<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/NCT03758261</url>
  </required_header>
  <id_info>
    <org_study_id>PRO18070064</org_study_id>
    <nct_id>NCT03758261</nct_id>
  </id_info>
  <brief_title>Erector Spinae Plane vs. Paravertebral Nerve Block for Thoracic Surgery</brief_title>
  <official_title>Randomized Clinical Trial of Erector Spinae Plane (ESP) Versus Paravertebral Nerve (PVB) Blockade for Video Assisted Thoracoscopic Surgery (VATS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Charles Luke</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pittsburgh</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Continuous paravertebral analgesia and erector spinae plane blockade (ESP) are accepted&#xD;
      techniques at University of Pittsburgh Medical Center (UPMC) for the management of thoracic&#xD;
      pain following surgery and trauma. Recently, an increasing number of erector spinae plane&#xD;
      nerve blocks are being performed as it has been demonstrated in our institution, and via case&#xD;
      reports that the blocks provide clinical effectiveness, but may have a better side-effect&#xD;
      profile than the paravertebral nerve block. However, the relative efficacy of ESP compared to&#xD;
      paravertebral nerve block remains to be established for video assisted thoracoscopic surgery&#xD;
      (VATS). This is a prospective randomized study intended to assess the efficacy, safety and&#xD;
      side-effect profile of continuous erector spinae plane analgesia versus continuous&#xD;
      paravertebral analgesia for VATS procedures. It will include 60 patients presenting to UPMC&#xD;
      Passavant for a VATS procedure. Patients will be randomized 1:1 to receive either a nerve&#xD;
      block via continuous paravertebral infusion or via erector spinae plane infusion. In&#xD;
      addition, to treat breakthrough pain, the patients in both arms will receive multimodal&#xD;
      adjunctive therapy per routine. Bupivacaine and ropivacaine are FDA approved for use in nerve&#xD;
      block catheters. The primary outcome will be to compare analgesic efficacy between the two&#xD;
      nerve blocks as defined by total opioid consumption and pain scores on the numeric pain&#xD;
      rating scale. Secondary outcomes include incentive spirometer amounts (baseline vs daily&#xD;
      score postoperatively), length of stay, duration of catheter and report of adverse events or&#xD;
      complications. Other data points include number of chest tubes and location and level of&#xD;
      catheter and nerve block placement as well as number of blocks per case.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background and significance:&#xD;
&#xD;
      Multimodal analgesia for thoracic surgery is key to allow faster recovery and diminish&#xD;
      postoperative complications. Paravertebral nerve blocks as well as epidurals are among the&#xD;
      regional anesthetic techniques utilized for these procedures. Recently, a newer technique,&#xD;
      the erector spinae plane block, has been used and described to be effective in treating pain&#xD;
      for patients undergoing thoracic surgery. At UPMC, the investigators have had clinically&#xD;
      significant pain control for thoracic surgery with both types of blocks. The previous case&#xD;
      reports/series and our clinical observation has led us to propose this study of comparing the&#xD;
      clinical efficacy of erector spinae plane block vs. paravertebral nerve block.&#xD;
&#xD;
      Though ESP and paravertebral blocks have been documented to be efficacious for this&#xD;
      procedure, there has been no direct comparison between the two approaches. The ESP block is&#xD;
      considered to be a safer technique with less theoretical adverse events possible and thus,&#xD;
      would become a viable alternative to the more technically challenging paravertebral nerve&#xD;
      block. If ESP is found to be superior or non-inferior to paravertebral in terms of pain&#xD;
      management and safety, this would be a major finding, as ESP is considered safer and&#xD;
      technically easier to perform than paravertebral nerve block.&#xD;
&#xD;
      Study design and methods&#xD;
&#xD;
      The investigators present a prospective randomized trial comparing the efficacy of continuous&#xD;
      paravertebral nerve blocks vs. ESP blocks for video assisted thoracoscopy surgery (VATS) at&#xD;
      UPMC Passavant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 11, 2019</start_date>
  <completion_date type="Actual">June 25, 2020</completion_date>
  <primary_completion_date type="Actual">June 12, 2020</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>2 groups of patients will be studied simultaneously. One group will have the intervention of the nerve block in the erector spinae approach and the other group will have the nerve block in the traditional paravertebral approach.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total Opioid Consumption</measure>
    <time_frame>1 day post catheter removal</time_frame>
