<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/NCT03261310</url>
  </required_header>
  <id_info>
    <org_study_id>386486-1</org_study_id>
    <nct_id>NCT03261310</nct_id>
  </id_info>
  <brief_title>Use of IV Acetaminophen in the Treatment of Post Operative Pain in Patients Undergoing Craniotomy and Spine Surgery</brief_title>
  <official_title>Use of IV Acetaminophen in the Treatment of Post Operative Pain in Patients Undergoing Craniotomy and Spine Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brooke Army Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Brooke Army Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the effectiveness of intravenous acetaminophen&#xD;
      (Tylenol) for post operative pain control in patients undergoing craniotomies (brain surgery)&#xD;
      and spine surgery. Studies have shown that intravenous acetaminophen is useful for post&#xD;
      operative pain control in some operations but there have not been studies to evaluate the use&#xD;
      of acetaminophen in craniotomies or spine surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to investigate the effectiveness of intravenous acetaminophen&#xD;
      (Tylenol) for post operative pain control in patients undergoing craniotomies (brain surgery)&#xD;
      and spine surgery. Studies have shown that intravenous acetaminophen is useful for post&#xD;
      operative pain control in some operations but there have not been studies to evaluate the use&#xD;
      of acetaminophen in craniotomies or spine surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>May 2013</start_date>
  <completion_date type="Anticipated">July 2018</completion_date>
  <primary_completion_date type="Anticipated">July 2018</primary_completion_date>
  <phase>N/A</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, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain Scores</measure>
    <time_frame>1hour -6 hours</time_frame>
    <description>Primary outcomes will be measured pain scores at post-operative timepoints (1, 2, 4 and 6 hours), and the calculated percent change from baseline (1 hr post-op) for each of the follow-up pain scores (2, 4, 6 hours).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Opioid administration</measure>
    <time_frame>1 hour-6 hours</time_frame>
    <description>Secondary outcome will be a comparison of morphine equivalent dosages of opioid administered during the same periods between the treatment and control groups.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">55</enrollment>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>Acetaminophen &amp; Craniotomy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug: Acetaminophen 1000mg administered intravenously during craniotomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo &amp; Craniotomy</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo administered intravenously during craniotomy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Acetaminophen &amp; Laminectomy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Acetaminophen 1000mg administered intravenously during laminectomy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo &amp; Laminectomy</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo administered during laminectomy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Acetaminophen or Placebo</intervention_name>
    <description>Study subject will receive either 1000mg of acetaminophen in 100ml own diluent, or 100ml of saline during their intra-operative period and an order will be placed in their chart/Essentris order for &quot;No acetaminophen for 6 hours post operatively&quot;.</description>
    <arm_group_label>Acetaminophen &amp; Craniotomy</arm_group_label>
    <arm_group_label>Acetaminophen &amp; Laminectomy</arm_group_label>
    <arm_group_label>Placebo &amp; Craniotomy</arm_group_label>
    <arm_group_label>Placebo &amp; Laminectomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-90 years old&#xD;
&#xD;
          -  undergoing non-emergent craniotomy or single level lumbar laminectomy&#xD;
&#xD;
          -  must be able to rate pain on a 0-10 scale post-operatively&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of liver disease&#xD;
&#xD;
          -  allergy to acetaminophen&#xD;
&#xD;
          -  age less than 18 years&#xD;
&#xD;
          -  renal failure with creatinine clearance less than 30&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  altered mentation with inability to report pain score&#xD;
&#xD;
          -  patients who have received acetaminophen within 6 hours of surgery&#xD;
&#xD;
          -  patients in which a neuraxial technique has been performed for surgery&#xD;
&#xD;
          -  prisoners&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dimitar Dentchev, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>BAMC</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Betsy Murray, MD</last_name>
    <role>Study Chair</role>
