xml: <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/NCT06011746</url>
    </required_header>
    <id_info>
      <org_study_id>36264PR244/6/23</org_study_id>
      <nct_id>NCT06011746</nct_id>
    </id_info>
    <brief_title>Adding Ketamine to Levobupivacaine in Paravertebral Block in Thoracotomy</brief_title>
    <official_title>Efficacy of Adding Ketamine to Levobupivacaine in Paravertebral Block on Acute and Chronic Pain in Thoracotomy: a Randomized Controlled Double-blinded Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tanta University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tanta 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 role of adding ketamine to levobupivacaine in PVB on acute and chronic pain&#xD;
        in thoracotomy&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Several adjuvants have been added to them to enhance the effects of those blocks.&#xD;
        Dexamethasone, morphine, dexmedetomidine, clonidine, ketamine, and magnesium sulphate are&#xD;
        some of them. results are variable.&#xD;
  &#xD;
        Ketamine blocks N-Methyl-D-Aspartate (NMDA) receptors in the spinal cord. It is also&#xD;
        considered to influence voltage sensitive Calcium ions channels, opioid receptors, and&#xD;
        monoaminergic receptors. Therefore, it is considered overall to affect nociception.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 30, 2023</start_date>
    <completion_date type="Anticipated">December 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 30, 2023</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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Time to first analgesia</measure>
      <time_frame>24 hour postoperatively</time_frame>
      <description>The time till the first rescue of analgesia of morphine. Patients can receive incremental doses of morphine 3 mg intravenously as rescue analgesia if the numeric rating scale (NRS) pain score is &gt; 3.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Total amount of morphine consumption</measure>
      <time_frame>24 hour postoperatively</time_frame>
      <description>The total morphine consumption in the 1st 24h postoperative will be recorded. Patients can receive incremental doses of meperidine 0.5 mg/kg intravenously as rescue analgesia if the numeric rating scale (NRS) pain score is &gt; 3.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain intensity during rest</measure>
      <time_frame>48 hour postoperatively</time_frame>
      <description>Postoperative pain using numeric rating scale at rest and during coughing or movement will be measured at Post-anesthesia care unit, 1h, 2h. 4hr, 6h, 8h, 12h, 18h, 24h, 36h and 48h postoperative.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain intensity during deep breathing</measure>
      <time_frame>48 hour postoperatively</time_frame>
      <description>Postoperative pain using numeric rating scale at rest and during coughing or movement will be measured at Post-anesthesia care unit, 1h, 2h. 4hr, 6h, 8h, 12h, 18h, 24h, 36h and 48h postoperative.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of chronic pain</measure>
      <time_frame>three months postoperatively</time_frame>
      <description>The neuropathic PTPS cases were screened using the grading system for neuropathic pain (GSNP). Positive cases of PTPS with a neuropathic component were grade 2 (probable) or 3 (definite), that is, GSNP ≥2</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Ketamine</condition>
    <condition>Levobupivacaine</condition>
    <condition>Paravertebral Block</condition>
    <condition>Acute Pain</condition>
    <condition>Chronic Pain</condition>
    <arm_group>
      <arm_group_label>Ketamine Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>patients will receive paravertebral block (19 mL of 0.5% levobupivacaine + 1 ml ketamine (50 mg)).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>patients will receive paravertebral block (19 mL of 0.5% levobupivacaine + 1 ml normal saline)</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Ketamine + Levobupivacaine</intervention_name>
      <description>Skin infiltration will be done using 3 ml lidocaine 2% and a 22-gauage block needle will be advanced using the in-plane approach craniocaudally. Once the costotransverse ligament is reached, negative aspiration of blood and air will be confirmed. Under ultrasound visualization, 19 mL of 0.5% levobupivacaine with 1ml ketamine (50mg)</description>
      <arm_group_label>Ketamine Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Levobupivacaine</intervention_name>
      <description>Skin infiltration will be done using 3 ml lidocaine 2% and a 22-gauage block needle will be advanced using the in-plane approach craniocaudally. Once the costotransverse ligament is reached, negative aspiration of blood and air will be confirmed. Under ultrasound visualization, 19 mL of 0.5% levobupivacaine with (50mg) or normal saline</description>
      <arm_group_label>Control Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 18-75 years.&#xD;
  &#xD;
            -  Both sexes.&#xD;
  &#xD;
            -  ASA (American Society of Anesthesiology) physical status II-III.&#xD;
  &#xD;
            -  Scheduled for open thoracotomy.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Contraindications to or failed paravertebral block .&#xD;
  &#xD;
            -  Body mass index (BMI) &gt;35 kg/m2.&#xD;
  &#xD;
            -  The likelihood of postoperative mechanical ventilation.&#xD;
  &#xD;
            -  Patients with coagulopathy, poorly controlled diabetes mellitus, depression or other&#xD;
               psychiatric disorders that required antidepressant drugs, alcohol, or recreational&#xD;
               drug addiction.&#xD;
  &#xD;
            -  Hypersensitivity to ketamine or levobupivacaine.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Tanta University</name>
        <address>
          <city>Tanta</city>
          <state>El-Gharbia</state>
          <zip>31527</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Mohammed S Elsharkawy</last_name>
        <phone>+20 114 820 7870</phone>
        <email>mselsharkawy@med.tanta.edu.eg</email>
      </contact>
      <investigator>
        <last_name>Saad A Moharam, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 13, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Tanta University</investigator_affiliation>
      <investigator_full_name>Mohammed Said ElSharkawy</investigator_full_name>
      <investigator_title>Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine Faculty of Medicine Tanta University</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Chronic Pain</mesh_term>
      <mesh_term>Acute Pain</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Ketamine</mesh_term>
      <mesh_term>Levobupivacaine</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The data will be available upon a reasonable request from the corresponding author after the end of study for one year.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>after the end of study for one year.</ipd_time_frame>
      <ipd_access_criteria>The data will be available upon a reasonable request from the corresponding author</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06011746
  org study id: 36264PR244/6/23
  nct id: NCT06011746
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  To evaluate the role of adding ketamine to levobupivacaine in PVB on acute and chronic pain
        in thoracotomy
  Several adjuvants have been added to them to enhance the effects of those blocks.