    <description>Morphine equivalents (total OME)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Reported Pain Scores</measure>
    <time_frame>1 day post catheter removal</time_frame>
    <description>Visual analog scale. Scale is from 0 to 10 numerical pain rating scale. 0 indicates no pain. 10 indicates maximum level of pain. Higher scores indicate worse pain level. Pain score will be a single number from 0 to 10.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Amount Achieved on Incentive Spirometer</measure>
    <time_frame>1 day post catheter removal</time_frame>
    <description>Amount achieved on incentive spirometer device (mL). Higher level indicates better respiratory effort</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of Hospital Stay</measure>
    <time_frame>Up to 2 weeks on average</time_frame>
    <description>Length of hospital stay post-surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time Catheter Remains Inserted in Body</measure>
    <time_frame>6 days</time_frame>
    <description>How long catheter remains providing pain relief</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Averaged Total of Narcotic Usage</measure>
    <time_frame>0-120 hours post-operative</time_frame>
    <description>Averaged total Narcotic consumption measured in Oral Morphine Equivalence (OME)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Report of Adverse Events From Catheter Placement</measure>
    <time_frame>1 day post catheter removal</time_frame>
    <description>Participant count for patients who experienced adverse events with nerve block catheter placement which includes pneumothorax, infections, bleeding, local anesthetic toxicity.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Thoracic Surgical Procedures</condition>
  <arm_group>
    <arm_group_label>Erector Spinae Nerve Block</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Erector Spinae nerve block</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Paravertebral Nerve Block</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Paravertebral nerve block</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paravertebral nerve block</intervention_name>
    <description>The patient will be placed in a sitting position and the level of needle insertion will be marked corresponding to the level of surgical incision. With sterile technique an ultrasound Paravertebral Nerve Block will be performed.</description>
    <arm_group_label>Paravertebral Nerve Block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Erector Spinae nerve block</intervention_name>
    <description>The patient will be placed in a sitting position and the level of needle insertion will be marked corresponding to the level of surgical incision. With sterile technique an ultrasound erector spinae nerve block will be performed.</description>
    <arm_group_label>Erector Spinae Nerve Block</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Patients undergoing VATS agreeable to have a nerve block as analgesic technique&#xD;
&#xD;
          -  Age: 18 years old and older.&#xD;
&#xD;
          -  ASA (American Society of Anesthesiologists Class) I-IV&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Cognitive impairment that would not allow effective nerve block placement or gathering&#xD;
             information related to the study (ex. pain score).&#xD;
&#xD;
          -  Contraindications for nerve block placement such as coagulopathy, use of clopidogrel&#xD;
             in the past 48hs, patients on dual antiplatelet therapy, infection at the site of&#xD;
             puncture, patient refusal, allergy to local anesthetics.&#xD;
&#xD;
          -  Chronic opiate consumption&#xD;
&#xD;
          -  Patient expected to be on therapeutic anticoagulation post procedure.&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Comorbid conditions: Any comorbid condition that in the judgment of the&#xD;
             anesthesiologist would preclude the patient from any aspect of the study (ex. sepsis,&#xD;
             possibly abnormalities of the thoracic spine or paravertebral anatomy such as&#xD;
             neoplastic mass occupying the space, empyema, increased intracranial pressure)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Charles Luke, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UPMC Passavant</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15237</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>D'Ercole F, Arora H, Kumar PA. Paravertebral Block for Thoracic Surgery. J Cardiothorac Vasc Anesth. 2018 Apr;32(2):915-927. doi: 10.1053/j.jvca.2017.10.003. Epub 2017 Oct 4.</citation>
    <PMID>29169795</PMID>
  </reference>
  <reference>
    <citation>Yeung JH, Gates S, Naidu BV, Wilson MJ, Gao Smith F. Paravertebral block versus thoracic epidural for patients undergoing thoracotomy. Cochrane Database Syst Rev. 2016 Feb 21;2(2):CD009121. doi: 10.1002/14651858.CD009121.pub2.</citation>
    <PMID>26897642</PMID>
  </reference>
  <reference>
    <citation>Tsui BCH, Fonseca A, Munshey F, McFadyen G, Caruso TJ. The erector spinae plane (ESP) block: A pooled review of 242 cases. J Clin Anesth. 2019 Mar;53:29-34. doi: 10.1016/j.jclinane.2018.09.036. Epub 2018 Oct 3.</citation>
