<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/NCT04482192</url>
  </required_header>
  <id_info>
    <org_study_id>ZU-IRB: 6289</org_study_id>
    <nct_id>NCT04482192</nct_id>
  </id_info>
  <brief_title>Continuous Paravertebral Block by Intraoperative Direct Access Versus Systemic Analgesia for Postthoracotomy Pain Relief</brief_title>
  <official_title>Continuous Paravertebral Block by Intraoperative Direct Access Versus Systemic Analgesia for Postthoracotomy Pain Relief</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zagazig University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zagazig University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      to evaluate the safety and efficacy of continuous paravertebral block by intraoperative&#xD;
      direct access on postthoracotomy pain compared to systemic analgesia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Based on a pilot study of 20 participants, 10 in each group, the mean visual analogue score&#xD;
      of pain at rest (VAS) ± Standard Deviation (SD) at 6 hours postoperatively for Thoracic&#xD;
      paravertebral block group (TPVB) participants were 3.0 ± 1.4 and that for systemic analgesia&#xD;
      (SA) participants were 4.2 ± 1.6. The calculated significant sample size with a power of 0.85&#xD;
      and alpha error of 0.05 was 60 participants, with 1:1 allocation in each group.&#xD;
&#xD;
      Eighty two participants were assessed for eligibility criteria to be included in the study,&#xD;
      18 participants were excluded pre-randomization, and one participant was excluded&#xD;
      post-randomization due to re-exploration for bleeding. Sixty three participants were analyzed&#xD;
      in the study. Thoracic paravertebral block group (TPVB group) included 32 participants and&#xD;
      systemic analgesia group (SA group) included 31 participants.&#xD;
&#xD;
      Technique of intraoperative paravertebral catheter insertion:&#xD;
&#xD;
      The investigators used the technique that was described by Sabanathan et al in 1988[14] and&#xD;
      modified by them in 1990 [15]. After completing the surgical pulmonary procedure and with the&#xD;
      chest is still open, starting from the posterior end of the thoracotomy, parietal pleura is&#xD;
      raised from the posterior chest wall to the vertebral body and for two spaces above and below&#xD;
      the incision of thoracotomy creating a pouch. A 16-gauge disposable Tuohy needle is inserted&#xD;
      percutaneously through a low posterior interspace. The needle is advanced until the tip&#xD;
      appeared in the created pouch. The stylet is removed, and a 16-gauge side-holed epidural&#xD;
      catheter is advanced into the created pouch and the needle is withdrawn. Using a curved&#xD;
      forceps, a small defect is done in the extrapleural fascia to be directly in the&#xD;
      paravertebral space. The cannula is passed to the paravertebral space through the defect and&#xD;
      advanced cranially for 2 to 3 cm. The parietal pleura is reattached to the posterior edge of&#xD;
      the wound and the catheter is secured. Then a bolus dose 15-20 ml of 1% lidocaine is injected&#xD;
      through the catheter and the chest is closed as usual with one or two intercostal drainage&#xD;
      tubes according to the surgical procedure.&#xD;
&#xD;
      Protocol of analgesia:&#xD;
&#xD;
      All participants, in both groups, received intravenous analgesia with 1gm paracetamol and 30&#xD;
      mg ketorolac half an hour before the end of surgery.&#xD;
&#xD;
      Systemic analgesia (SA) group continue to receive 1gm paracetamol and 30 mg ketorolac by&#xD;
      intravenous infusion every 6 hours for 3 days. Thoracic paravertebral block (TPVB) group&#xD;
      received continuous infusion of 0.1 ml/kg/h of 1.0% lidocaine (l mg/kg/h) using infusion pump&#xD;
      through the inserted paravertebral catheter for 3 days. Intravenous morphine sulfate&#xD;
      (0.05mg/kg) was given as a rescue medication if the VAS ≥ 4 for both groups. A senior nurse&#xD;
      was responsible for handling the analgesia regimen and another nurse was responsible for&#xD;
      recording pain score on visual analogue scale (VAS) and morphine consumption, as scheduled.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 15, 2015</start_date>
  <completion_date type="Actual">March 31, 2020</completion_date>
  <primary_completion_date type="Actual">January 31, 2020</primary_completion_date>
