Dual Guidance in Regional Anesthesia

Not Applicable

Completed

• Conditions: Anesthesia; Adverse Effect; Anesthesia, Local; Anesthesia
• Interventions: Procedure: Regional Anesthesia Facet; Procedure: Regional Anesthesia Touhy

• 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.

Study Timeline

• Study First Submitted: 2017-12-14
• Study First Submitted QC: 2017-12-19
• Study First Posted: 2017-12-26
• Study Start: 2018-02-05
• Primary Completion: 2019-09-15
• Study Completion: 2019-09-15
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-21
• Last Update Posted: 2022-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Presence of the written declaration of consent
• Age of at least 18 years
• No participation in another intervention study during participation

Exclusion Criteria

• 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

Arm && Interventions

Group	Intervention	Description
Facet	Regional Anesthesia 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.
Tuohy	Regional Anesthesia Touhy	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.

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