    <PMID>30292068</PMID>
  </reference>
  <reference>
    <citation>Hamilton DL, Manickam B. Erector spinae plane block for pain relief in rib fractures. Br J Anaesth. 2017 Mar 1;118(3):474-475. doi: 10.1093/bja/aex013. No abstract available.</citation>
    <PMID>28203765</PMID>
  </reference>
  <reference>
    <citation>Ueshima H, Otake H. RETRACTED: Clinical experiences of ultrasound-guided erector spinae plane block for thoracic vertebra surgery. J Clin Anesth. 2017 May;38:137. doi: 10.1016/j.jclinane.2016.12.028. Epub 2017 Feb 17. No abstract available.</citation>
    <PMID>28372654</PMID>
  </reference>
  <reference>
    <citation>Luis-Navarro JC, Seda-Guzman M, Luis-Moreno C, Lopez-Romero JL. The erector spinae plane block in 4 cases of video-assisted thoracic surgery. Rev Esp Anestesiol Reanim (Engl Ed). 2018 Apr;65(4):204-208. doi: 10.1016/j.redar.2017.12.004. Epub 2018 Jan 11. English, Spanish.</citation>
    <PMID>29336785</PMID>
  </reference>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <results_first_submitted>April 28, 2023</results_first_submitted>
  <results_first_submitted_qc>June 13, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">July 3, 2023</results_first_posted>
  <last_update_submitted>June 13, 2023</last_update_submitted>
  <last_update_submitted_qc>June 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Charles Luke</investigator_full_name>
    <investigator_title>Clinical Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>VATS</keyword>
  <keyword>Regional Anesthesia</keyword>
  <keyword>Paravertebral nerve block</keyword>
  <keyword>Erector Spinae nerve block</keyword>
  <keyword>Video assisted thoracoscopic surgery</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 28, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/61/NCT03758261/Prot_003.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 3, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/61/NCT03758261/SAP_004.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>January 3, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/61/NCT03758261/ICF_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Erector Spinae Nerve Block</title>
          <description>Erector Spinae nerve block&#xD;
Erector Spinae nerve block: The patient will be placed in a sitting position and the level of needle insertion will be marked corresponding to the level of surgical incision. With sterile technique an ultrasound erector spinae nerve block will be performed.</description>
        </group>
        <group group_id="P2">
          <title>Paravertebral Nerve Block</title>
          <description>Paravertebral nerve block&#xD;
Paravertebral nerve block: The patient will be placed in a sitting position and the level of needle insertion will be marked corresponding to the level of surgical incision. With sterile technique an ultrasound Paravertebral Nerve Block will be performed.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Erector Spinae Nerve Block</title>
          <description>Erector Spinae nerve block&#xD;
Erector Spinae nerve block: The patient will be placed in a sitting position and the level of needle insertion will be marked corresponding to the level of surgical incision. With sterile technique an ultrasound erector spinae nerve block will be performed.</description>
        </group>
        <group group_id="B2">
          <title>Paravertebral Nerve Block</title>
          <description>Paravertebral nerve block&#xD;
Paravertebral nerve block: The patient will be placed in a sitting position and the level of needle insertion will be marked corresponding to the level of surgical incision. With sterile technique an ultrasound Paravertebral Nerve Block will be performed.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="17"/>
            <count group_id="B2" value="16"/>
            <count group_id="B3" value="33"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64.47" spread="13.51"/>
                    <measurement group_id="B2" value="65.94" spread="12.22"/>
                    <measurement group_id="B3" value="65.18" spread="12.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight (kg)</title>
          <units>kilogram (kg)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="79.98" spread="23.04"/>
                    <measurement group_id="B2" value="80.17" spread="17.79"/>
                    <measurement group_id="B3" value="80.07" spread="20.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height (cm)</title>
          <units>centimeter (cm)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="167.35" spread="9.90"/>
                    <measurement group_id="B2" value="165.21" spread="8.69"/>
                    <measurement group_id="B3" value="166.31" spread="9.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28.54" spread="8.33"/>
                    <measurement group_id="B2" value="29.49" spread="5.96"/>
                    <measurement group_id="B3" value="29.00" spread="7.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Total Opioid Consumption</title>
        <description>Morphine equivalents (total OME)</description>
