Dual Guidance in Regional Anesthesia

NCT ID: NCT03383770

Last Updated: 2022-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-05
• Study Completion Date: 2019-09-15

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.

Conditions

Anesthesia, Local; Anesthesia; Anesthesia; Adverse Effect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Regional Anesthesia Touhy

Intervention Type: PROCEDURE

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.

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.

Group Type: ACTIVE_COMPARATOR

Regional Anesthesia Facet

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Jurgen Birnbaum

PD Dr. med.; Consultant Anaesthesiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jürgen Birnbaum, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

Charité - Universitätsmedizin Berlin Campus Charité Mitte

Berlin, Deutschland, Germany

Countries

Germany

Other Identifiers

DUAL

Identifier Type: -

Identifier Source: org_study_id