<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/NCT04451642</url>
  </required_header>
  <id_info>
    <org_study_id>POF-LEV-2019-01</org_study_id>
    <nct_id>NCT04451642</nct_id>
  </id_info>
  <brief_title>A Retrospective Clinical Registry of Peripheral Nerve Block</brief_title>
  <official_title>A Retrospective Clinical Registry of Peripheral Nerve Block: Current Practice and Complications</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto de Investigación Sanitaria Aragón</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital Miguel Servet</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Instituto de Investigación Sanitaria Aragón</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>
      Locorregional anaesthesia have been increased its role in different kind of surgeries, alone&#xD;
      or combined with general anesthesia. Due to ultrasound, peripheral nerve blocks have been&#xD;
      increased their importance in locoregional anaesthesia. They provide excellent intraoperative&#xD;
      and postoperative analgesia, decreasing the need for intravenous opioids which increase&#xD;
      postoperative nausea and vomiting which may prolong hospital stay.&#xD;
&#xD;
      The primary study objective is to analyze retrospectively the use of peripheral nerve blocks&#xD;
      in the current practice of a specialized regional anaesthesia division.&#xD;
&#xD;
      This is an observational, retrospective and unicenter study. 1346 patients scheduled for the&#xD;
      surgery needed a peripheral nerve block were enrolled.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Locorregional anaesthesia have been increased its role in different kind of surgeries, alone&#xD;
      or combined with general anesthesia. Due to ultrasound, peripheral nerve blocks have been&#xD;
      increased their importance in locoregional anaesthesia. They provide excellent intraoperative&#xD;
      and postoperative analgesia, decreasing the need for intravenous opioids which increase&#xD;
      postoperative nausea and vomiting which may prolong hospital stay.&#xD;
&#xD;
      However, peripheral nerve blocks may be associated with postoperative complications,&#xD;
      especially neurological ones. Classically, interscalene brachial plexus block produced a 100%&#xD;
      incidence of phrenic nerve paralysis with resultant pulmonary compromise. Little literature&#xD;
      has published a following of complications.&#xD;
&#xD;
      The primary study objective is to analyze retrospectively the use of peripheral nerve blocks&#xD;
      in the current practice of a specialized regional anaesthesia division. The secondary&#xD;
      objectives are assessed the patients characteristics of our sample, local anaesthetic dose&#xD;
      used, the peripheral nerve block operator, the nerve location technique, the surgery and the&#xD;
      complication rate after peripheral nerve block.&#xD;
&#xD;
      This is an observational, retrospective and unicenter study. 1346 patients scheduled for the&#xD;
      surgery needed a peripheral nerve block were enrolled.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2011</start_date>
  <completion_date type="Actual">November 30, 2019</completion_date>
  <primary_completion_date type="Actual">November 30, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Peripheral nerve block</measure>
    <time_frame>During procedure</time_frame>
    <description>This primary outcome is the type of peripheral nerve block performed</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence and frequency of Serious Adverse Events (SAE)</measure>
    <time_frame>From performing the peripheral nerve block to 1-year follow-up</time_frame>
    <description>This primary outcome is the incidence, frequency and severity of Serious Adverse Events (SAE) as assessed by CTCAE v4.0 after peripheral nerve block.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence and frequency of Postoperative neurological complications (PONC)</measure>
    <time_frame>From performing the peripheral nerve block to 1-year follow-up</time_frame>
    <description>This secondary outcome is the incidence, frequency and severity of Postoperative neurological complications (PONC) as assessed by CTCAE v4.0 after peripheral nerve block.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Local anesthetic used in peripheral nerve block</measure>
    <time_frame>During procedure</time_frame>
    <description>Local anesthetic type (FDA drug) used in peripheral nerve block performance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Local anesthetic dose used in peripheral nerve block</measure>
    <time_frame>During procedure</time_frame>
    <description>Local anesthetic dose (mg) used in peripheral nerve block performance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Local anesthetic volume used in peripheral nerve block</measure>
    <time_frame>During procedure</time_frame>
    <description>Local anesthetic volume (ml) used in peripheral nerve block performance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nerve location technique used in peripheral nerve block</measure>
    <time_frame>During procedure</time_frame>
