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/NCT06023225</url>
    </required_header>
    <id_info>
      <org_study_id>202210083</org_study_id>
      <nct_id>NCT06023225</nct_id>
    </id_info>
    <brief_title>Sex Hormones, Postoperative Pain and Opioid Use</brief_title>
    <acronym>SPO</acronym>
    <official_title>Relationship Between Sex Hormones, Postoperative Pain and Opioid Use: the Role of Immune Factors</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Washington University School of Medicine</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Washington University School of Medicine</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Aim 1- To identify relationships between sex hormone levels and postoperative pain and opioid&#xD;
        use.&#xD;
  &#xD;
        Aim 2: To determine whether the effects of testosterone on postoperative pain and opioid use&#xD;
        are mediated by immune factors&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        After signing the consent and assent forms, participants and their parents/guardians will&#xD;
        complete several surveys, including demographic, behavioral, pain, substance use and&#xD;
        analgesic risk assessment measures, and developmental surveys. In addition, a blood sample&#xD;
        (for hormonal and immune analyses) will be collected on the day of the surgery and/or&#xD;
        postoperative. Surgery-related parameters including postoperative pain, and opioid type and&#xD;
        doses during the hospital time will be collected.&#xD;
  &#xD;
        In addition, before or after the surgery, patients and their parents/guardians will be&#xD;
        interviewed. The interview will include questions about the surgery and about potential&#xD;
        future study assessing the efficacy of sex hormone treatment on opioid use.&#xD;
  &#xD;
        Longitudinal measures. At routine follow-up with the surgeons or after 1 week, 1 month, 3&#xD;
        months, and 6 months, study staff will contact patients to inquire about persistent pain&#xD;
        (location, severity), and persistent opioid use. Based on previous studies, we estimate that&#xD;
        ∼30% will have persistent postoperative pain, and ∼5% will have persistent opioid use.After&#xD;
        signing the consent and assent forms, participants and their parents/guardians will complete&#xD;
        several surveys, including demographic, behavioral, pain, substance use and analgesic risk&#xD;
        assessment measures, and developmental surveys. In addition, a blood sample (for hormonal and&#xD;
        immune analyses) will be collected on the day of the surgery and/or postoperative.&#xD;
        Surgery-related parameters including postoperative pain, and opioid type and doses during the&#xD;
        hospital time will be collected.&#xD;
  &#xD;
        In addition, before or after the surgery, patients and their parents/guardians will be&#xD;
        interviewed. The interview will include questions about the surgery and about potential&#xD;
        future study assessing the efficacy of sex hormone treatment on opioid use.&#xD;
  &#xD;
        Longitudinal measures. At routine follow-up with the surgeons or after 1 week, 1 month, 3&#xD;
        months, and 6 months, study staff will contact patients to inquire about persistent pain&#xD;
        (location, severity), and persistent opioid use. Based on previous studies, we estimate that&#xD;
        ∼30% will have persistent postoperative pain, and ∼5% will have persistent opioid use.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">July 1, 2027</completion_date>
    <primary_completion_date type="Anticipated">July 1, 2025</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>Sex hormone level of Testosterone</measure>
      <time_frame>Baseline</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Sex hormone level of estrogen</measure>
      <time_frame>Baseline</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Sex hormone level of progesterone</measure>
      <time_frame>Baseline</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Levels of IL-10 and IL-6</measure>
      <time_frame>Baseline</time_frame>
      <description>Immune factors</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">210</enrollment>
    <condition>Postoperative Pain</condition>
    <condition>Opioid Use</condition>
    <arm_group>
      <arm_group_label>Postoperative patients</arm_group_label>
      <description>Pediatric female patients undergoing a surgical procedure</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Pain</intervention_name>
      <description>Postoperative pain levels</description>
      <arm_group_label>Postoperative patients</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Opioid use</intervention_name>
      <description>Postoperative opioid use</description>
      <arm_group_label>Postoperative patients</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Pediatric female patients between the ages 11-16 undergoing an orthopedic surgical&#xD;
          procedure&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Pediatric female patients between the ages 11-16 undergoing an orthopedic (trauma and&#xD;
          non-trauma) surgical procedure involving a long bone or joint, or the spine, English&#xD;
          speaking&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Pregnancy; Diagnosis of chronic pain, Psychiatric, developmental or neurological disorders,&#xD;
          Disorders that are associated with pubertal maturation (e.g., precocious puberty).&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>11 Years</minimum_age>
      <maximum_age>16 Years</maximum_age>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Washington University School of Medicine</investigator_affiliation>
      <investigator_full_name>Hadas Nahman-Averbuch</investigator_full_name>
      <investigator_title>Asst Prof of Anesthesiology</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pain, Postoperative</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Analgesics, Opioid</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT06023225
  org study id: 202210083
  nct id: NCT06023225
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Aim 1- To identify relationships between sex hormone levels and postoperative pain and opioid
        use.
  
