of injection and execution of the block)
- Vascular puncture(During the execution of the block)
- Paresthesia during the procedure(At the time of the execution of the block)
- Systemic toxicity of local anesthetics(During the execution of the block and 30 minutes after it)
- Hematoma(During and inmmediately after the execution of the block)
- Muscle weakness(24 hours postoperative)
- Altered sensitivity(24 hours postoperative)
- Cramps postoperative(24 hours postoperative of the block)
- Punctures(During the block)
- Time for the execution of nerve block(In minutes: Time from placement of the transducer for the initial scan to final withdrawal of the needle)
研究者
Marta Inés Berrío Valencia
Anesthesiologist
CES University