    <affiliation>BAMC</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Robert Vietor, MD</last_name>
    <role>Study Chair</role>
    <affiliation>BAMC</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jonathan Deeth, MD</last_name>
    <role>Study Chair</role>
    <affiliation>BAMC</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Daniel Stypula, DO</last_name>
    <role>Study Chair</role>
    <affiliation>BAMC</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dimitar Dentchev, MD</last_name>
    <phone>210-916-2118</phone>
    <email>dimitar.i.dentchev.civ@mail.mil</email>
  </overall_contact>
  <location>
    <facility>
      <name>Brooke Army Medical Center</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78234</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dimitar Dentchev, MD</last_name>
      <phone>210-916-2118</phone>
      <email>dimitar.i.dentchev.civ@mail.mil</email>
    </contact>
    <investigator>
      <last_name>Dimitar Dentchev, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>April 23, 2014</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>August 23, 2017</last_update_submitted>
  <last_update_submitted_qc>August 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brooke Army Medical Center</investigator_affiliation>
    <investigator_full_name>Dimitar Dentchev</investigator_full_name>
    <investigator_title>Staff Anesthesiologist</investigator_title>
  </responsible_party>
  <keyword>acetaminophen</keyword>
  <keyword>pain</keyword>
  <keyword>laminectomy</keyword>
  <keyword>craniotomy</keyword>
  <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>Acetaminophen</mesh_term>
  </intervention_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/NCT03261310
org study id: 386486-1
nct id: NCT03261310
lead sponsor: 
has dmc: Yes
The purpose of this study is to investigate the effectiveness of intravenous acetaminophen
      (Tylenol) for post operative pain control in patients undergoing craniotomies (brain surgery)
      and spine surgery. Studies have shown that intravenous acetaminophen is useful for post
      operative pain control in some operations but there have not been studies to evaluate the use
      of acetaminophen in craniotomies or spine surgery.
The purpose of this study is to investigate the effectiveness of intravenous acetaminophen
      (Tylenol) for post operative pain control in patients undergoing craniotomies (brain surgery)
      and spine surgery. Studies have shown that intravenous acetaminophen is useful for post
      operative pain control in some operations but there have not been studies to evaluate the use
      of acetaminophen in craniotomies or spine surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Pain Scores
time frame: 1hour -6 hours
description: Primary outcomes will be measured pain scores at post-operative timepoints (1, 2, 4 and 6 hours), and the calculated percent change from baseline (1 hr post-op) for each of the follow-up pain scores (2, 4, 6 hours).
measure: Opioid administration
time frame: 1 hour-6 hours
description: Secondary outcome will be a comparison of morphine equivalent dosages of opioid administered during the same periods between the treatment and control groups.
arm group label: Acetaminophen & Craniotomy
arm group type: Experimental
description: Drug: Acetaminophen 1000mg administered intravenously during craniotomy
arm group label: Placebo & Craniotomy
arm group type: Placebo Comparator
description: Placebo administered intravenously during craniotomy.
arm group label: Acetaminophen & Laminectomy
arm group type: Experimental
description: Acetaminophen 1000mg administered intravenously during laminectomy.
arm group label: Placebo & Laminectomy
arm group type: Placebo Comparator
description: Placebo administered during laminectomy.
intervention type: Drug
intervention name: Acetaminophen or Placebo
description: Study subject will receive either 1000mg of acetaminophen in 100ml own diluent, or 100ml of saline during their intra-operative period and an order will be placed in their chart/Essentris order for "No acetaminophen for 6 hours post operatively".
arm group label: Acetaminophen & Craniotomy
arm group label: Acetaminophen & Laminectomy
arm group label: Placebo & Craniotomy
arm group label: Placebo & Laminectomy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dimitar Dentchev, MD
role: Principal Investigator
affiliation: BAMC
last name: Betsy Murray, MD
role: Study Chair
affiliation: BAMC
last name: Robert Vietor, MD
role: Study Chair
affiliation: BAMC
last name: Jonathan Deeth, MD
role: Study Chair
affiliation: BAMC
last name: Daniel Stypula, DO
role: Study Chair
affiliation: BAMC
last name: Dimitar Dentchev, MD
phone: 210-916-2118
email: dimitar.i.dentchev.civ@mail.mil
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Brooke Army Medical Center
investigator full name: Dimitar Dentchev
investigator title: Staff Anesthesiologist
mesh term: Pain, Postoperative
mesh term: Acetaminophen
sharing ipd: Undecided