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Anesthesia, LocalProNervNCT03291691

Protective Nerve Stimulation in Regional Anesthesia

An observational study of Anesthesia, Local and Nerve Block, run by Charite University, Berlin, Germany at 1 site in Germany.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
60 participants
Where
1 siteGermany
Study dates
20 Sep 2017to 31 Dec 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 60 female and male patients undergoing elective surgery with a regional block at Charité -Universitätsmedizin Berlin

Who may be able to join

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

Who cannot join

  • 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
Show all 10Show fewer
  • 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 locations and contacts

1 site in 1 country.

Germany1 site

  • Charité - Universitätsmedizin Berlin Campus Charité Mitte

    Berlin, 10117

Other trials in Germany

About this study

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

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.

Read the 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.

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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03291691
Study groupRoleWhat they receive
Standard of care: SCIPatients at Charite, with lower limb surgery undergoing a protective performed ultrasound guided sciatic nerve block. N=15.
Standard of care: FEMPatients at Charite, with lower limb surgery undergoing a protective performed ultrasound guided femoral nerve block. N=15.
Standard of care: ISBPatients at Charite, with upper limb surgery undergoing a protective performed ultrasound guided interscalene plexus block. N=15.
Standard of care: AXPPatients at Charite, with upper limb surgery undergoing a protective performed ultrasound guided axillary plexus block. N=15.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Effectivity

    Effective motor blockade and sensitive blockade at fixed timepoints

    Measured: Duration of preparation, surgery and recovery room (an average of 4 hours)

Secondary outcomes (7)

  1. Muscle contractions

    Number of expected and unexpected muscle contractions

    Measured: Duration of preparation, surgery and recovery room (an average of 4 hours)

  2. Paresthesia

    Number of expected and unexpected paresthesia

    Measured: Duration of preparation, surgery and recovery room (an average of 4 hours)

  3. Pain while blocking

    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.

    Measured: Duration of preparation, surgery and recovery room (an average of 4 hours)

  4. Pain after surgery

    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.

    Measured: Duration of preparation, surgery and recovery room (an average of 4 hours)

  5. Satisfaction

    Satisfaction of the patient in a 6-step Likert scale

    Measured: Duration of preparation, surgery and recovery room (an average of 4 hours)

  6. Impedance

    impedance measured by the nerve stimulator while proceeding with the needle

    Measured: Duration of preparation, surgery and recovery room (an average of 4 hours)

  7. Changes of impedance

    changes of impedance measured by the nerve stimulator while proceeding with the needle

    Measured: Duration of preparation, surgery and recovery room (an average of 4 hours)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2017
  2. Study start20 Sep 2017
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Why it stopped: for organizational reasons

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03291691
Sponsor's protocol ID
ProNerv
Acronym
ProNerv
Status last verified
Jan 2022
First submitted
25 Jul 2017
Last updated
4 Feb 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Salem MH, Winckelmann J, Geiger P, Mehrkens HH, Salem KH. Electrostimulation with or without ultrasound-guidance in interscalene brachial plexus block for shoulder surgery. J Anesth. 2012 Aug;26(4):610-3. doi: 10.1007/s00540-012-1366-x. Epub 2012 Mar 4.

    PubMed 22391670

  • Klaastad O, Sauter AR, Dodgson MS. Brachial plexus block with or without ultrasound guidance. Curr Opin Anaesthesiol. 2009 Oct;22(5):655-60. doi: 10.1097/ACO.0b013e32832eb7d3.

    PubMed 19550303

  • Dillane D, Tsui BC. Is there still a place for the use of nerve stimulation? Paediatr Anaesth. 2012 Jan;22(1):102-8. doi: 10.1111/j.1460-9592.2011.03729.x. Epub 2011 Nov 4.

    PubMed 22050512

  • Vassiliou T, Muller HH, Limberg S, De Andres J, Steinfeldt T, Wiesmann T. Risk evaluation for needle-nerve contact related to electrical nerve stimulation in a porcine model. Acta Anaesthesiol Scand. 2016 Mar;60(3):400-6. doi: 10.1111/aas.12664. Epub 2015 Dec 15.

    PubMed 26666693

  • Dexter F, Candiotti KA. Multicenter assessment of the Iowa Satisfaction with Anesthesia Scale, an instrument that measures patient satisfaction with monitored anesthesia care. Anesth Analg. 2011 Aug;113(2):364-8. doi: 10.1213/ANE.0b013e318217f804. Epub 2011 Apr 25.

    PubMed 21519043

  • Wiesmann T, Borntrager A, Vassiliou T, Hadzic A, Wulf H, Muller HH, Steinfeldt T. Minimal current intensity to elicit an evoked motor response cannot discern between needle-nerve contact and intraneural needle insertion. Anesth Analg. 2014 Mar;118(3):681-6. doi: 10.1213/ANE.0b013e3182a94454.

    PubMed 24284806

  • Wiesmann T, Steinfeldt T, Exner M, Nimphius W, De Andres J, Wulf H, Schwemmer U. Intraneural injection of a test dose of local anesthetic in peripheral nerves - does it induce histological changes in nerve tissue? Acta Anaesthesiol Scand. 2017 Jan;61(1):91-98. doi: 10.1111/aas.12825. Epub 2016 Oct 25.

    PubMed 27778324

  • Sen O, Sayilgan NC, Tutuncu AC, Bakan M, Koksal GM, Oz H. Evaluation of sciatic nerve damage following intraneural injection of bupivacaine, levobupivacaine and lidocaine in rats. Braz J Anesthesiol. 2016 May-Jun;66(3):272-5. doi: 10.1016/j.bjane.2014.09.012. Epub 2015 Mar 12.

    PubMed 27108824

  • Brull R, McCartney CJ, Chan VW, El-Beheiry H. Neurological complications after regional anesthesia: contemporary estimates of risk. Anesth Analg. 2007 Apr;104(4):965-74. doi: 10.1213/01.ane.0000258740.17193.ec.

    PubMed 17377115

Questions about this trial

What is this clinical trial studying?

An observational study of Anesthesia, Local and Nerve Block, run by Charite University, Berlin, Germany at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 4 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effectivity (time frame: Duration of preparation, surgery and recovery room (an average of 4 hours)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03291691, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2022.

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