Does Interneural Local Anesthetic Spread at the Site of Sciatic Nerve Bifurcation Shorten Block Onset Time?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Block onset Time
研究概览
简要总结
Following foot and ankle surgery, ultrasound-guided sciatic nerve block (SNB) at the popliteal fossa decreases post-operative pain and opioid consumption. At the popliteal fossa, the sciatic nerve bifurcates to form the Common Peroneal Nerve (CPN) and Tibial Nerve (TN). Studies have shown that when both branches are blocked separately distal to the bifurcation site, block onset time is reduced by 30%. Through clinical observation, the investigators found that onset time is further shortened when ultrasound-guided SNB is performed at the site of bifurcation. This is because the local anesthetic spreads interneurally. The purpose of this study is to compare the block onset time of an ultrasound-guided sciatic nerve block at the site of nerve bifurcation with the blockade of each terminal nerve separately (TN and CPN) distal to sciatic nerve bifurcation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA physical status I-III
- •18-85 years of age, inclusive
- •50-120 kg, inclusive
- •150 cm of height or greater
排除标准
- •Contraindications to sciatic nerve block (e.g., allergy to local anesthetics, coagulopathy, malignancy or infection in the popliteal area)
- •Significant peripheral neuropathy or neurological disorder affecting the lower extremity
- •Pregnancy
- •History of alcohol or drug dependency/abuse
- •History of significant psychiatric conditions that may affect patient assessment
研究组 & 干预措施
Distal
Blockade of both terminal branches of Sciatic nerve separately, distal to bifurcation
干预措施: Distal (Procedure)
Interneural
sciatic nerve blockade at the site of bifurcation
干预措施: Interneural (Procedure)
结局指标
主要结局
Block onset Time
时间窗: every 5 minutes up to 45 minutes of the block or until surgery starts
We aim to compare the block onset time of an ultrasound-guided sciatic nerve block at the site of nerve bifurcation resulting in interneural spread of local anesthetic with that of blockade of each terminal nerve separately (TN and CPN), distal to sciatic nerve bifurcation. We hypothesize that sciatic nerve blockade at the site of bifurcation with interneural local anesthetic spread within a common epineural sheath results in shorter onset time compared to blockade of each terminal nerve distal to sciatic nerve bifurcation.
次要结局
- Extent of longitudinal local anesthetic solution spread(starting at block administration till 5 minutes after complete injection)
- Nerve diameter prior to and following injection(starting at block administration till 5 minutes after complete injection)
- Block procedure time(starting at block administration till complete injection(up to 10 minutes))
- Number of skin punctures required.(starting at first attempt of block administration till complete injection(up to 10 minutes))
- Block success rate(starting after complete injection up to 45 minutes)
- Incidence of block-related complications(immediately , at 24 hours and Post operative day 7)
- Postoperative pain(starting at patient's arrival at post-anesthetic care unit till 120 minutes)