<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/NCT03280017</url>
  </required_header>
  <id_info>
    <org_study_id>297/2560(EC1)</org_study_id>
    <nct_id>NCT03280017</nct_id>
  </id_info>
  <brief_title>Ketamine With Multilevel Paravertebral Block for Post Video-assisted Thoracic Surgery Pain</brief_title>
  <official_title>Low Dose Intraoperative Intravenous Ketamine in Combination With Multilevel Paravertebral Block for Post Video-assisted Thoracic Surgery Pain: a Randomized Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mahidol University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mahidol University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Postoperative pain after thoracic surgery is associated with adverse outcomes. The current&#xD;
      strategy to prevent postoperative pain is the use of regional anesthesia and analgesic&#xD;
      agents. In video-assisted thoracic surgery (VATS), thoracic paravertebral block has become&#xD;
      the standard analgesic regimen which results in decreased postoperative pain and opioid&#xD;
      consumption.&#xD;
&#xD;
      The investigator would like to study the analgesic efficacy of low dose intravenous ketamine&#xD;
      infusion during surgery in combination with thoracic paravertebral block on postoperative&#xD;
      pain after VATS in a randomized study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Inadequate pain control after thoracic surgery is associated with adverse events such as&#xD;
      postoperative pulmonary complications (PPC), and chronic post surgical pain.&#xD;
&#xD;
      Although the less invasive video-assisted thoracic surgery (VATS) has been used extensively&#xD;
      as it produces optimal surgical outcomes and possible less postoperative pain, there are&#xD;
      reports of inadequate pain control.&#xD;
&#xD;
      Thoracic paravertebral block (TPVB) has been introduced as an effective method in&#xD;
      postoperative pain management after VATS. It is associated with improved pain control and the&#xD;
      reduction of opioid analgesic consumption in several studies.&#xD;
&#xD;
      The use of intravenous low dose ketamine infusion during and after surgery has been shown to&#xD;
      produce superior postoperative pain control in upper abdominal surgery and thoracotomy.&#xD;
&#xD;
      The aim of the present study is to study the efficacy of intravenous low dose ketamine&#xD;
      infusion during surgery on acute and chronic pain after VATS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 25, 2017</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative morphine consumption</measure>
    <time_frame>24 hours postoperatively</time_frame>
    <description>Amount of morphine (in milligrams) which is dispensed from a patient-controlled analgesia device (PCA)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to first analgesia</measure>
    <time_frame>24 hours postoperatively</time_frame>
    <description>Time period (in minutes) after the end of surgery until the time of first morphine solution is dispensed from PCA device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak flow rates (day 1)</measure>
    <time_frame>1 days</time_frame>
    <description>The value of peak flow velocity obtained from the first postoperative day will be compare with the value at the preoperative period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak flow rates (day 2)</measure>
    <time_frame>2 days</time_frame>
    <description>The value of peak flow velocity obtained from the first postoperative day will be compare with the value at the preoperative period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chronic post-surgical pain</measure>
    <time_frame>1 month</time_frame>
    <description>The score of the Thai version of PainDetect questionnaire will be obtained at 1 month postoperatively</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chronic post-surgical pain</measure>
    <time_frame>3 months</time_frame>
    <description>The score of the Thai version of PainDetect questionnaire will be obtained at 3 months postoperatively</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Pain, Acute</condition>
  <condition>Pain, Chronic</condition>
  <condition>Pain, Neuropathic</condition>
  <arm_group>
    <arm_group_label>Ketamine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participant allocated to this arm will receive intravenous ketamine infusion starting after the induction of anesthesia until the end of the surgery at the beginning of skin closure Participant will receive an ultrasound-guide thoracic paravertebral block using 0.5% plain bupivacaine prior to the induction of anesthesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participant allocated to this arm will receive intravenous normal saline solution infusion starting after the induction of anesthesia until the end of the surgery at the beginning of skin closure Participant will receive an ultrasound-guide thoracic paravertebral block using 0.5% plain bupivacaine prior to the induction of anesthesia</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ketamine</intervention_name>
