Ultrasound-guided Popliteal Sciatic Nerve Block: an Evaluation of the Intraneural
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Evaluation of the Intraneural Ropivacaine Minimal Effective Volume in 90% of patients (MEV90)
研究概览
简要总结
This prospective, double-blinded study evaluates intraneural ropivacaine 1% Minimal Effective Volume (MEV90) for ultrasound-guided (US) popliteal sciatic nerve block, with Up-and-down methodology.
To evaluate any neurological complications, an electrophysiological assessment will also be performed preoperatively and at 5 weeks after surgery.
详细描述
At least 45 patients undergoing hallux valgus repair will be enrolled. A baseline bilateral sciatic nerve electrophysiological study will be performed preoperatively.
Patients will be placed in prone position and a high-frequency (8-12 MHz) linear array transducer (Snerve, Sonosite, USA) will be used to identify the sciatic nerve in a transverse cross-sectional view at the apex of the popliteal fossa. As the best view of the sciatic nerve with its paraneural and neural sheath, just proximal to the point of bifurcation, will be obtained, the nerve dimension (medial-lateral and cranio-caudal diameters) will be determined and registered.
An 80 mm 22-gauge needle (Sonoplex, Pajunk, Germany) will be inserted using the US-guided in-plane technique under the epineurium. The positioning will be evaluated injecting 1 ml of sodium-chloride 0.9% solution and observing the nerve swelling, if correct the local anaesthetic (LA) solution will be injected.
The first patient will receive 15 ml of ropivacaine 1% (150 mg). Following patients will receive LA volume based on Up-and-down methodology.
Clinical follow-up will be performed at 12, 24, 48 hours, 1 and 5 weeks and 6 months after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age above 18 years old
- •ASA I-III
- •Signed informed consensus
排除标准
- •Unstable neurological disease
- •DM type I-II
- •Allergy to ropivacaine-mepivacaine
- •Opioid chronic treatment
- •Consensus refusal or not valid
- •Rheumatoid arthritis
- •Baseline electrophysiological study positive finding
- •Postoperative intensive care required
研究组 & 干预措施
Intraneural
Using an Up-and-down methodology, the first patient receives 15 ml ropivacaine 1% intraneural injection. If unsuccessful, following patient will receive an increased dose of LA (2 ml). If successful, following patient will be randomized to have either the same LA dose (9 out of 10 probability) or 2 ml reduction of LA dose (1 out of 10 probability)
干预措施: intraneural sciatic nerve injection (Procedure)
Intraneural
Using an Up-and-down methodology, the first patient receives 15 ml ropivacaine 1% intraneural injection. If unsuccessful, following patient will receive an increased dose of LA (2 ml). If successful, following patient will be randomized to have either the same LA dose (9 out of 10 probability) or 2 ml reduction of LA dose (1 out of 10 probability)
干预措施: Ropivacaine 1% (Drug)
结局指标
主要结局
Evaluation of the Intraneural Ropivacaine Minimal Effective Volume in 90% of patients (MEV90)
时间窗: 6 months
次要结局
- electrophysiological assessment of neurological deficit(5 weeks)
研究者
Gianluca Cappelleri
MD
ASST Gaetano Pini-CTO