        <time_frame>1 day post catheter removal</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Erector Spinae Nerve Block</title>
            <description>Erector Spinae nerve block&#xD;
Erector Spinae nerve block: The patient will be placed in a sitting position and the level of needle insertion will be marked corresponding to the level of surgical incision. With sterile technique an ultrasound erector spinae nerve block will be performed.</description>
          </group>
          <group group_id="O2">
            <title>Paravertebral Nerve Block</title>
            <description>Paravertebral nerve block&#xD;
Paravertebral nerve block: The patient will be placed in a sitting position and the level of needle insertion will be marked corresponding to the level of surgical incision. With sterile technique an ultrasound Paravertebral Nerve Block will be performed.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Opioid Consumption</title>
          <description>Morphine equivalents (total OME)</description>
          <units>mg morphine equivalent (MME)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="187.36" spread="184.35"/>
                    <measurement group_id="O2" value="164.70" spread="142.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Patient Reported Pain Scores</title>
        <description>Visual analog scale. Scale is from 0 to 10 numerical pain rating scale. 0 indicates no pain. 10 indicates maximum level of pain. Higher scores indicate worse pain level. Pain score will be a single number from 0 to 10.</description>
        <time_frame>1 day post catheter removal</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Erector Spinae Nerve Block</title>
            <description>Erector Spinae nerve block&#xD;
Erector Spinae nerve block: The patient will be placed in a sitting position and the level of needle insertion will be marked corresponding to the level of surgical incision. With sterile technique an ultrasound erector spinae nerve block will be performed.</description>
          </group>
          <group group_id="O2">
            <title>Paravertebral Nerve Block</title>
            <description>Paravertebral nerve block&#xD;
Paravertebral nerve block: The patient will be placed in a sitting position and the level of needle insertion will be marked corresponding to the level of surgical incision. With sterile technique an ultrasound Paravertebral Nerve Block will be performed.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Reported Pain Scores</title>
          <description>Visual analog scale. Scale is from 0 to 10 numerical pain rating scale. 0 indicates no pain. 10 indicates maximum level of pain. Higher scores indicate worse pain level. Pain score will be a single number from 0 to 10.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.98" spread="2.21"/>
                    <measurement group_id="O2" value="5.16" spread="2.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Amount Achieved on Incentive Spirometer</title>
        <description>Amount achieved on incentive spirometer device (mL). Higher level indicates better respiratory effort</description>
        <time_frame>1 day post catheter removal</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Erector Spinae Nerve Block</title>
            <description>Erector Spinae nerve block&#xD;
Erector Spinae nerve block: The patient will be placed in a sitting position and the level of needle insertion will be marked corresponding to the level of surgical incision. With sterile technique an ultrasound erector spinae nerve block will be performed.</description>
          </group>
          <group group_id="O2">
            <title>Paravertebral Nerve Block</title>
            <description>Paravertebral nerve block&#xD;
Paravertebral nerve block: The patient will be placed in a sitting position and the level of needle insertion will be marked corresponding to the level of surgical incision. With sterile technique an ultrasound Paravertebral Nerve Block will be performed.</description>
          </group>
        </group_list>
        <measure>
          <title>Amount Achieved on Incentive Spirometer</title>
          <description>Amount achieved on incentive spirometer device (mL). Higher level indicates better respiratory effort</description>
          <units>milliliter (mL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1221.15" spread="480.77"/>
                    <measurement group_id="O2" value="1187.50" spread="541.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Length of Hospital Stay</title>
        <description>Length of hospital stay post-surgery</description>
        <time_frame>Up to 2 weeks on average</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Erector Spinae Nerve Block</title>
            <description>Erector Spinae nerve block&#xD;
Erector Spinae nerve block: The patient will be placed in a sitting position and the level of needle insertion will be marked corresponding to the level of surgical incision. With sterile technique an ultrasound erector spinae nerve block will be performed.</description>
          </group>
