<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/NCT02216682</url>
  </required_header>
  <id_info>
    <org_study_id>2014P001139</org_study_id>
    <nct_id>NCT02216682</nct_id>
  </id_info>
  <brief_title>Assessing the Efficacy of Intravenous Acetaminophen Versus the Oral Formulation for Perioperative Pain Treatment</brief_title>
  <official_title>Assessing the Efficacy of Intravenous Acetaminophen Versus the Oral Formulation for Perioperative Pain Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To compare oral (PO) to intravenous (IV) acetaminophen with postoperative pain scores, and&#xD;
      consumptions of opiates, among orthopedic surgery patients undergoing total knee replacement&#xD;
      with spinal anesthesia.&#xD;
&#xD;
      Our hypothesis is that IV acetaminophen patients will have improved analgesia, less opioid&#xD;
      consumption, a lower percentage of patients rescuing, or a longer time to first rescue with&#xD;
      IV acetaminophen. The investigators will compare the efficacies of oral and intravenous&#xD;
      acetaminophen for postoperative pain control, and utilization of opiates as rescue agents.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Intravenous acetaminophen has rapid onset and potent analgesic properties. Recent studies&#xD;
      have shown several advantages of using intravenous acetaminophen perioperatively. However,&#xD;
      due to its relatively high cost and limited clinical data concerning its efficacy compared&#xD;
      with other agents, physicians are hesitant to use intravenous acetaminophen in the&#xD;
      perioperative period.&#xD;
&#xD;
      174 adult patients from the orthopedic surgeons undergoing total knee replacement with spinal&#xD;
      anesthesia will be enrolled. The study will be double blind, randomized; placebo controlled&#xD;
      comparing oral and IV acetaminophen to each other and a control (placebo). At the time&#xD;
      patients arrive in the post-anesthesia care unit (PACU), Group 1 will receive IV 1 gram&#xD;
      acetaminophen, and PO placebo; Group 2 will receive PO 1 gram acetaminophen and IV placebo;&#xD;
      Group 3 will receive IV placebo and PO placebo.&#xD;
&#xD;
      The primary outcome that will be assessed is pain scores, which will be recorded by using the&#xD;
      numeric rating scale 1-10 every 15 minutes. Secondary outcomes include time to rescue&#xD;
      analgesia (measured in minutes), time to PACU discharge (measured in minutes), and the total&#xD;
      amount of hydromorphone (PO or IV) consumed within 6 hours postoperatively for adequate&#xD;
      analgesia (total measured in milligrams) will be collected.&#xD;
&#xD;
      The difference in pain scores will be assessed by a chi-square test. A multivariable&#xD;
      regression model will be performed with the clinical and statistically significant variables&#xD;
      to remove confounding.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">October 2015</completion_date>
  <primary_completion_date type="Anticipated">August 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Pain scores assessed and recorded by using the numeric rating scale</measure>
    <time_frame>Participants will be followed for the duration of their inpatient hosptial stay, an expected average of one week.</time_frame>
    <description>The primary outcome that will be assessed is pain scores, which will be recorded by using the numeric rating scale, from 1-10, every 15 minutes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to rescue analgesia</measure>
    <time_frame>Participants will be followed for the duration of their hospital stay, an expected average of one week</time_frame>
    <description>The amount of time after the surgery is completed until a patient receives rescue analgesia will be measured in minutes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to post-anesthesia care unit (PACU) discharge</measure>
    <time_frame>Participants will be followed for the duration of their PACU stay, an expected average of 5 hours.</time_frame>
    <description>The time from arrive in the PACU to discharge will be measured in minutes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opioid Use</measure>
    <time_frame>Participants will be followed for six hours postoperatively.</time_frame>
    <description>The investigators will collect total amount of oral and/ or intravenous hydromorphone that is consumed by for adequate analgesia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative nausea and vomiting</measure>
    <time_frame>Participants will be followed for six hours postoperatively.</time_frame>
    <description>The investigators will collect information on postoperative nausea and vomiting.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">174</enrollment>
  <condition>Postoperative Pain</condition>
  <eligibility>
    <study_pop>
      <textblock>
        174 adult patients from the orthopedic surgeons undergoing total knee replacement with&#xD;
        spinal anesthesia will be enrolled. Patients will be enrolled for the study the morning of&#xD;
        their surgery. Subjects will randomly receive one of the three treatments. The study will&#xD;
        be double blind, randomized; placebo controlled comparing PO and IV acetaminophen to each&#xD;
        other and a control (placebo). At the time patients arrive in the PACU, Group 1 will&#xD;
        receive IV 1 gram acetaminophen, and PO placebo; Group 2 will receive PO 1 gram&#xD;
        acetaminophen and IV placebo; Group 3 will receive IV placebo and PO placebo.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing total knee replacement&#xD;
&#xD;
          -  Successful spinal placement&#xD;
&#xD;
          -  ≥18 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Failed spinal anesthesia&#xD;
&#xD;
          -  Chronic opiate users&#xD;
&#xD;
          -  Liver disease patients&#xD;
&#xD;
          -  Allergy/hypersensitivity to acetaminophen&#xD;
&#xD;
          -  Patients with baseline dementia&#xD;
&#xD;
          -  Patients weighing less than 50kg, history of alcohol dependence, renal impairment,&#xD;
             opiate allergy, and pregnancy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jingping Wang, MD, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jingping Wang, MD, Ph.D.</last_name>
    <phone>6176432729</phone>
    <email>jwang23@partners.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>Jingping Wang, MD, Ph.D.</last_name>
      <phone>617-643-2729</phone>
      <email>jwang23@partners.org</email>
    </contact>
    <investigator>
      <last_name>Jingping Wang, MD, Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 11, 2014</study_first_submitted>
  <study_first_submitted_qc>August 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>August 12, 2014</last_update_submitted>
  <last_update_submitted_qc>August 12, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Jingping Wang, MD, Ph.D.</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Acetaminophen</keyword>
  <keyword>Total knee replacement</keyword>
  <keyword>Numeric rating scale</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <!-- 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/NCT02216682
org study id: 2014P001139
nct id: NCT02216682
lead sponsor: 
has dmc: No
To compare oral (PO) to intravenous (IV) acetaminophen with postoperative pain scores, and
      consumptions of opiates, among orthopedic surgery patients undergoing total knee replacement
      with spinal anesthesia.