  <phase>Phase 3</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain score on visual analogue scale (VAS) at rest</measure>
    <time_frame>24 hours after operation</time_frame>
    <description>Paper-based visual analogue scale (VAS) is used for pain assessment. It provides a range of scores from 0-10. A higher score indicates greater pain intensity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain score on visual analogue scale (VAS) on coughing</measure>
    <time_frame>24 hours after operation</time_frame>
    <description>Paper-based visual analogue scale (VAS) is used for pain assessment. It provides a range of scores from 0-10. A higher score indicates greater pain intensity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total morphine consumption</measure>
    <time_frame>end of first postoperative day</time_frame>
    <description>The summation of morphine consumption of the participant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Forced vital capacity (FVC)</measure>
    <time_frame>24 hours after operation</time_frame>
    <description>measured by spirometer (Microspiro HI-298, Chest Corporation, Tokyo, Japan)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Forced expiratory volume in 1s (FEV1)</measure>
    <time_frame>24 hours after operation</time_frame>
    <description>measured by spirometer (Microspiro HI-298, Chest Corporation, Tokyo, Japan)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak expiratory flow rate (PEFR)</measure>
    <time_frame>24 hours after operation</time_frame>
    <description>measured by spirometer (Microspiro HI-298, Chest Corporation, Tokyo, Japan)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">63</enrollment>
  <condition>Post Thoracotomy Pain</condition>
  <arm_group>
    <arm_group_label>Thoracic paravertebral block group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Continuous thoracic paravertebral block with 1% lidocaine infusion for 3 postoperative days through a paravertebral catheter inserted intraoperatively by the surgeon.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Systemic analgesia group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patients in this group will receive paracetamol and ketorolac by intravenous infusion every 6 hours for 3 postoperative days</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Thoracic paravertebral block</intervention_name>
    <description>After ending pulmonary procedure, a pleural pouch created beside vertebral column, a catheter is inserted to the pouch for continuous infusion of 1% lidocaine for 3 postoperative days. Intravenous morphine sulfate (0.05mg/kg) was given as a rescue medication if the VAS ≥ 4.</description>
    <arm_group_label>Thoracic paravertebral block group</arm_group_label>
    <other_name>Study group</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Systemic analgesia</intervention_name>
    <description>Systemic analgesia (SA) group receive 1gm paracetamol and 30 mg ketorolac by intravenous infusion every 6 hours for 3 days. Intravenous morphine sulfate (0.05mg/kg) was given as a rescue medication if the VAS ≥ 4.</description>
    <arm_group_label>Systemic analgesia group</arm_group_label>
    <other_name>Control group</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Elective posterolateral thoracotomy surgery&#xD;
&#xD;
               -  American Society of Anesthesiologists (ASA) physical status of II and III&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • lack of patient consent.&#xD;
&#xD;
               -  patients younger than 18 years,&#xD;
&#xD;
               -  emergency surgery,&#xD;
&#xD;
               -  previous thoracotomy,&#xD;
&#xD;
               -  drug addiction,&#xD;
&#xD;
               -  allergy to paracetamol (acetaminophen) or ketorolac,&#xD;
&#xD;
               -  coagulopathy,&#xD;
&#xD;
               -  hepatic dysfunction,&#xD;
&#xD;
               -  chronic renal failure,&#xD;
&#xD;
               -  history of gastric ulcer&#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>Ahmed Deebis, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zagazig University</affiliation>
  </overall_official>
  <link>
    <url>http://www.esraeurope.org/prospect</url>
    <description>Procedure specific postoperative pain management. (2015) Thoracotomy.</description>
  </link>
  <results_reference>