        Dexamethasone, morphine, dexmedetomidine, clonidine, ketamine, and magnesium sulphate are
        some of them. results are variable.
  
        Ketamine blocks N-Methyl-D-Aspartate (NMDA) receptors in the spinal cord. It is also
        considered to influence voltage sensitive Calcium ions channels, opioid receptors, and
        monoaminergic receptors. Therefore, it is considered overall to affect nociception.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  measure: Time to first analgesia
  time frame: 24 hour postoperatively
  description: The time till the first rescue of analgesia of morphine. Patients can receive incremental doses of morphine 3 mg intravenously as rescue analgesia if the numeric rating scale (NRS) pain score is > 3.
  measure: Total amount of morphine consumption
  time frame: 24 hour postoperatively
  description: The total morphine consumption in the 1st 24h postoperative will be recorded. Patients can receive incremental doses of meperidine 0.5 mg/kg intravenously as rescue analgesia if the numeric rating scale (NRS) pain score is > 3.
  measure: Pain intensity during rest
  time frame: 48 hour postoperatively
  description: Postoperative pain using numeric rating scale at rest and during coughing or movement will be measured at Post-anesthesia care unit, 1h, 2h. 4hr, 6h, 8h, 12h, 18h, 24h, 36h and 48h postoperative.
  measure: Pain intensity during deep breathing
  time frame: 48 hour postoperatively
  description: Postoperative pain using numeric rating scale at rest and during coughing or movement will be measured at Post-anesthesia care unit, 1h, 2h. 4hr, 6h, 8h, 12h, 18h, 24h, 36h and 48h postoperative.
  measure: Incidence of chronic pain
  time frame: three months postoperatively
  description: The neuropathic PTPS cases were screened using the grading system for neuropathic pain (GSNP). Positive cases of PTPS with a neuropathic component were grade 2 (probable) or 3 (definite), that is, GSNP ≥2
  arm group label: Ketamine Group
  arm group type: Experimental
  description: patients will receive paravertebral block (19 mL of 0.5% levobupivacaine + 1 ml ketamine (50 mg)).
  arm group label: Control Group
  arm group type: Active Comparator
  description: patients will receive paravertebral block (19 mL of 0.5% levobupivacaine + 1 ml normal saline)
  intervention type: Drug
  intervention name: Ketamine + Levobupivacaine
  description: Skin infiltration will be done using 3 ml lidocaine 2% and a 22-gauage block needle will be advanced using the in-plane approach craniocaudally. Once the costotransverse ligament is reached, negative aspiration of blood and air will be confirmed. Under ultrasound visualization, 19 mL of 0.5% levobupivacaine with 1ml ketamine (50mg)
  arm group label: Ketamine Group
  intervention type: Drug
  intervention name: Levobupivacaine
  description: Skin infiltration will be done using 3 ml lidocaine 2% and a 22-gauage block needle will be advanced using the in-plane approach craniocaudally. Once the costotransverse ligament is reached, negative aspiration of blood and air will be confirmed. Under ultrasound visualization, 19 mL of 0.5% levobupivacaine with (50mg) or normal saline
  arm group label: Control Group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Tanta University
  investigator full name: Mohammed Said ElSharkawy
  investigator title: Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine Faculty of Medicine Tanta University
  mesh term: Chronic Pain
  mesh term: Acute Pain
  mesh term: Ketamine
  mesh term: Levobupivacaine
  sharing ipd: Yes
  ipd description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
  ipd info type: Study Protocol
  ipd time frame: after the end of study for one year.
  ipd access criteria: The data will be available upon a reasonable request from the corresponding author