<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/NCT03782896</url>
  </required_header>
  <id_info>
    <org_study_id>SMC2018-09-029-003</org_study_id>
    <nct_id>NCT03782896</nct_id>
  </id_info>
  <brief_title>The Effects of Anesthetics on Persistent Pain Following Breast Cancer Surgery</brief_title>
  <official_title>The Effects of Anesthetics on Persistent Pain Following Breast Cancer Surgery</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>
      Persistent postoperative pain occurs up to 25 to 60 % after mastectomy. This occurs at a&#xD;
      higher frequency than the rate of invasive surgery.Therefore, many ways have been tried to&#xD;
      study risk factors. A study was conducted to predict postoperative pain for items&#xD;
      (preoperative pain, sensitivity, pain prediction). As a result, it was reported that the&#xD;
      scope of surgery, pre-operative pain, young age, and depression were associated with&#xD;
      persistent pain.&#xD;
&#xD;
      This study try to find out whether persistent pain after mastectomy is affected anesthetic&#xD;
      factors appropriate anesthesia depth and opioid using standardized monitoring devices limited&#xD;
      to similar surgical ranges.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Persistent postoperative pain occurs up to 25 to 60 % after mastectomy. This occurs at a&#xD;
      higher frequency than the rate of invasive surgery.Therefore, many ways have been tried to&#xD;
      study risk factors. A study was conducted to predict postoperative pain for items&#xD;
      (preoperative pain, sensitivity, pain prediction). As a result, it was reported that the&#xD;
      scope of surgery, pre-operative pain, young age, and depression were associated with&#xD;
      persistent pain.&#xD;
&#xD;
      There were reports of no association with anesthesia in the area of anesthesia to the high&#xD;
      pain control requirement in the postoperative recovery room, 24 hours of high pain&#xD;
      medication, use of inhalation agent, and a high dosage of remifentanil. However, an&#xD;
      anesthesia-related study was either a retrospective study or anesthetic was injected with&#xD;
      more than a clinical dose in order to make the difference following methods.&#xD;
&#xD;
      In this study, bispectral index is used to maintain anesthesia depth. In addition, the&#xD;
      commercially available noninvasive pain depth equipment (Surgical Pleth Index) is used to&#xD;
      assess the nociception-antinociception balance. Displays the automatically calculated values&#xD;
      of SPI=100-(0.3*heartbeat interval + 0.7*photoplethysmographic pulse wave ampule) using a&#xD;
      waveform with peripheral oxygen saturation. Through this process, patients want to objectify&#xD;
      the amount of anesthetic agent used during surgery. And all patients are inserted the&#xD;
      laryngeal mask airway.&#xD;
&#xD;
      This study would try find out whether persistent pain after mastectomy is affected anesthetic&#xD;
      factors appropriate anesthesia depth and opioid using standardized monitoring devices limited&#xD;
      to similar surgical ranges.&#xD;
&#xD;
      The investigators hypothesize that patients who suffered severe acute postoperative pain,&#xD;
      regardless of their anesthesia method, have a higher incidence of persistent post-mastectomy&#xD;
      pain.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 31, 2018</start_date>
  <completion_date type="Actual">December 30, 2019</completion_date>
  <primary_completion_date type="Actual">December 5, 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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>persistent pain</measure>
    <time_frame>postoperative 2 months</time_frame>
    <description>persistent postoperative pain after mastectomy (Numeric rating pain score (NSR: no pain=1, worst pain=10)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>acute postoperative pain</measure>
    <time_frame>postoperative 1 hour</time_frame>
    <description>acute postoperative pain in the recovery room measured by Numeric rating pain score (NSR: no pain=1, worst pain=10)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>inhalation agent</measure>
    <time_frame>intraoperative</time_frame>
    <description>inhalation anesthetics use or total intravenous anesthesia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>opioid consumption</measure>
    <time_frame>intraoperative</time_frame>
    <description>the amount of opioid</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>surgical anxiety level</measure>
    <time_frame>1 day before surgery</time_frame>
    <description>(0: not anxiety-100: extremely anxious)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>anticipate pain</measure>
    <time_frame>1 day before surgery</time_frame>