    <description>Type of nerve location technique (ultrasound, nerve stimulator or paresthesia techinique) used in peripheral nerve block performance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peripheral nerve block operator</measure>
    <time_frame>During procedure</time_frame>
    <description>Anesthesiologist operator of peripheral nerve block (attending or trainee).</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">13816</enrollment>
  <condition>Nerve Block</condition>
  <condition>Regional Anesthesia</condition>
  <condition>Postoperative Complications</condition>
  <arm_group>
    <arm_group_label>Peripheral nerve block Group</arm_group_label>
    <description>Every patient scheduled during 2011-2019 for the surgery needed a peripheral nerve block were enrolled.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Peripheral nerve block</intervention_name>
    <description>Peripheral nerve block consists of the administration of a local anaesthetic into the nerves to inhibit nerve transmission in a specific part of the body. Ultrasound or Nerve stimulator could be used to locate the peripheral nerve. A needle is placed through the anatomical references to administer local anaesthetic around the peripheral nerve. Single-shot or continuous blocks are performed preoperatively and postoperatively as current practice in the surgery theatre. Using ultrasound, in-plane or out-plane approach could be performed. Peripheral nerve block provides excellent intraoperative and postoperative analgesia decreasing the need for intravenous pain drugs. Interscalene block, supraclavicular block, safene block, femoral block, BRILMA block are different kinds of peripheral nerve block using in the anaesthestic current practice.</description>
    <arm_group_label>Peripheral nerve block Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants were recruited from the current practice of the Anesthesia Department&#xD;
        (Division of Regional Anesthesia) at the Hospital Universitario Miguel Servet (HUMS) in&#xD;
        Zaragoza, Spain. HUMS provides health care to a population size of about 400000&#xD;
        inhabitants, mostly urban, and more than 200 shoulder and upper extremity surgeries are&#xD;
        performed every year.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Every patient who needs a peripheral nerve block performed by Anestesia Department.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient refusal of peripheral nerve block.&#xD;
&#xD;
          -  Known allergy to amide local anaesthetic drugs&#xD;
&#xD;
          -  Absolute contraindications to perform a peripheral nerve block as coagulopathy, active&#xD;
             infection at the block site or severe respiratory background.&#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>Pablo Oliver Forniés, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Miguel Servet</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Universitario Miguel Servet</name>
      <address>
        <city>Zaragoza</city>
        <zip>50012</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Toma O, Persoons B, Pogatzki-Zahn E, Van de Velde M, Joshi GP; PROSPECT Working Group collaborators. PROSPECT guideline for rotator cuff repair surgery: systematic review and procedure-specific postoperative pain management recommendations. Anaesthesia. 2019 Oct;74(10):1320-1331. doi: 10.1111/anae.14796. Epub 2019 Aug 7.</citation>
    <PMID>31392721</PMID>
  </reference>
  <reference>
    <citation>Singh A, Kelly C, O'Brien T, Wilson J, Warner JJ. Ultrasound-guided interscalene block anesthesia for shoulder arthroscopy: a prospective study of 1319 patients. J Bone Joint Surg Am. 2012 Nov 21;94(22):2040-6. doi: 10.2106/JBJS.K.01418.</citation>
    <PMID>23172321</PMID>
  </reference>
  <reference>
    <citation>Auroy Y, Benhamou D, Bargues L, Ecoffey C, Falissard B, Mercier FJ, Bouaziz H, Samii K. Major complications of regional anesthesia in France: The SOS Regional Anesthesia Hotline Service. Anesthesiology. 2002 Nov;97(5):1274-80. doi: 10.1097/00000542-200211000-00034. Erratum In: Anesthesiology. 2003 Feb;98(2):595. Mercier Frederic [corrected to Mercier Frederic J].</citation>
    <PMID>12411815</PMID>
  </reference>
  <reference>
    <citation>Bomberg H, Wetjen L, Wagenpfeil S, Schope J, Kessler P, Wulf H, Wiesmann T, Standl T, Gottschalk A, Doffert J, Hering W, Birnbaum J, Kutter B, Winckelmann J, Liebl-Biereige S, Meissner W, Vicent O, Koch T, Burkle H, Sessler DI, Volk T. Risks and Benefits of Ultrasound, Nerve Stimulation, and Their Combination for Guiding Peripheral Nerve Blocks: A Retrospective Registry Analysis. Anesth Analg. 2018 Oct;127(4):1035-1043. doi: 10.1213/ANE.0000000000003480.</citation>
    <PMID>29863605</PMID>
  </reference>
  <reference>
    <citation>Fredrickson MJ, Kilfoyle DH. Neurological complication analysis of 1000 ultrasound guided peripheral nerve blocks for elective orthopaedic surgery: a prospective study. Anaesthesia. 2009 Aug;64(8):836-44. doi: 10.1111/j.1365-2044.2009.05938.x.</citation>
    <PMID>19604186</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>August 8, 2022</last_update_submitted>
  <last_update_submitted_qc>August 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Regional Anesthesia</keyword>
  <keyword>Postoperative neurological complications</keyword>
