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/NCT06039566</url>
    </required_header>
    <id_info>
      <org_study_id>Pro00130489</org_study_id>
      <nct_id>NCT06039566</nct_id>
    </id_info>
    <brief_title>NAC vs Placebo on Opioid Use for Hysterectomy</brief_title>
    <official_title>A Trial Evaluating the Impact of N-acetylcysteine on Opioid Use in Patients Undergoing a Hysterectomy Procedure</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Medical University of South Carolina</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Medical University of South Carolina</source>
    <oversight_info>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study will enroll females who are ages 18 and older undergoing a laparoscopic or&#xD;
        robotic, partial or full hysterectomy. Participants will be randomized to receive IV&#xD;
        n-acetylcysteine or placebo during the first 60 minutes of their procedure. At various time&#xD;
        points after the procedure patients will be asked to report their pain scores, and any pain&#xD;
        medication taken.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 25, 2023</start_date>
    <completion_date type="Anticipated">October 9, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 25, 2025</primary_completion_date>
    <phase>Phase 3</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>Opioid Consumption 0-72 hours post-study medication</measure>
      <time_frame>0-72 hours after study medication</time_frame>
      <description>72-hour post-medication opioid consumption.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Pain Scores</measure>
      <time_frame>Study medication start to 72 hours post-study medication</time_frame>
      <description>Using a Visual Analog Scale from 0-100, patients will report pain scores from 0-72 hours post-medication. A lower pain score means a better outcome.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>intraoperative opioid consumption</measure>
      <time_frame>during the procedure (up to 12 hours)</time_frame>
      <description>Total morphine milligram equivalents administered during the procedure</description>
    </other_outcome>
    <other_outcome>
      <measure>postoperative anesthesia care unit (PACU) opioid consumption</measure>
      <time_frame>PACU Arrival until PACU Discharge up to 52 weeks</time_frame>
      <description>Total morphine milligram equivalents administered in the PACU</description>
    </other_outcome>
    <other_outcome>
      <measure>non-opioid analgesic administration</measure>
      <time_frame>Anesthesia start until PACU discharge up to 52 weeks</time_frame>
      <description>Total other pain medication administered during the procedure and in PACU</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">240</enrollment>
    <condition>Hysterectomy</condition>
    <arm_group>
      <arm_group_label>IV Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Patients will receive: Placebo 0 mg/kg (placebo: 0.45% NaCl or D5W) through an IV that will run for 60 minutes at the start of the procedure.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>IV N-acetylcysteine</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients will receive: N-acetylcysteine (NAC) 150 mg/kg (Max dose 15,000 mg) through an IV that will run for 60 minutes at the start of the procedure.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>IV N-acetylcysteine</intervention_name>
      <description>N-acetylcysteine (NAC) 150 mg/kg (Max dose 15,000 mg) through an IV that will run for 60 minutes at the start of the procedure</description>
      <arm_group_label>IV N-acetylcysteine</arm_group_label>
      <other_name>NAC</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>IV Placebo</intervention_name>
      <description>Placebo 0 mg/kg (placebo: 0.45% NaCl or D5W) through an IV that will run for 60 minutes at the start of the procedure.</description>
      <arm_group_label>IV Placebo</arm_group_label>
      <other_name>Placebo</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion&#xD;
  &#xD;
            -  Undergoing elective laparoscopic or robotic, full, or partial hysterectomy procedure&#xD;
  &#xD;
            -  18 years of age and older&#xD;
  &#xD;
          Exclusion&#xD;
  &#xD;
            -  Less than 40kg in weight&#xD;
  &#xD;
            -  Unable to provide written, informed consent&#xD;
  &#xD;
            -  History of an adverse or anaphylactoid reaction to acetylcysteine&#xD;
  &#xD;
            -  Active asthma, wheezing, or using inhaled bronchodilators&#xD;
  &#xD;
            -  Non-English speaking&#xD;
  &#xD;
            -  Insulin dependent diabetes if D5W is required&#xD;
  &#xD;
            -  Blood clotting disorders&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Female</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Sylvia Wilson, M.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Medical University of South Carolina</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Haley Nitchie, MHA</last_name>
      <phone>843-792-1869</phone>
      <email>nitchie@musc.edu</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 25, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Medical University of South Carolina</investigator_affiliation>
      <investigator_full_name>Sylvia Wilson</investigator_full_name>
      <investigator_title>Professor of Anesthesiology</investigator_title>
    </responsible_party>
    <keyword>hysterectomy</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Acetylcysteine</mesh_term>
      <mesh_term>N-monoacetylcystine</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/NCT06039566
  org study id: Pro00130489
  nct id: NCT06039566
  lead sponsor: 
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  This study will enroll females who are ages 18 and older undergoing a laparoscopic or
        robotic, partial or full hysterectomy. Participants will be randomized to receive IV
        n-acetylcysteine or placebo during the first 60 minutes of their procedure. At various time
        points after the procedure patients will be asked to report their pain scores, and any pain
        medication taken.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: Opioid Consumption 0-72 hours post-study medication
  time frame: 0-72 hours after study medication
  description: 72-hour post-medication opioid consumption.
  measure: Pain Scores
  time frame: Study medication start to 72 hours post-study medication
  description: Using a Visual Analog Scale from 0-100, patients will report pain scores from 0-72 hours post-medication. A lower pain score means a better outcome.
  measure: intraoperative opioid consumption
  time frame: during the procedure (up to 12 hours)
  description: Total morphine milligram equivalents administered during the procedure
  measure: postoperative anesthesia care unit (PACU) opioid consumption
  time frame: PACU Arrival until PACU Discharge up to 52 weeks
  description: Total morphine milligram equivalents administered in the PACU
  measure: non-opioid analgesic administration
  time frame: Anesthesia start until PACU discharge up to 52 weeks
  description: Total other pain medication administered during the procedure and in PACU
  arm group label: IV Placebo
  arm group type: Placebo Comparator
  description: Patients will receive: Placebo 0 mg/kg (placebo: 0.45% NaCl or D5W) through an IV that will run for 60 minutes at the start of the procedure.
  arm group label: IV N-acetylcysteine
  arm group type: Active Comparator
  description: Patients will receive: N-acetylcysteine (NAC) 150 mg/kg (Max dose 15,000 mg) through an IV that will run for 60 minutes at the start of the procedure.
  intervention type: Drug
  intervention name: IV N-acetylcysteine
  description: N-acetylcysteine (NAC) 150 mg/kg (Max dose 15,000 mg) through an IV that will run for 60 minutes at the start of the procedure
  arm group label: IV N-acetylcysteine
  other name: NAC
  intervention type: Drug
  intervention name: IV Placebo
  description: Placebo 0 mg/kg (placebo: 0.45% NaCl or D5W) through an IV that will run for 60 minutes at the start of the procedure.
  arm group label: IV Placebo
  other name: Placebo
  criteria: 
  gender: All
  gender based: Yes
  gender description: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Sylvia Wilson, M.D.
  role: Principal Investigator
  affiliation: Medical University of South Carolina
  last name: Haley Nitchie, MHA
  phone: 843-792-1869
  email: nitchie@musc.edu
  responsible party type: Principal Investigator
  investigator affiliation: Medical University of South Carolina
  investigator full name: Sylvia Wilson
  investigator title: Professor of Anesthesiology
  mesh term: Acetylcysteine
  mesh term: N-monoacetylcystine
  sharing ipd: No