    <description>intravenous ketamine 0.2 mg/kg/hr (concentration 1 mg/ml)</description>
    <arm_group_label>Ketamine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal saline</intervention_name>
    <description>normal saline infusion</description>
    <arm_group_label>Normal saline</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologist physical status 1-3&#xD;
&#xD;
          -  Scheduled for elective video-assisted thoracic surgery&#xD;
&#xD;
          -  Able to operate a patient-controlled analgesia device (PCA)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of morphine allergy&#xD;
&#xD;
          -  History of bupivacaine allergy&#xD;
&#xD;
          -  Contraindication for ketamine infusion&#xD;
&#xD;
          -  Contraindication for thoracic paravertebral block&#xD;
&#xD;
          -  Anticipated postoperative positive pressure ventilation&#xD;
&#xD;
          -  Body mass index more than 35&#xD;
&#xD;
          -  Any known psychiatric disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sirilak Suksompong</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mahidol University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Siriraj Hospital</name>
      <address>
        <city>Bangkok</city>
        <zip>10700</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <reference>
    <citation>Gerner P. Postthoracotomy pain management problems. Anesthesiol Clin. 2008 Jun;26(2):355-67, vii. doi: 10.1016/j.anclin.2008.01.007.</citation>
    <PMID>18456219</PMID>
  </reference>
  <reference>
    <citation>Furrer M, Rechsteiner R, Eigenmann V, Signer C, Althaus U, Ris HB. Thoracotomy and thoracoscopy: postoperative pulmonary function, pain and chest wall complaints. Eur J Cardiothorac Surg. 1997 Jul;12(1):82-7. doi: 10.1016/s1010-7940(97)00105-x.</citation>
    <PMID>9262085</PMID>
  </reference>
  <reference>
    <citation>Agostini P, Cieslik H, Rathinam S, Bishay E, Kalkat MS, Rajesh PB, Steyn RS, Singh S, Naidu B. Postoperative pulmonary complications following thoracic surgery: are there any modifiable risk factors? Thorax. 2010 Sep;65(9):815-8. doi: 10.1136/thx.2009.123083.</citation>
    <PMID>20805178</PMID>
  </reference>
  <reference>
    <citation>Peng Z, Li H, Zhang C, Qian X, Feng Z, Zhu S. A retrospective study of chronic post-surgical pain following thoracic surgery: prevalence, risk factors, incidence of neuropathic component, and impact on qualify of life. PLoS One. 2014 Feb 28;9(2):e90014. doi: 10.1371/journal.pone.0090014. eCollection 2014.</citation>
    <PMID>24587187</PMID>
  </reference>
  <reference>
    <citation>Wildgaard K, Ringsted TK, Hansen HJ, Petersen RH, Werner MU, Kehlet H. Quantitative sensory testing of persistent pain after video-assisted thoracic surgery lobectomy. Br J Anaesth. 2012 Jan;108(1):126-33. doi: 10.1093/bja/aer325. Epub 2011 Oct 5.</citation>
    <PMID>21980121</PMID>
  </reference>
  <reference>
    <citation>Bertrand PC, Regnard JF, Spaggiari L, Levi JF, Magdeleinat P, Guibert L, Levasseur P. Immediate and long-term results after surgical treatment of primary spontaneous pneumothorax by VATS. Ann Thorac Surg. 1996 Jun;61(6):1641-5. doi: 10.1016/0003-4975(96)00190-7.</citation>
    <PMID>8651762</PMID>
  </reference>
  <reference>
    <citation>De Cosmo G, Aceto P, Gualtieri E, Congedo E. Analgesia in thoracic surgery: review. Minerva Anestesiol. 2009 Jun;75(6):393-400. Epub 2008 Oct 27.</citation>
    <PMID>18953284</PMID>
  </reference>
  <reference>
    <citation>Amlong C, Guy M, Schroeder KM, Donnelly MJ. Out-of-plane ultrasound-guided paravertebral blocks improve analgesic outcomes in patients undergoing video-assisted thoracoscopic surgery. Local Reg Anesth. 2015 Dec 15;8:123-8. doi: 10.2147/LRA.S86853. eCollection 2015.</citation>
    <PMID>26730208</PMID>
  </reference>
  <reference>
    <citation>Kaya FN, Turker G, Basagan-Mogol E, Goren S, Bayram S, Gebitekin C. Preoperative multiple-injection thoracic paravertebral blocks reduce postoperative pain and analgesic requirements after video-assisted thoracic surgery. J Cardiothorac Vasc Anesth. 2006 Oct;20(5):639-43. doi: 10.1053/j.jvca.2006.03.022. Epub 2006 Aug 8.</citation>
    <PMID>17023279</PMID>
  </reference>
  <reference>
    <citation>Suzuki M, Haraguti S, Sugimoto K, Kikutani T, Shimada Y, Sakamoto A. Low-dose intravenous ketamine potentiates epidural analgesia after thoracotomy. Anesthesiology. 2006 Jul;105(1):111-9. doi: 10.1097/00000542-200607000-00020.</citation>
    <PMID>16810002</PMID>
  </reference>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>September 10, 2017</study_first_submitted>
  <study_first_submitted_qc>September 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>September 11, 2022</last_update_submitted>