          <group group_id="O2">
            <title>Paravertebral Nerve Block</title>
            <description>Paravertebral nerve block&#xD;
Paravertebral nerve block: The patient will be placed in a sitting position and the level of needle insertion will be marked corresponding to the level of surgical incision. With sterile technique an ultrasound Paravertebral Nerve Block will be performed.</description>
          </group>
        </group_list>
        <measure>
          <title>Length of Hospital Stay</title>
          <description>Length of hospital stay post-surgery</description>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="101.96" spread="49.99"/>
                    <measurement group_id="O2" value="96.30" spread="41.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time Catheter Remains Inserted in Body</title>
        <description>How long catheter remains providing pain relief</description>
        <time_frame>6 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Erector Spinae Nerve Block</title>
            <description>Erector Spinae nerve block&#xD;
Erector Spinae nerve block: The patient will be placed in a sitting position and the level of needle insertion will be marked corresponding to the level of surgical incision. With sterile technique an ultrasound erector spinae nerve block will be performed.</description>
          </group>
          <group group_id="O2">
            <title>Paravertebral Nerve Block</title>
            <description>Paravertebral nerve block&#xD;
Paravertebral nerve block: The patient will be placed in a sitting position and the level of needle insertion will be marked corresponding to the level of surgical incision. With sterile technique an ultrasound Paravertebral Nerve Block will be performed.</description>
          </group>
        </group_list>
        <measure>
          <title>Time Catheter Remains Inserted in Body</title>
          <description>How long catheter remains providing pain relief</description>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.99" spread="12.96"/>
                    <measurement group_id="O2" value="21.94" spread="11.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Averaged Total of Narcotic Usage</title>
        <description>Averaged total Narcotic consumption measured in Oral Morphine Equivalence (OME)</description>
        <time_frame>0-120 hours post-operative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Erector Spinae Nerve Block</title>
            <description>Erector Spinae nerve block&#xD;
Erector Spinae nerve block: The patient will be placed in a sitting position and the level of needle insertion will be marked corresponding to the level of surgical incision. With sterile technique an ultrasound erector spinae nerve block will be performed.</description>
          </group>
          <group group_id="O2">
            <title>Paravertebral Nerve Block</title>
            <description>Paravertebral nerve block&#xD;
Paravertebral nerve block: The patient will be placed in a sitting position and the level of needle insertion will be marked corresponding to the level of surgical incision. With sterile technique an ultrasound Paravertebral Nerve Block will be performed.</description>
          </group>
        </group_list>
        <measure>
          <title>Averaged Total of Narcotic Usage</title>
          <description>Averaged total Narcotic consumption measured in Oral Morphine Equivalence (OME)</description>
          <units>Average of OME</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="187.36" spread="190.82"/>
                    <measurement group_id="O2" value="164.7" spread="147.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Report of Adverse Events From Catheter Placement</title>
        <description>Participant count for patients who experienced adverse events with nerve block catheter placement which includes pneumothorax, infections, bleeding, local anesthetic toxicity.</description>
        <time_frame>1 day post catheter removal</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Erector Spinae Nerve Block</title>
            <description>Erector Spinae nerve block&#xD;
Erector Spinae nerve block: The patient will be placed in a sitting position and the level of needle insertion will be marked corresponding to the level of surgical incision. With sterile technique an ultrasound erector spinae nerve block will be performed.</description>
          </group>
          <group group_id="O2">
            <title>Paravertebral Nerve Block</title>
            <description>Paravertebral nerve block&#xD;
Paravertebral nerve block: The patient will be placed in a sitting position and the level of needle insertion will be marked corresponding to the level of surgical incision. With sterile technique an ultrasound Paravertebral Nerve Block will be performed.</description>
          </group>
        </group_list>
        <measure>
          <title>Report of Adverse Events From Catheter Placement</title>
