NCT03383770

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 26, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

February 5, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2019

Completed
Last Updated

February 4, 2022

Status Verified

January 1, 2022

Enrollment Period

1.6 years

First QC Date

December 14, 2017

Last Update Submit

January 21, 2022

Conditions

Anesthesia, LocalAnesthesiaAnesthesia; Adverse Effect

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Visibility_1

    duration of blockade, an average of 15 minutes

  • Visibility_2

    duration of blockade, an average of 15 minutes

  • Impedance

    duration of blockade, an average of 15 minutes

  • Effect_motor

    duration of surgery and recovery unit, an average of 120 minutes

  • Effect_sensoric

    duration of surgery and recovery unit, an average of 120 minutes

Other Outcomes (3)

  • Impedance_Change

    duration of blockade, an average of 15 minutes

  • Complications

    duration of surgery and recovery unit, an average of 120 minutes

  • Contact

    duration of blockade, an average of 15 minutes

Study Arms (2)

Tuohy

ACTIVE COMPARATOR

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

Facet

ACTIVE COMPARATOR

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

Interventions

Regional Anesthesia TouhyPROCEDURE

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.

Tuohy
Regional Anesthesia FacetPROCEDURE

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.

Facet

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Presence of the written declaration of consent
  • Age of at least 18 years
  • No participation in another intervention study during participation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité - Universitätsmedizin Berlin Campus Charité Mitte

Berlin, Deutschland, 10115, Germany

Location

Study Officials

  • Jürgen Birnbaum, MD, PhD

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The selection of the puncture cannula for regional anaesthesia is not up to the performing anaesthetist, as is usual in the clinical standard, but is made randomly on the basis of a random list. The blockade is carried out by two anaesthetists experienced in regional anaesthesia, who have the principle of dual control. The ultrasound image acquired during the blockade is recorded in the form of an ultrasound video for subsequent evaluation. The recorded ultrasound videos are stored pseudonymously on the server of the Klinik für Anästhesiologie m. S. operativ Intensivmedizin reported to the data protection department.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr. med.; Consultant Anaesthesiologist

Study Record Dates

First Submitted

December 14, 2017

First Posted

December 26, 2017

Study Start

February 5, 2018

Primary Completion

September 15, 2019

Study Completion

September 15, 2019

Last Updated

February 4, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)