  <last_update_submitted_qc>September 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mahidol University</investigator_affiliation>
    <investigator_full_name>Sirilak Suksompong</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>anesthesia</keyword>
  <keyword>thoracic surgery</keyword>
  <keyword>thoracic paravertebral block</keyword>
  <keyword>ketamine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neuralgia</mesh_term>
    <mesh_term>Acute Pain</mesh_term>
    <mesh_term>Chronic Pain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ketamine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03280017
org study id: 297/2560(EC1)
nct id: NCT03280017
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Postoperative pain after thoracic surgery is associated with adverse outcomes. The current
      strategy to prevent postoperative pain is the use of regional anesthesia and analgesic
      agents. In video-assisted thoracic surgery (VATS), thoracic paravertebral block has become
      the standard analgesic regimen which results in decreased postoperative pain and opioid
      consumption.

      The investigator would like to study the analgesic efficacy of low dose intravenous ketamine
      infusion during surgery in combination with thoracic paravertebral block on postoperative
      pain after VATS in a randomized study.
Inadequate pain control after thoracic surgery is associated with adverse events such as
      postoperative pulmonary complications (PPC), and chronic post surgical pain.

      Although the less invasive video-assisted thoracic surgery (VATS) has been used extensively
      as it produces optimal surgical outcomes and possible less postoperative pain, there are
      reports of inadequate pain control.

      Thoracic paravertebral block (TPVB) has been introduced as an effective method in
      postoperative pain management after VATS. It is associated with improved pain control and the
      reduction of opioid analgesic consumption in several studies.

      The use of intravenous low dose ketamine infusion during and after surgery has been shown to
      produce superior postoperative pain control in upper abdominal surgery and thoracotomy.

      The aim of the present study is to study the efficacy of intravenous low dose ketamine
      infusion during surgery on acute and chronic pain after VATS.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Postoperative morphine consumption
time frame: 24 hours postoperatively
description: Amount of morphine (in milligrams) which is dispensed from a patient-controlled analgesia device (PCA)
measure: Time to first analgesia
time frame: 24 hours postoperatively
description: Time period (in minutes) after the end of surgery until the time of first morphine solution is dispensed from PCA device
measure: Peak flow rates (day 1)
time frame: 1 days
description: The value of peak flow velocity obtained from the first postoperative day will be compare with the value at the preoperative period
measure: Peak flow rates (day 2)
time frame: 2 days
description: The value of peak flow velocity obtained from the first postoperative day will be compare with the value at the preoperative period
measure: Chronic post-surgical pain
time frame: 1 month
description: The score of the Thai version of PainDetect questionnaire will be obtained at 1 month postoperatively
measure: Chronic post-surgical pain
time frame: 3 months
description: The score of the Thai version of PainDetect questionnaire will be obtained at 3 months postoperatively
arm group label: Ketamine
arm group type: Experimental
description: Participant allocated to this arm will receive intravenous ketamine infusion starting after the induction of anesthesia until the end of the surgery at the beginning of skin closure Participant will receive an ultrasound-guide thoracic paravertebral block using 0.5% plain bupivacaine prior to the induction of anesthesia
arm group label: Normal saline
arm group type: Placebo Comparator
description: Participant allocated to this arm will receive intravenous normal saline solution infusion starting after the induction of anesthesia until the end of the surgery at the beginning of skin closure Participant will receive an ultrasound-guide thoracic paravertebral block using 0.5% plain bupivacaine prior to the induction of anesthesia
intervention type: Drug
intervention name: Ketamine
description: intravenous ketamine 0.2 mg/kg/hr (concentration 1 mg/ml)
arm group label: Ketamine
intervention type: Drug
intervention name: Normal saline
description: normal saline infusion
arm group label: Normal saline
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Sirilak Suksompong
role: Principal Investigator
affiliation: Mahidol University
facility: 
country: Thailand
citation: Gerner P. Postthoracotomy pain management problems. Anesthesiol Clin. 2008 Jun;26(2):355-67, vii. doi: 10.1016/j.anclin.2008.01.007.
