<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/NCT03761433</url>
  </required_header>
  <id_info>
    <org_study_id>SMC2018-11-118</org_study_id>
    <nct_id>NCT03761433</nct_id>
  </id_info>
  <brief_title>Intraoperative Nociception and Postoperative Pain</brief_title>
  <official_title>the Prediction of Postoperative Pain With Surgical Incision Stimulation in the Patients Undergoing Gastrectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Samsung Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Samsung Medical Center</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>
      If the individual patient's pain is assessed and the amount of analgesic needed after surgery&#xD;
      is predicted, appropriate injection of pain control and excessive injection of narcotic&#xD;
      analgesic can be prevented. Therefore, investigators try to evaluate the relation&#xD;
      intraoperative nociception response with postoperative pain score.&#xD;
&#xD;
      In similar anesthetic depth(End tidal sevoflurane 3%) , changes of surgical pleth index&#xD;
      values for stimulus of skin incision are thought to reflect the individual nociception&#xD;
      characteristics.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients who undergoing upper abdominal laparotomy surgery usually experience severe&#xD;
      postoperative pain. Previous studies were reported that preoperative pain, young age,&#xD;
      high-dose remifentanil, and depression were associated with severe postoperative pain.&#xD;
&#xD;
      However, anesthesia-related studies were either retrospective studies or injected with&#xD;
      anesthetic agents in excess of clinical doses to differentiate between groups. There is no&#xD;
      objective indicator for prediction severe postoperative pain.The purpose of this study was to&#xD;
      investigate the relationship between intraoperative pain response and postoperative pain on&#xD;
      standardized surveillance devices.&#xD;
&#xD;
      To maintain the depth of anesthesia, an EEG monitoring device bispectral index (BIS) is used.&#xD;
      Also, surgical pleth index (SPI, GE healthcare, Freiburg, Germany) is a noninvasive&#xD;
      pain-analgesia balance monitoring device that is commercially available to evaluate the state&#xD;
      of pain during general anesthesia. SPI = 100- (0.3 * heart beat interval + 0.7 *&#xD;
      photoplethysmographic pulse wave amplitude) is automatically and continuously calculated from&#xD;
      the waveform of peripheral oxygen saturation.&#xD;
&#xD;
      In similar anesthetic depth(End tidal sevoflurane 3%) , changes of SPI values for stimulus of&#xD;
      skin incision are thought to reflect the individual nociception characteristics. The&#xD;
      investigators hypothesized the higher analgesics consumption can predict with high SPI&#xD;
      response following incisional stimuli.&#xD;
&#xD;
      Thus, investigators try to evaluate the comparison of two groups ( high fentanyl consumption&#xD;
      group vs. low fentanyl consumption group) with intraoperative SPI value (incision and before&#xD;
      aurosal) and hemodynamic parameters under End tidal sevoflurane 3%(anesthesia depth,&#xD;
      hemodynamically stable and appropriate anesthetic depth based on previous studies were&#xD;
      confirmed at the time of skin incision). And the characteristics and emotional status of&#xD;
      patients in two groups are compared.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 30, 2018</start_date>
  <completion_date type="Actual">May 20, 2019</completion_date>
  <primary_completion_date type="Actual">May 20, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The requirement of postoperative analgesics for postoperative 24 hours</measure>
    <time_frame>postoperative 24 hour</time_frame>
    <description>The requirement of postoperative analgesics for postoperative 24 hours (opioid conversion to fentanyl dose mcg)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The immediate postoperative pain score</measure>
    <time_frame>postoperative 24 hour</time_frame>
    <description>The numeric rating pain score, no pain=0 ~ worst pain=10</description>
  </primary_outcome>
  <primary_outcome>
    <measure>intraoperative nociception score (surgical pleth index)</measure>
    <time_frame>intraoperative at the time of skin incision</time_frame>
    <description>under End tidal sevoflurane 3%, surgical pleth index score following surgical incision</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The correlation of requirement of summed postoperative analgesics and intraoperative nociception score</measure>