  <keyword>Ultrasound</keyword>
  <keyword>Nerve stimulator</keyword>
  <keyword>Brachial Plexus Block</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Postoperative Complications</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All collected IPD will be available on file in storage and on the Internet (URL undecided yet) after finishing the data collection for 25 years at the participating site.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Starting in July 2021 for 25 years. DOI: 10.1007/s00540-021-02989-7</ipd_time_frame>
    <ipd_access_criteria>To contact to Study Principal Investigator.&#xD;
To provide to Study Principal Investigator a request to explain the reason to access to IPD study.</ipd_access_criteria>
    <ipd_url>https://click.endnote.com/viewer?doi=10.1007%2Fs00540-021-02989-7&amp;token=WzMwOTc0MjEsIjEwLjEwMDcvczAwNTQwLTAyMS0wMjk4OS03Il0.Mx20LMo0vR9ZI0CnH8cJ4g7lBD8</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 20, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/42/NCT04451642/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 20, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/42/NCT04451642/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04451642
org study id: POF-LEV-2019-01
nct id: NCT04451642
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Locorregional anaesthesia have been increased its role in different kind of surgeries, alone
      or combined with general anesthesia. Due to ultrasound, peripheral nerve blocks have been
      increased their importance in locoregional anaesthesia. They provide excellent intraoperative
      and postoperative analgesia, decreasing the need for intravenous opioids which increase
      postoperative nausea and vomiting which may prolong hospital stay.

      The primary study objective is to analyze retrospectively the use of peripheral nerve blocks
      in the current practice of a specialized regional anaesthesia division.

      This is an observational, retrospective and unicenter study. 1346 patients scheduled for the
      surgery needed a peripheral nerve block were enrolled.
Locorregional anaesthesia have been increased its role in different kind of surgeries, alone
      or combined with general anesthesia. Due to ultrasound, peripheral nerve blocks have been
      increased their importance in locoregional anaesthesia. They provide excellent intraoperative
      and postoperative analgesia, decreasing the need for intravenous opioids which increase
      postoperative nausea and vomiting which may prolong hospital stay.

      However, peripheral nerve blocks may be associated with postoperative complications,
      especially neurological ones. Classically, interscalene brachial plexus block produced a 100%
      incidence of phrenic nerve paralysis with resultant pulmonary compromise. Little literature
      has published a following of complications.

      The primary study objective is to analyze retrospectively the use of peripheral nerve blocks
      in the current practice of a specialized regional anaesthesia division. The secondary
      objectives are assessed the patients characteristics of our sample, local anaesthetic dose
      used, the peripheral nerve block operator, the nerve location technique, the surgery and the
      complication rate after peripheral nerve block.

      This is an observational, retrospective and unicenter study. 1346 patients scheduled for the
      surgery needed a peripheral nerve block were enrolled.
observational model: Case-Only
time perspective: Retrospective
measure: Peripheral nerve block
time frame: During procedure
description: This primary outcome is the type of peripheral nerve block performed
measure: Incidence and frequency of Serious Adverse Events (SAE)
time frame: From performing the peripheral nerve block to 1-year follow-up
description: This primary outcome is the incidence, frequency and severity of Serious Adverse Events (SAE) as assessed by CTCAE v4.0 after peripheral nerve block.
measure: Incidence and frequency of Postoperative neurological complications (PONC)
time frame: From performing the peripheral nerve block to 1-year follow-up
description: This secondary outcome is the incidence, frequency and severity of Postoperative neurological complications (PONC) as assessed by CTCAE v4.0 after peripheral nerve block.
measure: Local anesthetic used in peripheral nerve block
time frame: During procedure
description: Local anesthetic type (FDA drug) used in peripheral nerve block performance
measure: Local anesthetic dose used in peripheral nerve block
time frame: During procedure
description: Local anesthetic dose (mg) used in peripheral nerve block performance
measure: Local anesthetic volume used in peripheral nerve block
time frame: During procedure
description: Local anesthetic volume (ml) used in peripheral nerve block performance
measure: Nerve location technique used in peripheral nerve block
time frame: During procedure
description: Type of nerve location technique (ultrasound, nerve stimulator or paresthesia techinique) used in peripheral nerve block performance
measure: Peripheral nerve block operator
time frame: During procedure
description: Anesthesiologist operator of peripheral nerve block (attending or trainee).