          <description>Participant count for patients who experienced adverse events with nerve block catheter placement which includes pneumothorax, infections, bleeding, local anesthetic toxicity.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data was collected from time of admission until patient discharge, an average of 4-days.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Erector Spinae Nerve Block</title>
          <description>Erector Spinae nerve block&#xD;
Erector Spinae nerve block: The patient will be placed in a sitting position and the level of needle insertion will be marked corresponding to the level of surgical incision. With sterile technique an ultrasound erector spinae nerve block will be performed.</description>
        </group>
        <group group_id="E2">
          <title>Paravertebral Nerve Block</title>
          <description>Paravertebral nerve block&#xD;
Paravertebral nerve block: The patient will be placed in a sitting position and the level of needle insertion will be marked corresponding to the level of surgical incision. With sterile technique an ultrasound Paravertebral Nerve Block will be performed.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial Fibrillation</sub_title>
                <description>Patient went into atrial fibrillation.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Respiratory Depression</sub_title>
                <description>Respiratory Depression</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Redo Nerve Block</sub_title>
                <description>The patient's nerve block had to be redone.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Charles Luke</name_or_title>
      <organization>University of Pittsburgh Medical Center</organization>
      <phone>4127485589</phone>
      <email>lukecb@upmc.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03758261
org study id: PRO18070064
nct id: NCT03758261
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Continuous paravertebral analgesia and erector spinae plane blockade (ESP) are accepted
      techniques at University of Pittsburgh Medical Center (UPMC) for the management of thoracic
      pain following surgery and trauma. Recently, an increasing number of erector spinae plane
      nerve blocks are being performed as it has been demonstrated in our institution, and via case
      reports that the blocks provide clinical effectiveness, but may have a better side-effect
      profile than the paravertebral nerve block. However, the relative efficacy of ESP compared to
      paravertebral nerve block remains to be established for video assisted thoracoscopic surgery
      (VATS). This is a prospective randomized study intended to assess the efficacy, safety and
      side-effect profile of continuous erector spinae plane analgesia versus continuous
      paravertebral analgesia for VATS procedures. It will include 60 patients presenting to UPMC
      Passavant for a VATS procedure. Patients will be randomized 1:1 to receive either a nerve
      block via continuous paravertebral infusion or via erector spinae plane infusion. In
      addition, to treat breakthrough pain, the patients in both arms will receive multimodal
      adjunctive therapy per routine. Bupivacaine and ropivacaine are FDA approved for use in nerve
      block catheters. The primary outcome will be to compare analgesic efficacy between the two
      nerve blocks as defined by total opioid consumption and pain scores on the numeric pain
      rating scale. Secondary outcomes include incentive spirometer amounts (baseline vs daily
      score postoperatively), length of stay, duration of catheter and report of adverse events or
      complications. Other data points include number of chest tubes and location and level of
      catheter and nerve block placement as well as number of blocks per case.
Background and significance:

      Multimodal analgesia for thoracic surgery is key to allow faster recovery and diminish
      postoperative complications. Paravertebral nerve blocks as well as epidurals are among the
      regional anesthetic techniques utilized for these procedures. Recently, a newer technique,
      the erector spinae plane block, has been used and described to be effective in treating pain
      for patients undergoing thoracic surgery. At UPMC, the investigators have had clinically
      significant pain control for thoracic surgery with both types of blocks. The previous case
      reports/series and our clinical observation has led us to propose this study of comparing the
      clinical efficacy of erector spinae plane block vs. paravertebral nerve block.

      Though ESP and paravertebral blocks have been documented to be efficacious for this
      procedure, there has been no direct comparison between the two approaches. The ESP block is
      considered to be a safer technique with less theoretical adverse events possible and thus,
      would become a viable alternative to the more technically challenging paravertebral nerve
      block. If ESP is found to be superior or non-inferior to paravertebral in terms of pain
      management and safety, this would be a major finding, as ESP is considered safer and
      technically easier to perform than paravertebral nerve block.

