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Protective Nerve Stimulation in Regional Anesthesia

The Use of Protective Nerve Stimulation in Different Regional Anesthetic Blocks (Interscalene, Axillary, Femoral and Sciatic Nerve Blocks)

Status
Suspended
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03291691
Acronym
ProNerv
Enrollment
60
Registered
2017-09-25
Start date
2017-09-20
Completion date
2023-12-31
Last updated
2022-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Local, Brachial Plexus Block, Nerve Block

Keywords

Protective Nerve Stimulation, Regional Anesthesia, Sciatic nerve block, femoral nerve block, brachial plexus block

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.

Interventions

None listed

Sponsors

Charite University, Berlin, Germany
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
EffectivityDuration of preparation, surgery and recovery room (an average of 4 hours)Effective motor blockade and sensitive blockade at fixed timepoints

Secondary

MeasureTime frameDescription
Pain while blockingDuration 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.
Pain after surgeryDuration 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.
SatisfactionDuration of preparation, surgery and recovery room (an average of 4 hours)Satisfaction of the patient in a 6-step Likert scale
ImpedanceDuration of preparation, surgery and recovery room (an average of 4 hours)impedance measured by the nerve stimulator while proceeding with the needle
Changes of impedanceDuration of preparation, surgery and recovery room (an average of 4 hours)changes of impedance measured by the nerve stimulator while proceeding with the needle
Muscle contractionsDuration of preparation, surgery and recovery room (an average of 4 hours)Number of expected and unexpected muscle contractions
ParesthesiaDuration of preparation, surgery and recovery room (an average of 4 hours)Number of expected and unexpected paresthesia

Other

MeasureTime frameDescription
pruritusDuration of preparation, surgery and recovery room (an average of 4 hours)Appearance of pruritus before, during and after the block (yes/no)
Analgetics consumptionDuration of preparation, surgery and recovery room (an average of 4 hours)Amount of opioids needed before, during and after the surgery until the patient leaves the recovery unit
Bloody TapDuration of preparation, surgery and recovery room (an average of 4 hours)Appearance of Bloody Tap before, during and after the block (yes/no)
Postoperative Nausea and VomitingDuration of preparation, surgery and recovery room (an average of 4 hours)Appearance of PONV before, during and after the block (yes/no)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026