Dual Guidance in Regional Anesthesia - Prospective Randomized Study of Needle-nerve Distance in Different Cannulas for Regional Nerve Blockade
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Ultrasound distance
研究概览
简要总结
Regional anaesthesia is a frequently used procedure. Currently, blockades are increasingly carried out without nerve stimulation. The risk of nerve lesion is about 3 %. Industrial efforts frequently referred to ultrasound optimisation of the regional anaesthesia cannula. In order to optimise patient safety, the benefit of both procedures (stimulation and ultrasound) should be combined and both procedures optimised. In this study, the influence of the needle electrode size on the stimulability of the nerve ischiadicus should be determined.
详细描述
There are various methods of performing regional anesthesia. In recent years, the focus has been on ultrasound-supported regional anaesthesia, and the stimulation methods that were often used in the past were no longer used or used less frequently. The combination of both methods may be an additional safety aspect and can contribute to an improved blocking quality. In addition to the best possible ultrasound quality, an optimal stimulation quality is also required. The investigators plan to carry out dual-guidance blockages of the ischiadic nerve with various regional anaesthesia needles (manufacturer of the used needles: Pajunk Medical Produkte GmbH, Geisingen, Germany; Teleflex Medical GmbH, Kernen, Germany). All regional anaesthesia cannulae are approved for the planned blockades of humans in Germany.
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
- Single (Participant)
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
- •Presence of the written declaration of consent
- •Age of at least 18 years
- •No participation in another intervention study during participation
排除标准
- •present contraindication for the application of regional anesthesia and nerve stimulation
- •Cardiac pacemaker/AICD (Automated internal cardioverter defibrillator) carrier
- •Known allergies to used medicines
- •Patients under 18 years of age
- •Ineligible patients
- •Missing consent
- •Pregnancy/nursing patients
- •Classification of patients into class 4 or higher status according to the American Society of Anesthesiologists
- •Existing nerve damage in the target area
- •Medically treated diabetes mellitus, alcohol abuse or alcohol abuse in the patient's history (using AUDIT)
- •Visibility score of the nerve of 3 or more
- •Participation in another intervention study during participation
- •Accommodation in an institution on the basis of a court or administrative order
研究组 & 干预措施
Tuohy
After a careful disinfection of the puncture site, under sterile conditions and under ultrasonographic control with the application of nerve stimulation (settings: stimulation current primary 2.0 mA with stepwise reduction over 1.0 mA to 0.5 mA, pulse width 0.1 ms, pulse frequency 2 Hz) of the N. ischiadicus blocked by 20 ml ropivacaine 0.75 %. (electrical nerve stimulation and ultrasound) If no motor response can be triggered by stimulation, the closest possible needle-nerve distance is generated at a pulse strength of 1mA and regional anesthesia is performed. (protective nerve stimulation) Subsequently, the transplantation into the supine position and the further procedure specific to the operation (use of other regional procedures in combination or general anaesthesia).
A tuohy needle is used.
干预措施: Regional Anesthesia Touhy (Procedure)
Facet
After a careful disinfection of the puncture site, under sterile conditions and under ultrasonographic control with the application of nerve stimulation (settings: stimulation current primary 2.0 mA with stepwise reduction over 1.0 mA to 0.5 mA, pulse width 0.1 ms, pulse frequency 2 Hz) of the N. ischiadicus blocked by 20 ml ropivacaine 0.75 %. (electrical nerve stimulation and ultrasound) If no motor response can be triggered by stimulation, the closest possible needle-nerve distance is generated at a pulse strength of 1mA and regional anesthesia is performed. (protective nerve stimulation) Subsequently, the transplantation into the supine position and the further procedure specific to the operation (use of other regional procedures in combination or general anaesthesia).
A facet needle is used.
干预措施: Regional Anesthesia Facet (Procedure)
结局指标
主要结局
Ultrasound distance
时间窗: duration of blockade, an average of 15 minutes
Ultrasound-based measurement of needle-nerve distance during the application of the regional anesthesia of the N. ischiadicus during infragluteal access.
次要结局
- Visibility_1(duration of blockade, an average of 15 minutes)
- Impedance(duration of blockade, an average of 15 minutes)
- Visibility_2(duration of blockade, an average of 15 minutes)
- Effect_sensoric(duration of surgery and recovery unit, an average of 120 minutes)
- Effect_motor(duration of surgery and recovery unit, an average of 120 minutes)
研究者
Jurgen Birnbaum
PD Dr. med.; Consultant Anaesthesiologist
Charite University, Berlin, Germany