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Protective Nerve Stimulation in Regional Anesthesia (ProNerv)

Charité University Medicine Berlin logo

Charité University Medicine Berlin

Status

Suspended

Conditions

Brachial Plexus Block
Anesthesia, Local
Nerve Block

Study type

Observational

Funder types

Other

Identifiers

NCT03291691
ProNerv

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

60 participants in 4 patient groups

Standard of care: SCI
Description:
Patients at Charite, with lower limb surgery undergoing a protective performed ultrasound guided sciatic nerve block. N=15.
Standard of care: FEM
Description:
Patients at Charite, with lower limb surgery undergoing a protective performed ultrasound guided femoral nerve block. N=15.
Standard of care: ISB
Description:
Patients at Charite, with upper limb surgery undergoing a protective performed ultrasound guided interscalene plexus block. N=15.
Standard of care: AXP
Description:
Patients at Charite, with upper limb surgery undergoing a protective performed ultrasound guided axillary plexus block. N=15.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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