    <time_frame>postoperative 1 hour</time_frame>
    <description>The consumption of analgesics (opioid conversion to fentanyl dose mcg) and intraoperative surgical pleth index value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The correlation of highest postoperative pain score and intraoperative nociception score</measure>
    <time_frame>postoperative 1 hour</time_frame>
    <description>The postoperative pain score (numeric rating pain score, no pain=0~ worst pain=10)and intraoperative surgical pleth index score</description>
  </secondary_outcome>
  <other_outcome>
    <measure>The expectation of postoperative pain</measure>
    <time_frame>The day before surgery</time_frame>
    <description>The postoperative pain score (numeric rating pain score, no pain=0~ worst pain=10)</description>
  </other_outcome>
  <other_outcome>
    <measure>The expectation of analgesics consumption</measure>
    <time_frame>The day before surgery</time_frame>
    <description>less than average, average, more than average</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>Pain, Postoperative</condition>
  <condition>Nociceptive Pain</condition>
  <condition>Analgesics</condition>
  <arm_group>
    <arm_group_label>SPI group</arm_group_label>
    <description>All patients who received the liver resection surgery will receive surgical pleth index</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SPI group</intervention_name>
    <description>All patients applied surgical pleth index at the time of surgical incision, under End tidal Sevoflurane 3%</description>
    <arm_group_label>SPI group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        the 20-80 year old patients who undergoing lapatotomy gastrectomy at samsung medical center&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -undergoing laparotomy gastrectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  cardiac arrythmia&#xD;
&#xD;
          -  allergic history for drugs&#xD;
&#xD;
          -  renal failure (Cr&gt; 1.5 mg/dl)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Samsung medical center</name>
      <address>
        <city>Seoul</city>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <citation>Robertson TC, Hall K, Bear S, Thompson KJ, Kuwada T, Gersin KS. Transversus abdominis block utilizing liposomal bupivacaine as a non-opioid analgesic for postoperative pain management. Surg Endosc. 2019 Aug;33(8):2657-2662. doi: 10.1007/s00464-018-6543-z. Epub 2018 Nov 2.</citation>
    <PMID>30390161</PMID>
  </reference>
  <reference>
    <citation>Schreiber KL, Martel MO, Shnol H, Shaffer JR, Greco C, Viray N, Taylor LN, McLaughlin M, Brufsky A, Ahrendt G, Bovbjerg D, Edwards RR, Belfer I. Persistent pain in postmastectomy patients: comparison of psychophysical, medical, surgical, and psychosocial characteristics between patients with and without pain. Pain. 2013 May;154(5):660-668. doi: 10.1016/j.pain.2012.11.015. Epub 2012 Dec 5.</citation>
    <PMID>23290256</PMID>
  </reference>
  <reference>
    <citation>Ledowski T, Burke J, Hruby J. Surgical pleth index: prediction of postoperative pain and influence of arousal. Br J Anaesth. 2016 Sep;117(3):371-4. doi: 10.1093/bja/aew226.</citation>
    <PMID>27543532</PMID>
  </reference>
  <reference>
    <citation>Baron-Stefaniak J, Gotz V, Allhutter A, Schiefer J, Hamp T, Faybik P, Berlakovich G, Baron DM, Plochl W. Patients Undergoing Orthotopic Liver Transplantation Require Lower Concentrations of the Volatile Anesthetic Sevoflurane. Anesth Analg. 2017 Sep;125(3):783-789. doi: 10.1213/ANE.0000000000002250.</citation>
    <PMID>28678075</PMID>
  </reference>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>July 10, 2019</last_update_submitted>
  <last_update_submitted_qc>July 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
    <mesh_term>Nociceptive Pain</mesh_term>
  </condition_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/NCT03761433
org study id: SMC2018-11-118
nct id: NCT03761433
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
If the individual patient's pain is assessed and the amount of analgesic needed after surgery
      is predicted, appropriate injection of pain control and excessive injection of narcotic
      analgesic can be prevented. Therefore, investigators try to evaluate the relation
      intraoperative nociception response with postoperative pain score.