arm group label: Peripheral nerve block Group
description: Every patient scheduled during 2011-2019 for the surgery needed a peripheral nerve block were enrolled.
intervention type: Procedure
intervention name: Peripheral nerve block
description: Peripheral nerve block consists of the administration of a local anaesthetic into the nerves to inhibit nerve transmission in a specific part of the body. Ultrasound or Nerve stimulator could be used to locate the peripheral nerve. A needle is placed through the anatomical references to administer local anaesthetic around the peripheral nerve. Single-shot or continuous blocks are performed preoperatively and postoperatively as current practice in the surgery theatre. Using ultrasound, in-plane or out-plane approach could be performed. Peripheral nerve block provides excellent intraoperative and postoperative analgesia decreasing the need for intravenous pain drugs. Interscalene block, supraclavicular block, safene block, femoral block, BRILMA block are different kinds of peripheral nerve block using in the anaesthestic current practice.
arm group label: Peripheral nerve block Group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pablo Oliver Forniés, MD
role: Principal Investigator
affiliation: Hospital Miguel Servet
facility: 
country: Spain
citation: Toma O, Persoons B, Pogatzki-Zahn E, Van de Velde M, Joshi GP; PROSPECT Working Group collaborators. PROSPECT guideline for rotator cuff repair surgery: systematic review and procedure-specific postoperative pain management recommendations. Anaesthesia. 2019 Oct;74(10):1320-1331. doi: 10.1111/anae.14796. Epub 2019 Aug 7.
PMID: 31392721
citation: Singh A, Kelly C, O'Brien T, Wilson J, Warner JJ. Ultrasound-guided interscalene block anesthesia for shoulder arthroscopy: a prospective study of 1319 patients. J Bone Joint Surg Am. 2012 Nov 21;94(22):2040-6. doi: 10.2106/JBJS.K.01418.
PMID: 23172321
citation: Auroy Y, Benhamou D, Bargues L, Ecoffey C, Falissard B, Mercier FJ, Bouaziz H, Samii K. Major complications of regional anesthesia in France: The SOS Regional Anesthesia Hotline Service. Anesthesiology. 2002 Nov;97(5):1274-80. doi: 10.1097/00000542-200211000-00034. Erratum In: Anesthesiology. 2003 Feb;98(2):595. Mercier Frederic [corrected to Mercier Frederic J].
PMID: 12411815
citation: Bomberg H, Wetjen L, Wagenpfeil S, Schope J, Kessler P, Wulf H, Wiesmann T, Standl T, Gottschalk A, Doffert J, Hering W, Birnbaum J, Kutter B, Winckelmann J, Liebl-Biereige S, Meissner W, Vicent O, Koch T, Burkle H, Sessler DI, Volk T. Risks and Benefits of Ultrasound, Nerve Stimulation, and Their Combination for Guiding Peripheral Nerve Blocks: A Retrospective Registry Analysis. Anesth Analg. 2018 Oct;127(4):1035-1043. doi: 10.1213/ANE.0000000000003480.
PMID: 29863605
citation: Fredrickson MJ, Kilfoyle DH. Neurological complication analysis of 1000 ultrasound guided peripheral nerve blocks for elective orthopaedic surgery: a prospective study. Anaesthesia. 2009 Aug;64(8):836-44. doi: 10.1111/j.1365-2044.2009.05938.x.
PMID: 19604186
responsible party type: Sponsor
mesh term: Postoperative Complications
sharing ipd: Yes
ipd description: All collected IPD will be available on file in storage and on the Internet (URL undecided yet) after finishing the data collection for 25 years at the participating site.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Starting in July 2021 for 25 years. DOI: 10.1007/s00540-021-02989-7
ipd access criteria: To contact to Study Principal Investigator.
To provide to Study Principal Investigator a request to explain the reason to access to IPD study.
ipd url: https://click.endnote.com/viewer?doi=10.1007%2Fs00540-021-02989-7&token=WzMwOTc0MjEsIjEwLjEwMDcvczAwNTQwLTAyMS0wMjk4OS03Il0.Mx20LMo0vR9ZI0CnH8cJ4g7lBD8
provided document: 
provided document: 