PMID: 18456219
citation: Furrer M, Rechsteiner R, Eigenmann V, Signer C, Althaus U, Ris HB. Thoracotomy and thoracoscopy: postoperative pulmonary function, pain and chest wall complaints. Eur J Cardiothorac Surg. 1997 Jul;12(1):82-7. doi: 10.1016/s1010-7940(97)00105-x.
PMID: 9262085
citation: Agostini P, Cieslik H, Rathinam S, Bishay E, Kalkat MS, Rajesh PB, Steyn RS, Singh S, Naidu B. Postoperative pulmonary complications following thoracic surgery: are there any modifiable risk factors? Thorax. 2010 Sep;65(9):815-8. doi: 10.1136/thx.2009.123083.
PMID: 20805178
citation: Peng Z, Li H, Zhang C, Qian X, Feng Z, Zhu S. A retrospective study of chronic post-surgical pain following thoracic surgery: prevalence, risk factors, incidence of neuropathic component, and impact on qualify of life. PLoS One. 2014 Feb 28;9(2):e90014. doi: 10.1371/journal.pone.0090014. eCollection 2014.
PMID: 24587187
citation: Wildgaard K, Ringsted TK, Hansen HJ, Petersen RH, Werner MU, Kehlet H. Quantitative sensory testing of persistent pain after video-assisted thoracic surgery lobectomy. Br J Anaesth. 2012 Jan;108(1):126-33. doi: 10.1093/bja/aer325. Epub 2011 Oct 5.
PMID: 21980121
citation: Bertrand PC, Regnard JF, Spaggiari L, Levi JF, Magdeleinat P, Guibert L, Levasseur P. Immediate and long-term results after surgical treatment of primary spontaneous pneumothorax by VATS. Ann Thorac Surg. 1996 Jun;61(6):1641-5. doi: 10.1016/0003-4975(96)00190-7.
PMID: 8651762
citation: De Cosmo G, Aceto P, Gualtieri E, Congedo E. Analgesia in thoracic surgery: review. Minerva Anestesiol. 2009 Jun;75(6):393-400. Epub 2008 Oct 27.
PMID: 18953284
citation: Amlong C, Guy M, Schroeder KM, Donnelly MJ. Out-of-plane ultrasound-guided paravertebral blocks improve analgesic outcomes in patients undergoing video-assisted thoracoscopic surgery. Local Reg Anesth. 2015 Dec 15;8:123-8. doi: 10.2147/LRA.S86853. eCollection 2015.
PMID: 26730208
citation: Kaya FN, Turker G, Basagan-Mogol E, Goren S, Bayram S, Gebitekin C. Preoperative multiple-injection thoracic paravertebral blocks reduce postoperative pain and analgesic requirements after video-assisted thoracic surgery. J Cardiothorac Vasc Anesth. 2006 Oct;20(5):639-43. doi: 10.1053/j.jvca.2006.03.022. Epub 2006 Aug 8.
PMID: 17023279
citation: Suzuki M, Haraguti S, Sugimoto K, Kikutani T, Shimada Y, Sakamoto A. Low-dose intravenous ketamine potentiates epidural analgesia after thoracotomy. Anesthesiology. 2006 Jul;105(1):111-9. doi: 10.1097/00000542-200607000-00020.
PMID: 16810002
responsible party type: Principal Investigator
investigator affiliation: Mahidol University
investigator full name: Sirilak Suksompong
investigator title: Associate Professor
mesh term: Neuralgia
mesh term: Acute Pain
mesh term: Chronic Pain
mesh term: Ketamine
sharing ipd: No