    <citation>Krakowski JC, Arora H. Con: Thoracic Epidural Block Is Not Superior to Paravertebral Blocks for Open Thoracic Surgery. J Cardiothorac Vasc Anesth. 2015 Dec;29(6):1720-2. doi: 10.1053/j.jvca.2015.06.012. Epub 2015 Jun 10. No abstract available.</citation>
    <PMID>26386503</PMID>
  </results_reference>
  <results_reference>
    <citation>Fortier S, Hanna HA, Bernard A, Girard C. Comparison between systemic analgesia, continuous wound catheter analgesia and continuous thoracic paravertebral block: a randomised, controlled trial of postthoracotomy pain management. Eur J Anaesthesiol. 2012 Nov;29(11):524-30. doi: 10.1097/EJA.0b013e328357e5a1.</citation>
    <PMID>22914044</PMID>
  </results_reference>
  <results_reference>
    <citation>Sabanathan S, Smith PJ, Pradhan GN, Hashimi H, Eng JB, Mearns AJ. Continuous intercostal nerve block for pain relief after thoracotomy. Ann Thorac Surg. 1988 Oct;46(4):425-6. doi: 10.1016/s0003-4975(10)64657-7.</citation>
    <PMID>3178353</PMID>
  </results_reference>
  <results_reference>
    <citation>Berrisford RG, Sabanathan SS. Direct access to the paravertebral space at thoracotomy. Ann Thorac Surg. 1990 May;49(5):854. doi: 10.1016/0003-4975(90)90058-e. No abstract available.</citation>
    <PMID>2339953</PMID>
  </results_reference>
  <results_reference>
    <citation>Wojtys ME, Wasikowski J, Wojcik N, Wojcik J, Wasilewski P, Lisowski P, Grodzki T. Assessment of postoperative pain management and comparison of effectiveness of pain relief treatment involving paravertebral block and thoracic epidural analgesia in patients undergoing posterolateral thoracotomy. J Cardiothorac Surg. 2019 Apr 16;14(1):78. doi: 10.1186/s13019-019-0901-3.</citation>
    <PMID>30992044</PMID>
  </results_reference>
  <results_reference>
    <citation>Elia N, Lysakowski C, Tramer MR. Does multimodal analgesia with acetaminophen, nonsteroidal antiinflammatory drugs, or selective cyclooxygenase-2 inhibitors and patient-controlled analgesia morphine offer advantages over morphine alone? Meta-analyses of randomized trials. Anesthesiology. 2005 Dec;103(6):1296-304. doi: 10.1097/00000542-200512000-00025.</citation>
    <PMID>16306743</PMID>
  </results_reference>
  <results_reference>
    <citation>Batra RK, Krishnan K, Agarwal A. Paravertebral block. J Anaesthesiol Clin Pharmacol. 2011 Jan;27(1):5-11. No abstract available.</citation>
    <PMID>21804697</PMID>
  </results_reference>
  <results_reference>
    <citation>Katayama T, Hirai S, Kobayashi R, Hamaishi M, Okada T, Mitsui N. Safety of the paravertebral block in patients ineligible for epidural block undergoing pulmonary resection. Gen Thorac Cardiovasc Surg. 2012 Dec;60(12):811-4. doi: 10.1007/s11748-012-0149-5. Epub 2012 Sep 16.</citation>
    <PMID>22983833</PMID>
  </results_reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>July 21, 2020</last_update_submitted>
  <last_update_submitted_qc>July 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zagazig University</investigator_affiliation>
    <investigator_full_name>Ahmed Deebis</investigator_full_name>
    <investigator_title>Professor cardiothoracic surgery</investigator_title>
  </responsible_party>
  <keyword>Paravertebral block</keyword>
  <keyword>Postthoracotomy analgesia</keyword>
  <keyword>Systemic analgesia</keyword>
  <keyword>Lidocaine infusion</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All authors of the study will share individual participant data (IPD)</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>after ending total collection of data till ending of writing the manuscript</ipd_time_frame>
    <ipd_access_criteria>personal communication</ipd_access_criteria>
  </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/NCT04482192
org study id: ZU-IRB: 6289
nct id: NCT04482192
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
to evaluate the safety and efficacy of continuous paravertebral block by intraoperative
      direct access on postthoracotomy pain compared to systemic analgesia.
Based on a pilot study of 20 participants, 10 in each group, the mean visual analogue score
      of pain at rest (VAS) ± Standard Deviation (SD) at 6 hours postoperatively for Thoracic
      paravertebral block group (TPVB) participants were 3.0 ± 1.4 and that for systemic analgesia
      (SA) participants were 4.2 ± 1.6. The calculated significant sample size with a power of 0.85
      and alpha error of 0.05 was 60 participants, with 1:1 allocation in each group.

