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Clinical Trials/NCT03383770
NCT03383770
Completed
Not Applicable

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

Charite University, Berlin, Germany1 site in 1 country40 target enrollmentFebruary 5, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anesthesia, Local
Sponsor
Charite University, Berlin, Germany
Enrollment
40
Locations
1
Primary Endpoint
Ultrasound distance
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 5, 2018
End Date
September 15, 2019
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jurgen Birnbaum

PD Dr. med.; Consultant Anaesthesiologist

Charite University, Berlin, Germany

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)

Outcomes

Primary Outcomes

Ultrasound distance

Time Frame: 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 Outcomes

  • Visibility_1(duration of blockade, an average of 15 minutes)
  • Impedance(duration of blockade, an average of 15 minutes)
  • Visibility_2(duration of blockade, an average of 15 minutes)
  • Effect_sensoric(duration of surgery and recovery unit, an average of 120 minutes)
  • Effect_motor(duration of surgery and recovery unit, an average of 120 minutes)

Study Sites (1)

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