      In similar anesthetic depth(End tidal sevoflurane 3%) , changes of surgical pleth index
      values for stimulus of skin incision are thought to reflect the individual nociception
      characteristics.
Patients who undergoing upper abdominal laparotomy surgery usually experience severe
      postoperative pain. Previous studies were reported that preoperative pain, young age,
      high-dose remifentanil, and depression were associated with severe postoperative pain.

      However, anesthesia-related studies were either retrospective studies or injected with
      anesthetic agents in excess of clinical doses to differentiate between groups. There is no
      objective indicator for prediction severe postoperative pain.The purpose of this study was to
      investigate the relationship between intraoperative pain response and postoperative pain on
      standardized surveillance devices.

      To maintain the depth of anesthesia, an EEG monitoring device bispectral index (BIS) is used.
      Also, surgical pleth index (SPI, GE healthcare, Freiburg, Germany) is a noninvasive
      pain-analgesia balance monitoring device that is commercially available to evaluate the state
      of pain during general anesthesia. SPI = 100- (0.3 * heart beat interval + 0.7 *
      photoplethysmographic pulse wave amplitude) is automatically and continuously calculated from
      the waveform of peripheral oxygen saturation.

      In similar anesthetic depth(End tidal sevoflurane 3%) , changes of SPI values for stimulus of
      skin incision are thought to reflect the individual nociception characteristics. The
      investigators hypothesized the higher analgesics consumption can predict with high SPI
      response following incisional stimuli.

      Thus, investigators try to evaluate the comparison of two groups ( high fentanyl consumption
      group vs. low fentanyl consumption group) with intraoperative SPI value (incision and before
      aurosal) and hemodynamic parameters under End tidal sevoflurane 3%(anesthesia depth,
      hemodynamically stable and appropriate anesthetic depth based on previous studies were
      confirmed at the time of skin incision). And the characteristics and emotional status of
      patients in two groups are compared.
observational model: Case-Only
time perspective: Prospective
measure: The requirement of postoperative analgesics for postoperative 24 hours
time frame: postoperative 24 hour
description: The requirement of postoperative analgesics for postoperative 24 hours (opioid conversion to fentanyl dose mcg)
measure: The immediate postoperative pain score
time frame: postoperative 24 hour
description: The numeric rating pain score, no pain=0 ~ worst pain=10
measure: intraoperative nociception score (surgical pleth index)
time frame: intraoperative at the time of skin incision
description: under End tidal sevoflurane 3%, surgical pleth index score following surgical incision
measure: The correlation of requirement of summed postoperative analgesics and intraoperative nociception score
time frame: postoperative 1 hour
description: The consumption of analgesics (opioid conversion to fentanyl dose mcg) and intraoperative surgical pleth index value
measure: The correlation of highest postoperative pain score and intraoperative nociception score
time frame: postoperative 1 hour
description: The postoperative pain score (numeric rating pain score, no pain=0~ worst pain=10)and intraoperative surgical pleth index score
measure: The expectation of postoperative pain
time frame: The day before surgery
description: The postoperative pain score (numeric rating pain score, no pain=0~ worst pain=10)
measure: The expectation of analgesics consumption
time frame: The day before surgery
description: less than average, average, more than average
arm group label: SPI group
description: All patients who received the liver resection surgery will receive surgical pleth index
intervention type: Device
intervention name: SPI group
description: All patients applied surgical pleth index at the time of surgical incision, under End tidal Sevoflurane 3%
arm group label: SPI group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
citation: Robertson TC, Hall K, Bear S, Thompson KJ, Kuwada T, Gersin KS. Transversus abdominis block utilizing liposomal bupivacaine as a non-opioid analgesic for postoperative pain management. Surg Endosc. 2019 Aug;33(8):2657-2662. doi: 10.1007/s00464-018-6543-z. Epub 2018 Nov 2.
PMID: 30390161
citation: Schreiber KL, Martel MO, Shnol H, Shaffer JR, Greco C, Viray N, Taylor LN, McLaughlin M, Brufsky A, Ahrendt G, Bovbjerg D, Edwards RR, Belfer I. Persistent pain in postmastectomy patients: comparison of psychophysical, medical, surgical, and psychosocial characteristics between patients with and without pain. Pain. 2013 May;154(5):660-668. doi: 10.1016/j.pain.2012.11.015. Epub 2012 Dec 5.
PMID: 23290256
citation: Ledowski T, Burke J, Hruby J. Surgical pleth index: prediction of postoperative pain and influence of arousal. Br J Anaesth. 2016 Sep;117(3):371-4. doi: 10.1093/bja/aew226.
PMID: 27543532
citation: Baron-Stefaniak J, Gotz V, Allhutter A, Schiefer J, Hamp T, Faybik P, Berlakovich G, Baron DM, Plochl W. Patients Undergoing Orthotopic Liver Transplantation Require Lower Concentrations of the Volatile Anesthetic Sevoflurane. Anesth Analg. 2017 Sep;125(3):783-789. doi: 10.1213/ANE.0000000000002250.
PMID: 28678075
responsible party type: Sponsor
mesh term: Pain, Postoperative
mesh term: Nociceptive Pain
sharing ipd: No