Dual Guidance in Regional Anesthesia
- Conditions
- Anesthesia; Adverse EffectAnesthesia, LocalAnesthesia
- Registration Number
- NCT03383770
- Lead Sponsor
- Charite University, Berlin, Germany
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- Presence of the written declaration of consent
- Age of at least 18 years
- No participation in another intervention study during participation
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Ultrasound distance 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.
- Secondary Outcome Measures
Name Time Method Visibility_1 duration of blockade, an average of 15 minutes Ultrasound visibility of needle
Impedance duration of blockade, an average of 15 minutes Impedance measured by nerve stimulator while progressing the needle
Visibility_2 duration of blockade, an average of 15 minutes Ultrasound visibility of nerve
Effect_sensoric duration of surgery and recovery unit, an average of 120 minutes Effectiveness of the blockade measured by temperature sensibility testing on the food
Effect_motor duration of surgery and recovery unit, an average of 120 minutes Effectiveness of the motor blockade measured by possible movement of the foot
Trial Locations
- Locations (1)
Charité - Universitätsmedizin Berlin Campus Charité Mitte
🇩🇪Berlin, Deutschland, Germany
Charité - Universitätsmedizin Berlin Campus Charité Mitte🇩🇪Berlin, Deutschland, Germany