      Our hypothesis is that IV acetaminophen patients will have improved analgesia, less opioid
      consumption, a lower percentage of patients rescuing, or a longer time to first rescue with
      IV acetaminophen. The investigators will compare the efficacies of oral and intravenous
      acetaminophen for postoperative pain control, and utilization of opiates as rescue agents.
Intravenous acetaminophen has rapid onset and potent analgesic properties. Recent studies
      have shown several advantages of using intravenous acetaminophen perioperatively. However,
      due to its relatively high cost and limited clinical data concerning its efficacy compared
      with other agents, physicians are hesitant to use intravenous acetaminophen in the
      perioperative period.

      174 adult patients from the orthopedic surgeons undergoing total knee replacement with spinal
      anesthesia will be enrolled. The study will be double blind, randomized; placebo controlled
      comparing oral and IV acetaminophen to each other and a control (placebo). At the time
      patients arrive in the post-anesthesia care unit (PACU), Group 1 will receive IV 1 gram
      acetaminophen, and PO placebo; Group 2 will receive PO 1 gram acetaminophen and IV placebo;
      Group 3 will receive IV placebo and PO placebo.

      The primary outcome that will be assessed is pain scores, which will be recorded by using the
      numeric rating scale 1-10 every 15 minutes. Secondary outcomes include time to rescue
      analgesia (measured in minutes), time to PACU discharge (measured in minutes), and the total
      amount of hydromorphone (PO or IV) consumed within 6 hours postoperatively for adequate
      analgesia (total measured in milligrams) will be collected.

      The difference in pain scores will be assessed by a chi-square test. A multivariable
      regression model will be performed with the clinical and statistically significant variables
      to remove confounding.
observational model: Case-Control
time perspective: Prospective
measure: Pain scores assessed and recorded by using the numeric rating scale
time frame: Participants will be followed for the duration of their inpatient hosptial stay, an expected average of one week.
description: The primary outcome that will be assessed is pain scores, which will be recorded by using the numeric rating scale, from 1-10, every 15 minutes.
measure: Time to rescue analgesia
time frame: Participants will be followed for the duration of their hospital stay, an expected average of one week
description: The amount of time after the surgery is completed until a patient receives rescue analgesia will be measured in minutes.
measure: Time to post-anesthesia care unit (PACU) discharge
time frame: Participants will be followed for the duration of their PACU stay, an expected average of 5 hours.
description: The time from arrive in the PACU to discharge will be measured in minutes.
measure: Opioid Use
time frame: Participants will be followed for six hours postoperatively.
description: The investigators will collect total amount of oral and/ or intravenous hydromorphone that is consumed by for adequate analgesia.
measure: Postoperative nausea and vomiting
time frame: Participants will be followed for six hours postoperatively.
description: The investigators will collect information on postoperative nausea and vomiting.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jingping Wang, MD, Ph.D.
role: Principal Investigator
affiliation: Massachusetts General Hospital
last name: Jingping Wang, MD, Ph.D.
phone: 6176432729
email: jwang23@partners.org
facility: 
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Jingping Wang, MD, Ph.D.
investigator title: Assistant Professor
mesh term: Pain, Postoperative