      Study design and methods

      The investigators present a prospective randomized trial comparing the efficacy of continuous
      paravertebral nerve blocks vs. ESP blocks for video assisted thoracoscopy surgery (VATS) at
      UPMC Passavant.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 2 groups of patients will be studied simultaneously. One group will have the intervention of the nerve block in the erector spinae approach and the other group will have the nerve block in the traditional paravertebral approach.
primary purpose: Treatment
masking: None (Open Label)
measure: Total Opioid Consumption
time frame: 1 day post catheter removal
description: Morphine equivalents (total OME)
measure: Patient Reported Pain Scores
time frame: 1 day post catheter removal
description: Visual analog scale. Scale is from 0 to 10 numerical pain rating scale. 0 indicates no pain. 10 indicates maximum level of pain. Higher scores indicate worse pain level. Pain score will be a single number from 0 to 10.
measure: Amount Achieved on Incentive Spirometer
time frame: 1 day post catheter removal
description: Amount achieved on incentive spirometer device (mL). Higher level indicates better respiratory effort
measure: Length of Hospital Stay
time frame: Up to 2 weeks on average
description: Length of hospital stay post-surgery
measure: Time Catheter Remains Inserted in Body
time frame: 6 days
description: How long catheter remains providing pain relief
measure: Averaged Total of Narcotic Usage
time frame: 0-120 hours post-operative
description: Averaged total Narcotic consumption measured in Oral Morphine Equivalence (OME)
measure: Report of Adverse Events From Catheter Placement
time frame: 1 day post catheter removal
description: Participant count for patients who experienced adverse events with nerve block catheter placement which includes pneumothorax, infections, bleeding, local anesthetic toxicity.
arm group label: Erector Spinae Nerve Block
arm group type: Other
description: Erector Spinae nerve block
arm group label: Paravertebral Nerve Block
arm group type: Other
description: Paravertebral nerve block
intervention type: Drug
intervention name: Paravertebral nerve block
description: The patient will be placed in a sitting position and the level of needle insertion will be marked corresponding to the level of surgical incision. With sterile technique an ultrasound Paravertebral Nerve Block will be performed.
arm group label: Paravertebral Nerve Block
intervention type: Drug
intervention name: Erector Spinae nerve block
description: The patient will be placed in a sitting position and the level of needle insertion will be marked corresponding to the level of surgical incision. With sterile technique an ultrasound erector spinae nerve block will be performed.
arm group label: Erector Spinae Nerve Block
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Charles Luke, MD
role: Principal Investigator
affiliation: University of Pittsburgh
facility: 
country: United States
citation: D'Ercole F, Arora H, Kumar PA. Paravertebral Block for Thoracic Surgery. J Cardiothorac Vasc Anesth. 2018 Apr;32(2):915-927. doi: 10.1053/j.jvca.2017.10.003. Epub 2017 Oct 4.
PMID: 29169795
citation: Yeung JH, Gates S, Naidu BV, Wilson MJ, Gao Smith F. Paravertebral block versus thoracic epidural for patients undergoing thoracotomy. Cochrane Database Syst Rev. 2016 Feb 21;2(2):CD009121. doi: 10.1002/14651858.CD009121.pub2.
PMID: 26897642
citation: Tsui BCH, Fonseca A, Munshey F, McFadyen G, Caruso TJ. The erector spinae plane (ESP) block: A pooled review of 242 cases. J Clin Anesth. 2019 Mar;53:29-34. doi: 10.1016/j.jclinane.2018.09.036. Epub 2018 Oct 3.
PMID: 30292068
citation: Hamilton DL, Manickam B. Erector spinae plane block for pain relief in rib fractures. Br J Anaesth. 2017 Mar 1;118(3):474-475. doi: 10.1093/bja/aex013. No abstract available.
PMID: 28203765
citation: Ueshima H, Otake H. RETRACTED: Clinical experiences of ultrasound-guided erector spinae plane block for thoracic vertebra surgery. J Clin Anesth. 2017 May;38:137. doi: 10.1016/j.jclinane.2016.12.028. Epub 2017 Feb 17. No abstract available.
PMID: 28372654
citation: Luis-Navarro JC, Seda-Guzman M, Luis-Moreno C, Lopez-Romero JL. The erector spinae plane block in 4 cases of video-assisted thoracic surgery. Rev Esp Anestesiol Reanim (Engl Ed). 2018 Apr;65(4):204-208. doi: 10.1016/j.redar.2017.12.004. Epub 2018 Jan 11. English, Spanish.
PMID: 29336785
responsible party type: Sponsor-Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Charles Luke
investigator title: Clinical Assistant Professor
sharing ipd: No
provided document: 
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 