      Eighty two participants were assessed for eligibility criteria to be included in the study,
      18 participants were excluded pre-randomization, and one participant was excluded
      post-randomization due to re-exploration for bleeding. Sixty three participants were analyzed
      in the study. Thoracic paravertebral block group (TPVB group) included 32 participants and
      systemic analgesia group (SA group) included 31 participants.

      Technique of intraoperative paravertebral catheter insertion:

      The investigators used the technique that was described by Sabanathan et al in 1988[14] and
      modified by them in 1990 [15]. After completing the surgical pulmonary procedure and with the
      chest is still open, starting from the posterior end of the thoracotomy, parietal pleura is
      raised from the posterior chest wall to the vertebral body and for two spaces above and below
      the incision of thoracotomy creating a pouch. A 16-gauge disposable Tuohy needle is inserted
      percutaneously through a low posterior interspace. The needle is advanced until the tip
      appeared in the created pouch. The stylet is removed, and a 16-gauge side-holed epidural
      catheter is advanced into the created pouch and the needle is withdrawn. Using a curved
      forceps, a small defect is done in the extrapleural fascia to be directly in the
      paravertebral space. The cannula is passed to the paravertebral space through the defect and
      advanced cranially for 2 to 3 cm. The parietal pleura is reattached to the posterior edge of
      the wound and the catheter is secured. Then a bolus dose 15-20 ml of 1% lidocaine is injected
      through the catheter and the chest is closed as usual with one or two intercostal drainage
      tubes according to the surgical procedure.

      Protocol of analgesia:

      All participants, in both groups, received intravenous analgesia with 1gm paracetamol and 30
      mg ketorolac half an hour before the end of surgery.

      Systemic analgesia (SA) group continue to receive 1gm paracetamol and 30 mg ketorolac by
      intravenous infusion every 6 hours for 3 days. Thoracic paravertebral block (TPVB) group
      received continuous infusion of 0.1 ml/kg/h of 1.0% lidocaine (l mg/kg/h) using infusion pump
      through the inserted paravertebral catheter for 3 days. Intravenous morphine sulfate
      (0.05mg/kg) was given as a rescue medication if the VAS ≥ 4 for both groups. A senior nurse
      was responsible for handling the analgesia regimen and another nurse was responsible for
      recording pain score on visual analogue scale (VAS) and morphine consumption, as scheduled.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: Pain score on visual analogue scale (VAS) at rest
time frame: 24 hours after operation
description: Paper-based visual analogue scale (VAS) is used for pain assessment. It provides a range of scores from 0-10. A higher score indicates greater pain intensity.
measure: Pain score on visual analogue scale (VAS) on coughing
time frame: 24 hours after operation
description: Paper-based visual analogue scale (VAS) is used for pain assessment. It provides a range of scores from 0-10. A higher score indicates greater pain intensity.
measure: Total morphine consumption
time frame: end of first postoperative day
description: The summation of morphine consumption of the participant
measure: Forced vital capacity (FVC)
time frame: 24 hours after operation
description: measured by spirometer (Microspiro HI-298, Chest Corporation, Tokyo, Japan)
measure: Forced expiratory volume in 1s (FEV1)
time frame: 24 hours after operation
description: measured by spirometer (Microspiro HI-298, Chest Corporation, Tokyo, Japan)
measure: Peak expiratory flow rate (PEFR)
time frame: 24 hours after operation
description: measured by spirometer (Microspiro HI-298, Chest Corporation, Tokyo, Japan)
arm group label: Thoracic paravertebral block group
arm group type: Active Comparator
description: Continuous thoracic paravertebral block with 1% lidocaine infusion for 3 postoperative days through a paravertebral catheter inserted intraoperatively by the surgeon.
