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Completed

NCT Number: NCT03383770

Dual Guidance in Regional Anesthesia

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.

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Key information

Conditions

Anesthesia, Local Anesthesia Anesthesia; Adverse Effect

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charité - Universitätsmedizin Berlin Campus Charité Mitte

Berlin, Deutschland, 10115, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Regional Anesthesia Touhy

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.

Regional Anesthesia Facet

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.

Primary outcomes

  1. 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

  1. Visibility_1

    Time frame: duration of blockade, an average of 15 minutes

    Ultrasound visibility of needle

  2. Visibility_2

    Time frame: duration of blockade, an average of 15 minutes

    Ultrasound visibility of nerve

  3. Impedance

    Time frame: duration of blockade, an average of 15 minutes

    Impedance measured by nerve stimulator while progressing the needle

  4. Effect_motor

    Time frame: duration of surgery and recovery unit, an average of 120 minutes

    Effectiveness of the motor blockade measured by possible movement of the foot

  5. Effect_sensoric

    Time frame: duration of surgery and recovery unit, an average of 120 minutes

    Effectiveness of the blockade measured by temperature sensibility testing on the food

Other outcomes

  1. Impedance_Change

    Time frame: duration of blockade, an average of 15 minutes

    Changes in impedance measurement while blockade

  2. Complications

    Time frame: duration of surgery and recovery unit, an average of 120 minutes

    Occurence of complications of regional anesthesia

  3. Contact

    Time frame: duration of blockade, an average of 15 minutes

    Number of Needle-Nerve-Contacts by Ultrasound-measurement

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 26, 2017
Registry last updated
Feb 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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