    <description>(0: no pain-100: a bad as you can imagine)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>anticipated pain medication need</measure>
    <time_frame>1 day before surgery</time_frame>
    <description>(0: none at all, 1: much less than average, 2: less than average, 3: average, 4: more than average, 5: much more than average)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>surgery factor</measure>
    <time_frame>intraoperative</time_frame>
    <description>the incision size and the number of excision of lymph node</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The surgical pleth index</measure>
    <time_frame>intraoperative</time_frame>
    <description>the highest surgical pleth index score in time of start anesthesia and ene of anesthesia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The pain score of discharge</measure>
    <time_frame>on the 1 day of discharge</time_frame>
    <description>Numeric rating pain score (NSR: no pain=1, worst pain=10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the consumption of postoperative analgesia</measure>
    <time_frame>postoperative 72 hours</time_frame>
    <description>the consumption of postoperative analgesia during in-hospital day</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">89</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Chronic Post-Procedural Pain</condition>
  <arm_group>
    <arm_group_label>mastectomy group</arm_group_label>
    <description>All patients who received the mastectomy (breast conserving surgery and sentinel lymph node dissection)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>acute postoperative pain</intervention_name>
    <description>All patients assessed postoperative pain score in the recovery room and postoperative 2 month</description>
    <arm_group_label>mastectomy group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        the 20-70 year old patients who undergoing breast conserving surgery + sentinel lymph node&#xD;
        dissection at samsung medical center&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -undergoing breast conserving surgery + sentinel lymph node dissection&#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;
&#xD;
          -  performing axillary lymph node dissection or Total mastectomy&#xD;
&#xD;
          -  difficult airway and failed to place laryngeal mask airway properly&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <state>Gangnam-gu</state>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <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>Cui L, Fan P, Qiu C, Hong Y. Single institution analysis of incidence and risk factors for post-mastectomy pain syndrome. Sci Rep. 2018 Jul 31;8(1):11494. doi: 10.1038/s41598-018-29946-x.</citation>
    <PMID>30065342</PMID>
  </reference>
  <reference>
    <citation>Gartner R, Jensen MB, Nielsen J, Ewertz M, Kroman N, Kehlet H. Prevalence of and factors associated with persistent pain following breast cancer surgery. JAMA. 2009 Nov 11;302(18):1985-92. doi: 10.1001/jama.2009.1568. Erratum In: JAMA. 2012 Nov 21;308(19):1973.</citation>
    <PMID>19903919</PMID>
  </reference>
  <reference>
    <citation>Pan PH, Tonidandel AM, Aschenbrenner CA, Houle TT, Harris LC, Eisenach JC. Predicting acute pain after cesarean delivery using three simple questions. Anesthesiology. 2013 May;118(5):1170-9. doi: 10.1097/ALN.0b013e31828e156f.</citation>
    <PMID>23485992</PMID>
  </reference>
  <reference>
    <citation>Lefebvre-Kuntz D, Duale C, Albi-Feldzer A, Nougarede B, Falewee MN, Ouchchane L, Soule-Sonneville S, Bonneau J, Dubray C, Schoeffler P. General anaesthetic agents do not influence persistent pain after breast cancer surgery: A prospective nationwide cohort study. Eur J Anaesthesiol. 2015 Oct;32(10):697-704. doi: 10.1097/EJA.0000000000000215.</citation>
    <PMID>26053994</PMID>
  </reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>January 30, 2020</last_update_submitted>
  <last_update_submitted_qc>January 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2020</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>Breast Neoplasms</mesh_term>
    <mesh_term>Pain, Procedural</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03782896
org study id: SMC2018-09-029-003
nct id: NCT03782896
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Persistent postoperative pain occurs up to 25 to 60 % after mastectomy. This occurs at a
      higher frequency than the rate of invasive surgery.Therefore, many ways have been tried to
      study risk factors. A study was conducted to predict postoperative pain for items
      (preoperative pain, sensitivity, pain prediction). As a result, it was reported that the
      scope of surgery, pre-operative pain, young age, and depression were associated with
      persistent pain.