        Aim 2: To determine whether the effects of testosterone on postoperative pain and opioid use
        are mediated by immune factors
  After signing the consent and assent forms, participants and their parents/guardians will
        complete several surveys, including demographic, behavioral, pain, substance use and
        analgesic risk assessment measures, and developmental surveys. In addition, a blood sample
        (for hormonal and immune analyses) will be collected on the day of the surgery and/or
        postoperative. Surgery-related parameters including postoperative pain, and opioid type and
        doses during the hospital time will be collected.
  
        In addition, before or after the surgery, patients and their parents/guardians will be
        interviewed. The interview will include questions about the surgery and about potential
        future study assessing the efficacy of sex hormone treatment on opioid use.
  
        Longitudinal measures. At routine follow-up with the surgeons or after 1 week, 1 month, 3
        months, and 6 months, study staff will contact patients to inquire about persistent pain
        (location, severity), and persistent opioid use. Based on previous studies, we estimate that
        ∼30% will have persistent postoperative pain, and ∼5% will have persistent opioid use.After
        signing the consent and assent forms, participants and their parents/guardians will complete
        several surveys, including demographic, behavioral, pain, substance use and analgesic risk
        assessment measures, and developmental surveys. In addition, a blood sample (for hormonal and
        immune analyses) will be collected on the day of the surgery and/or postoperative.
        Surgery-related parameters including postoperative pain, and opioid type and doses during the
        hospital time will be collected.
  
        In addition, before or after the surgery, patients and their parents/guardians will be
        interviewed. The interview will include questions about the surgery and about potential
        future study assessing the efficacy of sex hormone treatment on opioid use.
  
        Longitudinal measures. At routine follow-up with the surgeons or after 1 week, 1 month, 3
        months, and 6 months, study staff will contact patients to inquire about persistent pain
        (location, severity), and persistent opioid use. Based on previous studies, we estimate that
        ∼30% will have persistent postoperative pain, and ∼5% will have persistent opioid use.
  observational model: Case-Only
  time perspective: Prospective
  measure: Sex hormone level of Testosterone
  time frame: Baseline
  measure: Sex hormone level of estrogen
  time frame: Baseline
  measure: Sex hormone level of progesterone
  time frame: Baseline
  measure: Levels of IL-10 and IL-6
  time frame: Baseline
  description: Immune factors
  arm group label: Postoperative patients
  description: Pediatric female patients undergoing a surgical procedure
  intervention type: Behavioral
  intervention name: Pain
  description: Postoperative pain levels
  arm group label: Postoperative patients
  intervention type: Behavioral
  intervention name: Opioid use
  description: Postoperative opioid use
  arm group label: Postoperative patients
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: Female
  minimum age: 11 Years
  maximum age: 16 Years
  responsible party type: Principal Investigator
  investigator affiliation: Washington University School of Medicine
  investigator full name: Hadas Nahman-Averbuch
  investigator title: Asst Prof of Anesthesiology
  mesh term: Pain, Postoperative
  mesh term: Analgesics, Opioid
  sharing ipd: No