Protective Nerve Stimulation in Regional Anesthesia

Suspended

• Conditions: Brachial Plexus Block; Nerve Block; Anesthesia, Local

• Registration Number: NCT03291691
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

Peripheral nerve blocks can be conducted with ultrasound, electrical nerve stimulation or landmark technique or a combination of this techniques. Whether a regional block should be conducted with a combination of those different possibilities is highly discussed. In this study the investigators want to show the effectiveness of new standard way of combined use of ultrasound and nerve stimulation, they call protective nerve stimulation. According to ethical vote we are conducting an observational study.

Detailed Description

All patients will get the regional block they need for the elective surgery. Before starting the block a standard monitoring will be established. After applying the monitoring the block will be performed by an experienced anesthetist in supervision of another experienced anesthetist. The nerve stimulator is set on a fixed current of 1.0 mA and a block without motoric response on this current is tried. Ultrasound images are saved. After performing the regional anesthesia the further anesthetic procedure will be carried out and the surgery will take place. After surgery the patients will be transported to the recovery room or Postanesthesia care unit.

Study Timeline

• Study First Submitted: 2017-07-25
• Study Start: 2017-09-20
• Study First Submitted QC: 2017-09-20
• Study First Posted: 2017-09-25
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-21
• Last Update Posted: 2022-02-04
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• written informed consent
• age of 18 or older
• elective surgery patients at Campus Charité Mitte with clinical benefit of regional anesthesia

Exclusion Criteria

• existing contraindication for regional nerve blocks or the use of Protective Nerve Stimulation
• patients who undergo outpatient treatment
• allergy against local anesthetics
• age under 18 years
• Lacking willingness to take part in the study
• ASA PS score of 4 or more
• preexisting neural damage in the effect area
• Diabetes mellitus, alcohol use disorder
• Participation in other prospective clinical interventional trials
• Accommodation in an institution due to an official or judicial order

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effectivity	Duration of preparation, surgery and recovery room (an average of 4 hours)	Effective motor blockade and sensitive blockade at fixed timepoints

Secondary Outcome Measures

Name	Time	Method
Satisfaction	Duration of preparation, surgery and recovery room (an average of 4 hours)	Satisfaction of the patient in a 6-step Likert scale
Muscle contractions	Duration of preparation, surgery and recovery room (an average of 4 hours)	Number of expected and unexpected muscle contractions
Paresthesia	Duration of preparation, surgery and recovery room (an average of 4 hours)	Number of expected and unexpected paresthesia
Pain after surgery	Duration of preparation, surgery and recovery room (an average of 4 hours)	Does the patient have pain after surgery? Pain during hospital stay will be measured with the Numeric Rating Scale (NRS-V). For patients unable of pain self-assessment (e.g. ventilated patients, patients in delirious state or patients with stroke affecting language skills) observer-rated pain scales will be applied: Behavioural Pain Scale (BPS for ventilated) and BPS-NI (for non-ventilated) patients.
Impedance	Duration of preparation, surgery and recovery room (an average of 4 hours)	impedance measured by the nerve stimulator while proceeding with the needle
Pain while blocking	Duration of preparation, surgery and recovery room (an average of 4 hours)	Does the patient have pain while blocking? Pain during hospital stay will be measured with the Numeric Rating Scale (NRS-V). For patients unable of pain self-assessment (e.g. ventilated patients, patients in delirious state or patients with stroke affecting language skills) observer-rated pain scales will be applied: Behavioural Pain Scale (BPS for ventilated) and BPS-NI (for non-ventilated) patients.
Changes of impedance	Duration of preparation, surgery and recovery room (an average of 4 hours)	changes of impedance measured by the nerve stimulator while proceeding with the needle

Trial Locations

Locations (1)

Charité - Universitätsmedizin Berlin Campus Charité Mitte; 🇩🇪 Berlin, Germany