      This study try to find out whether persistent pain after mastectomy is affected anesthetic
      factors appropriate anesthesia depth and opioid using standardized monitoring devices limited
      to similar surgical ranges.
Persistent postoperative pain occurs up to 25 to 60 % after mastectomy. This occurs at a
      higher frequency than the rate of invasive surgery.Therefore, many ways have been tried to
      study risk factors. A study was conducted to predict postoperative pain for items
      (preoperative pain, sensitivity, pain prediction). As a result, it was reported that the
      scope of surgery, pre-operative pain, young age, and depression were associated with
      persistent pain.

      There were reports of no association with anesthesia in the area of anesthesia to the high
      pain control requirement in the postoperative recovery room, 24 hours of high pain
      medication, use of inhalation agent, and a high dosage of remifentanil. However, an
      anesthesia-related study was either a retrospective study or anesthetic was injected with
      more than a clinical dose in order to make the difference following methods.

      In this study, bispectral index is used to maintain anesthesia depth. In addition, the
      commercially available noninvasive pain depth equipment (Surgical Pleth Index) is used to
      assess the nociception-antinociception balance. Displays the automatically calculated values
      of SPI=100-(0.3*heartbeat interval + 0.7*photoplethysmographic pulse wave ampule) using a
      waveform with peripheral oxygen saturation. Through this process, patients want to objectify
      the amount of anesthetic agent used during surgery. And all patients are inserted the
      laryngeal mask airway.

      This study would try find out whether persistent pain after mastectomy is affected anesthetic
      factors appropriate anesthesia depth and opioid using standardized monitoring devices limited
      to similar surgical ranges.

      The investigators hypothesize that patients who suffered severe acute postoperative pain,
      regardless of their anesthesia method, have a higher incidence of persistent post-mastectomy
      pain.
observational model: Case-Only
time perspective: Cross-Sectional
measure: persistent pain
time frame: postoperative 2 months
description: persistent postoperative pain after mastectomy (Numeric rating pain score (NSR: no pain=1, worst pain=10)
measure: acute postoperative pain
time frame: postoperative 1 hour
description: acute postoperative pain in the recovery room measured by Numeric rating pain score (NSR: no pain=1, worst pain=10)
measure: inhalation agent
time frame: intraoperative
description: inhalation anesthetics use or total intravenous anesthesia
measure: opioid consumption
time frame: intraoperative
description: the amount of opioid
measure: surgical anxiety level
time frame: 1 day before surgery
description: (0: not anxiety-100: extremely anxious)
measure: anticipate pain
time frame: 1 day before surgery
description: (0: no pain-100: a bad as you can imagine)
measure: anticipated pain medication need
time frame: 1 day before surgery
description: (0: none at all, 1: much less than average, 2: less than average, 3: average, 4: more than average, 5: much more than average)
measure: surgery factor
time frame: intraoperative
description: the incision size and the number of excision of lymph node
measure: The surgical pleth index
time frame: intraoperative
description: the highest surgical pleth index score in time of start anesthesia and ene of anesthesia
measure: The pain score of discharge
time frame: on the 1 day of discharge
description: Numeric rating pain score (NSR: no pain=1, worst pain=10)
measure: the consumption of postoperative analgesia
time frame: postoperative 72 hours
description: the consumption of postoperative analgesia during in-hospital day
arm group label: mastectomy group
description: All patients who received the mastectomy (breast conserving surgery and sentinel lymph node dissection)
intervention type: Other
intervention name: acute postoperative pain
description: All patients assessed postoperative pain score in the recovery room and postoperative 2 month
arm group label: mastectomy group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
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: Cui L, Fan P, Qiu C, Hong Y. Single institution analysis of incidence and risk factors for post-mastectomy pain syndrome. Sci Rep. 2018 Jul 31;8(1):11494. doi: 10.1038/s41598-018-29946-x.
PMID: 30065342
citation: Gartner R, Jensen MB, Nielsen J, Ewertz M, Kroman N, Kehlet H. Prevalence of and factors associated with persistent pain following breast cancer surgery. JAMA. 2009 Nov 11;302(18):1985-92. doi: 10.1001/jama.2009.1568. Erratum In: JAMA. 2012 Nov 21;308(19):1973.
PMID: 19903919
citation: Pan PH, Tonidandel AM, Aschenbrenner CA, Houle TT, Harris LC, Eisenach JC. Predicting acute pain after cesarean delivery using three simple questions. Anesthesiology. 2013 May;118(5):1170-9. doi: 10.1097/ALN.0b013e31828e156f.
PMID: 23485992
citation: Lefebvre-Kuntz D, Duale C, Albi-Feldzer A, Nougarede B, Falewee MN, Ouchchane L, Soule-Sonneville S, Bonneau J, Dubray C, Schoeffler P. General anaesthetic agents do not influence persistent pain after breast cancer surgery: A prospective nationwide cohort study. Eur J Anaesthesiol. 2015 Oct;32(10):697-704. doi: 10.1097/EJA.0000000000000215.
PMID: 26053994
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Pain, Procedural
sharing ipd: Undecided