Clinical trial NCT03383770: Dual Guidance in Regional Anesthesia
Official title: Dual Guidance in Regional Anesthesia - Prospective Randomized Study of Needle-nerve Distance in Different Cannulas for Regional Nerve Blockade
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, Local
Anesthesia
Anesthesia; Adverse Effect
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2017-12-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Ultrasound distance
timeFrame: duration of blockade, an average of 15 minutes
Secondary outcomes:
measure: Visibility_1
timeFrame: duration of blockade, an average of 15 minutes
measure: Visibility_2
timeFrame: duration of blockade, an average of 15 minutes
measure: Impedance
timeFrame: duration of blockade, an average of 15 minutes
measure: Effect_motor
timeFrame: duration of surgery and recovery unit, an average of 120 minutes
measure: Effect_sensoric
timeFrame: duration of surgery and recovery unit, an average of 120 minutes
Other outcomes:
measure: Impedance_Change
timeFrame: duration of blockade, an average of 15 minutes
measure: Complications
timeFrame: duration of surgery and recovery unit, an average of 120 minutes
measure: Contact
timeFrame: duration of blockade, an average of 15 minutes
Locations:
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin Campus Charité Mitte
state: Deutschland
Study officials:
affiliation: Charite University, Berlin, Germany
name: Jürgen Birnbaum, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: