<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03291691</url>
  </required_header>
  <id_info>
    <org_study_id>ProNerv</org_study_id>
    <nct_id>NCT03291691</nct_id>
  </id_info>
  <brief_title>Protective Nerve Stimulation in Regional Anesthesia</brief_title>
  <acronym>ProNerv</acronym>
  <official_title>The Use of Protective Nerve Stimulation in Different Regional Anesthetic Blocks (Interscalene, Axillary, Femoral and Sciatic Nerve Blocks)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Charite University, Berlin, Germany</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Charite University, Berlin, Germany</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Peripheral nerve blocks can be conducted with ultrasound, electrical nerve stimulation or&#xD;
      landmark technique or a combination of this techniques. Whether a regional block should be&#xD;
      conducted with a combination of those different possibilities is highly discussed. In this&#xD;
      study the investigators want to show the effectiveness of new standard way of combined use of&#xD;
      ultrasound and nerve stimulation, they call protective nerve stimulation. According to&#xD;
      ethical vote we are conducting an observational study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All patients will get the regional block they need for the elective surgery. Before starting&#xD;
      the block a standard monitoring will be established. After applying the monitoring the block&#xD;
      will be performed by an experienced anesthetist in supervision of another experienced&#xD;
      anesthetist. The nerve stimulator is set on a fixed current of 1.0 mA and a block without&#xD;
      motoric response on this current is tried. Ultrasound images are saved. After performing the&#xD;
      regional anesthesia the further anesthetic procedure will be carried out and the surgery will&#xD;
      take place. After surgery the patients will be transported to the recovery room or&#xD;
      Postanesthesia care unit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    for organizational reasons&#xD;
  </why_stopped>
  <start_date type="Actual">September 20, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Effectivity</measure>
    <time_frame>Duration of preparation, surgery and recovery room (an average of 4 hours)</time_frame>
    <description>Effective motor blockade and sensitive blockade at fixed timepoints</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Muscle contractions</measure>
    <time_frame>Duration of preparation, surgery and recovery room (an average of 4 hours)</time_frame>
    <description>Number of expected and unexpected muscle contractions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Paresthesia</measure>
    <time_frame>Duration of preparation, surgery and recovery room (an average of 4 hours)</time_frame>
    <description>Number of expected and unexpected paresthesia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain while blocking</measure>
    <time_frame>Duration of preparation, surgery and recovery room (an average of 4 hours)</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain after surgery</measure>
    <time_frame>Duration of preparation, surgery and recovery room (an average of 4 hours)</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction</measure>
    <time_frame>Duration of preparation, surgery and recovery room (an average of 4 hours)</time_frame>
    <description>Satisfaction of the patient in a 6-step Likert scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impedance</measure>
    <time_frame>Duration of preparation, surgery and recovery room (an average of 4 hours)</time_frame>
    <description>impedance measured by the nerve stimulator while proceeding with the needle</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of impedance</measure>
    <time_frame>Duration of preparation, surgery and recovery room (an average of 4 hours)</time_frame>
    <description>changes of impedance measured by the nerve stimulator while proceeding with the needle</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Bloody Tap</measure>
    <time_frame>Duration of preparation, surgery and recovery room (an average of 4 hours)</time_frame>
    <description>Appearance of Bloody Tap before, during and after the block (yes/no)</description>
  </other_outcome>
  <other_outcome>
    <measure>Postoperative Nausea and Vomiting</measure>
    <time_frame>Duration of preparation, surgery and recovery room (an average of 4 hours)</time_frame>
    <description>Appearance of PONV before, during and after the block (yes/no)</description>
  </other_outcome>
  <other_outcome>
    <measure>pruritus</measure>
    <time_frame>Duration of preparation, surgery and recovery room (an average of 4 hours)</time_frame>
    <description>Appearance of pruritus before, during and after the block (yes/no)</description>
  </other_outcome>
  <other_outcome>
    <measure>Analgetics consumption</measure>
    <time_frame>Duration of preparation, surgery and recovery room (an average of 4 hours)</time_frame>
    <description>Amount of opioids needed before, during and after the surgery until the patient leaves the recovery unit</description>
  </other_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Anesthesia, Local</condition>
  <condition>Nerve Block</condition>
  <condition>Brachial Plexus Block</condition>
  <arm_group>
    <arm_group_label>Standard of care: SCI</arm_group_label>
    <description>Patients at Charite, with lower limb surgery undergoing a protective performed ultrasound guided sciatic nerve block. N=15.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of care: FEM</arm_group_label>
    <description>Patients at Charite, with lower limb surgery undergoing a protective performed ultrasound guided femoral nerve block. N=15.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of care: ISB</arm_group_label>
    <description>Patients at Charite, with upper limb surgery undergoing a protective performed ultrasound guided interscalene plexus block. N=15.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of care: AXP</arm_group_label>
    <description>Patients at Charite, with upper limb surgery undergoing a protective performed ultrasound guided axillary plexus block. N=15.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        60 female and male patients undergoing elective surgery with a regional block at Charité&#xD;
        -Universitätsmedizin Berlin&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
          -  age of 18 or older&#xD;
&#xD;
          -  elective surgery patients at Campus Charité Mitte with clinical benefit of regional&#xD;
             anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  existing contraindication for regional nerve blocks or the use of Protective Nerve&#xD;
             Stimulation&#xD;
&#xD;
          -  patients who undergo outpatient treatment&#xD;
&#xD;
          -  allergy against local anesthetics&#xD;
&#xD;
          -  age under 18 years&#xD;
&#xD;
          -  Lacking willingness to take part in the study&#xD;
&#xD;
          -  ASA PS score of 4 or more&#xD;
&#xD;
          -  preexisting neural damage in the effect area&#xD;
&#xD;
          -  Diabetes mellitus, alcohol use disorder&#xD;
&#xD;
          -  Participation in other prospective clinical interventional trials&#xD;
&#xD;
          -  Accommodation in an institution due to an official or judicial order&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jürgen Birnbaum, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Charite University, Berlin, Germany</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Charité - Universitätsmedizin Berlin Campus Charité Mitte</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>22391670</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>19550303</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>22050512</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>26666693</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>21519043</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>24284806</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>27778324</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>27108824</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>17377115</PMID>
  </reference>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>January 21, 2022</last_update_submitted>
  <last_update_submitted_qc>January 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Charite University, Berlin, Germany</investigator_affiliation>
    <investigator_full_name>Jurgen Birnbaum</investigator_full_name>
    <investigator_title>Principal Investigator and Consultant of the Department of Anesthesiology and Operative Intensive Care Medicine, CCM and CVK</investigator_title>
  </responsible_party>
  <keyword>Protective Nerve Stimulation</keyword>
  <keyword>Regional Anesthesia</keyword>
  <keyword>Sciatic nerve block</keyword>
  <keyword>femoral nerve block</keyword>
  <keyword>brachial plexus block</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03291691
org study id: ProNerv
nct id: NCT03291691
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Effectivity
time frame: Duration of preparation, surgery and recovery room (an average of 4 hours)
description: Effective motor blockade and sensitive blockade at fixed timepoints
measure: Muscle contractions
time frame: Duration of preparation, surgery and recovery room (an average of 4 hours)
description: Number of expected and unexpected muscle contractions
measure: Paresthesia
time frame: Duration of preparation, surgery and recovery room (an average of 4 hours)
description: Number of expected and unexpected paresthesia
measure: Pain while blocking
time frame: Duration of preparation, surgery and recovery room (an average of 4 hours)
description: 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.
measure: Pain after surgery
time frame: Duration of preparation, surgery and recovery room (an average of 4 hours)
description: 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.
measure: Satisfaction
time frame: Duration of preparation, surgery and recovery room (an average of 4 hours)
description: Satisfaction of the patient in a 6-step Likert scale
measure: Impedance
time frame: Duration of preparation, surgery and recovery room (an average of 4 hours)
description: impedance measured by the nerve stimulator while proceeding with the needle
measure: Changes of impedance
time frame: Duration of preparation, surgery and recovery room (an average of 4 hours)
description: changes of impedance measured by the nerve stimulator while proceeding with the needle
measure: Bloody Tap
time frame: Duration of preparation, surgery and recovery room (an average of 4 hours)
description: Appearance of Bloody Tap before, during and after the block (yes/no)
measure: Postoperative Nausea and Vomiting
time frame: Duration of preparation, surgery and recovery room (an average of 4 hours)
description: Appearance of PONV before, during and after the block (yes/no)
measure: pruritus
time frame: Duration of preparation, surgery and recovery room (an average of 4 hours)
description: Appearance of pruritus before, during and after the block (yes/no)
measure: Analgetics consumption
time frame: Duration of preparation, surgery and recovery room (an average of 4 hours)
description: Amount of opioids needed before, during and after the surgery until the patient leaves the recovery unit
arm group label: Standard of care: SCI
description: Patients at Charite, with lower limb surgery undergoing a protective performed ultrasound guided sciatic nerve block. N=15.
arm group label: Standard of care: FEM
description: Patients at Charite, with lower limb surgery undergoing a protective performed ultrasound guided femoral nerve block. N=15.
arm group label: Standard of care: ISB
description: Patients at Charite, with upper limb surgery undergoing a protective performed ultrasound guided interscalene plexus block. N=15.
arm group label: Standard of care: AXP
description: Patients at Charite, with upper limb surgery undergoing a protective performed ultrasound guided axillary plexus block. N=15.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jürgen Birnbaum, MD
role: Principal Investigator
affiliation: Charite University, Berlin, Germany
facility: 
country: Germany
citation: 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.
PMID: 22391670
citation: 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.
PMID: 19550303
citation: 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.
PMID: 22050512
citation: 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.
PMID: 26666693
citation: 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.
PMID: 21519043
citation: 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.
PMID: 24284806
citation: 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.
PMID: 27778324
citation: 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.
PMID: 27108824
citation: 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.
PMID: 17377115
responsible party type: Principal Investigator
investigator affiliation: Charite University, Berlin, Germany
investigator full name: Jurgen Birnbaum
investigator title: Principal Investigator and Consultant of the Department of Anesthesiology and Operative Intensive Care Medicine, CCM and CVK
sharing ipd: No