arm group label: Systemic analgesia group
arm group type: Active Comparator
description: patients in this group will receive paracetamol and ketorolac by intravenous infusion every 6 hours for 3 postoperative days
intervention type: Combination Product
intervention name: Thoracic paravertebral block
description: After ending pulmonary procedure, a pleural pouch created beside vertebral column, a catheter is inserted to the pouch for continuous infusion of 1% lidocaine for 3 postoperative days. Intravenous morphine sulfate (0.05mg/kg) was given as a rescue medication if the VAS ≥ 4.
arm group label: Thoracic paravertebral block group
other name: Study group
intervention type: Drug
intervention name: Systemic analgesia
description: Systemic analgesia (SA) group receive 1gm paracetamol and 30 mg ketorolac by intravenous infusion every 6 hours for 3 days. Intravenous morphine sulfate (0.05mg/kg) was given as a rescue medication if the VAS ≥ 4.
arm group label: Systemic analgesia group
other name: Control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ahmed Deebis, MD
role: Principal Investigator
affiliation: Zagazig University
url: http://www.esraeurope.org/prospect
description: Procedure specific postoperative pain management. (2015) Thoracotomy.
citation: Krakowski JC, Arora H. Con: Thoracic Epidural Block Is Not Superior to Paravertebral Blocks for Open Thoracic Surgery. J Cardiothorac Vasc Anesth. 2015 Dec;29(6):1720-2. doi: 10.1053/j.jvca.2015.06.012. Epub 2015 Jun 10. No abstract available.
PMID: 26386503
citation: Fortier S, Hanna HA, Bernard A, Girard C. Comparison between systemic analgesia, continuous wound catheter analgesia and continuous thoracic paravertebral block: a randomised, controlled trial of postthoracotomy pain management. Eur J Anaesthesiol. 2012 Nov;29(11):524-30. doi: 10.1097/EJA.0b013e328357e5a1.
PMID: 22914044
citation: Sabanathan S, Smith PJ, Pradhan GN, Hashimi H, Eng JB, Mearns AJ. Continuous intercostal nerve block for pain relief after thoracotomy. Ann Thorac Surg. 1988 Oct;46(4):425-6. doi: 10.1016/s0003-4975(10)64657-7.
PMID: 3178353
citation: Berrisford RG, Sabanathan SS. Direct access to the paravertebral space at thoracotomy. Ann Thorac Surg. 1990 May;49(5):854. doi: 10.1016/0003-4975(90)90058-e. No abstract available.
PMID: 2339953
citation: Wojtys ME, Wasikowski J, Wojcik N, Wojcik J, Wasilewski P, Lisowski P, Grodzki T. Assessment of postoperative pain management and comparison of effectiveness of pain relief treatment involving paravertebral block and thoracic epidural analgesia in patients undergoing posterolateral thoracotomy. J Cardiothorac Surg. 2019 Apr 16;14(1):78. doi: 10.1186/s13019-019-0901-3.
PMID: 30992044
citation: Elia N, Lysakowski C, Tramer MR. Does multimodal analgesia with acetaminophen, nonsteroidal antiinflammatory drugs, or selective cyclooxygenase-2 inhibitors and patient-controlled analgesia morphine offer advantages over morphine alone? Meta-analyses of randomized trials. Anesthesiology. 2005 Dec;103(6):1296-304. doi: 10.1097/00000542-200512000-00025.
PMID: 16306743
citation: Batra RK, Krishnan K, Agarwal A. Paravertebral block. J Anaesthesiol Clin Pharmacol. 2011 Jan;27(1):5-11. No abstract available.
PMID: 21804697
citation: Katayama T, Hirai S, Kobayashi R, Hamaishi M, Okada T, Mitsui N. Safety of the paravertebral block in patients ineligible for epidural block undergoing pulmonary resection. Gen Thorac Cardiovasc Surg. 2012 Dec;60(12):811-4. doi: 10.1007/s11748-012-0149-5. Epub 2012 Sep 16.
PMID: 22983833
responsible party type: Principal Investigator
investigator affiliation: Zagazig University
investigator full name: Ahmed Deebis
investigator title: Professor cardiothoracic surgery
sharing ipd: Yes
ipd description: All authors of the study will share individual participant data (IPD)
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: after ending total collection of data till ending of writing the manuscript
ipd access criteria: personal communication