Dual Guidance in Regional Anesthesia

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03383770
• Other study ID #: DUAL
• Status: Completed
• Phase: N/A
• Start date: February 5, 2018
• Est. completion date: September 15, 2019

Study information

• Verified date: January 2022
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 15, 2019
• Est. primary completion date: September 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Anesthesia, Local
• Anesthesia; Adverse Effect

Intervention

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.
• 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.

Locations

Country	Name	City	State
Germany	Charité - Universitätsmedizin Berlin Campus Charité Mitte	Berlin	Deutschland

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Impedance_Change	Changes in impedance measurement while blockade	duration of blockade, an average of 15 minutes
Other	Complications	Occurence of complications of regional anesthesia	duration of surgery and recovery unit, an average of 120 minutes
Other	Contact	Number of Needle-Nerve-Contacts by Ultrasound-measurement	duration of blockade, an average of 15 minutes
Primary	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	Visibility_1	Ultrasound visibility of needle	duration of blockade, an average of 15 minutes
Secondary	Visibility_2	Ultrasound visibility of nerve	duration of blockade, an average of 15 minutes
Secondary	Impedance	Impedance measured by nerve stimulator while progressing the needle	duration of blockade, an average of 15 minutes
Secondary	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
Secondary	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