Dual Guidance in Regional Anesthesia

Dual Guidance in Regional Anesthesia - Prospective Randomized Study of Needle-nerve Distance in Different Cannulas for Regional Nerve Blockade

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia, Local; Anesthesia; Anesthesia; Adverse Effect
• Intervention / Treatment: Procedure: Regional Anesthesia Touhy; Procedure: Regional Anesthesia Facet

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Deutschland
    • Berlin, Deutschland, Germany, 10115
      • Charité - Universitätsmedizin Berlin Campus Charité Mitte

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: Regional Anesthesia Touhy; The patients receive the planned anaesthesia procedure according to the procedure to be performed. Only nerve blockages are carried out, which are considered to be analgesic useful for the planned operations on the basis of typical nerve courses. A touhy cannula is used.
Active Comparator: 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.	Procedure: Regional Anesthesia Facet; The patients receive the planned anaesthesia procedure according to the procedure to be performed. Only nerve blockages are carried out, which are considered to be analgesic useful for the planned operations on the basis of typical nerve courses. A facet cannula is used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ultrasound distance	Ultrasound-based measurement of needle-nerve distance during the application of the regional anesthesia of the N. ischiadicus during infragluteal access.	duration of blockade, an average of 15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visibility_1	Ultrasound visibility of needle	duration of blockade, an average of 15 minutes
Visibility_2	Ultrasound visibility of nerve	duration of blockade, an average of 15 minutes
Impedance	Impedance measured by nerve stimulator while progressing the needle	duration of blockade, an average of 15 minutes
Effect_motor	Effectiveness of the motor blockade measured by possible movement of the foot	duration of surgery and recovery unit, an average of 120 minutes
Effect_sensoric	Effectiveness of the blockade measured by temperature sensibility testing on the food	duration of surgery and recovery unit, an average of 120 minutes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impedance_Change	Changes in impedance measurement while blockade	duration of blockade, an average of 15 minutes
Complications	Occurence of complications of regional anesthesia	duration of surgery and recovery unit, an average of 120 minutes
Contact	Number of Needle-Nerve-Contacts by Ultrasound-measurement	duration of blockade, an average of 15 minutes

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Principal Investigator: Jürgen Birnbaum, MD, PhD, Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2018
• Primary Completion (Actual): September 15, 2019
• Study Completion (Actual): September 15, 2019

Study Registration Dates

• First Submitted: December 14, 2017
• First Submitted That Met QC Criteria: December 19, 2017
• First Posted (Actual): December 26, 2017

Study Record Updates

• Last Update Posted (Actual): February 4, 2022
• Last Update Submitted That Met QC Criteria: January 21, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: DUAL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No