<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/NCT01693588</url>
  </required_header>
  <id_info>
    <org_study_id>341-2012</org_study_id>
    <nct_id>NCT01693588</nct_id>
  </id_info>
  <brief_title>Study of a Multimodality Pain Management Protocol on Postoperative Neurosurgical Pain</brief_title>
  <official_title>The Effect of a Multimodality Pain Management Protocol on Postoperative Neurosurgical Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Florida</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      High levels of postoperative pain are associated with an increased risk of lung and heart&#xD;
      complications, are the most common reason for delayed discharge or for unexpected hospital&#xD;
      admission after ambulatory surgery, and are responsible for prolonged recovery after&#xD;
      inpatient surgery. Furthermore both neuropathic pain and post surgical pain inhibit weight&#xD;
      gain and may have an impact on the patient's nutrition post operatively. The purpose of this&#xD;
      study is to evaluate the effectiveness of a multimodality pain management protocol on&#xD;
      postoperative neurosurgical pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Despite the long-standing recognition of postoperative pain as both prevalent and&#xD;
      undertreated, 20% to 30% of all surgical patients continue to experience moderate to severe&#xD;
      postoperative pain. High levels of postoperative pain are associated with an increased risk&#xD;
      of pulmonary and cardiovascular complications, are the most common reason for delayed&#xD;
      discharge or for unexpected hospital admission after ambulatory surgery, and are responsible&#xD;
      for prolonged convalescence after inpatient surgery. Furthermore both neuropathic pain and&#xD;
      post surgical pain inhibit weight gain and may have an impact on the patient's nutrition post&#xD;
      operatively. Finally, high levels of postoperative pain have also been associated with an&#xD;
      increased risk of chronic pain. Therefore, the aggressive treatment of postoperative pain may&#xD;
      be particularly important in influencing patient outcomes, inadvertent readmissions, and&#xD;
      propensity for developing chronic pain.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">August 2013</completion_date>
  <primary_completion_date type="Actual">August 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Score on the Visual Analogue Scale</measure>
    <time_frame>Post Operative Day 1</time_frame>
    <description>The Visual Analogue Scale measures the severity of pain on a continuous scale from 0 (no pain) to 10 (worst possible pain).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Score on the Visual Analogue Scale</measure>
    <time_frame>Post Operative Day 3</time_frame>
    <description>The Visual Analogue Scale measures the severity of pain on a continuous scale from 0 (no pain) to 10 (worst possible pain).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Score on the HCAHP survey.</measure>
    <time_frame>Hospital discharge, an expected average of 5 days.</time_frame>
    <description>The HCAHP survey measures how often patients perceived an aspect of their care was performed, generally using a scale of always, usually, sometimes, and never.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">94</enrollment>
  <condition>Pain</condition>
  <condition>Postoperative Pain</condition>
  <condition>Surgical Pain</condition>
  <condition>Neurosurgical Pain</condition>
  <arm_group>
    <arm_group_label>Pain Management Bundle</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Pain Management Bundle will be implemented for all postoperative neurosurgical patients admitted to nursing units at the University of Florida.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pain Management Bundle</intervention_name>
    <description>The Pain Management Bundle will be implemented for all postoperative neurosurgical patients admitted to nursing units at the University of Florida.</description>
    <arm_group_label>Pain Management Bundle</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Postoperative neurosurgical patient treated at the University of Florida&#xD;
&#xD;
          -  Primary language is English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Younger than 18 or older than 100 years of age&#xD;
&#xD;
          -  Patients who are pregnant, wards of the state, prisoners, and patients who lack the&#xD;
             ability to communicate their pain level&#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>William L. Titsworth, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2014</verification_date>
  <study_first_submitted>September 14, 2012</study_first_submitted>
  <study_first_submitted_qc>September 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <last_update_submitted>January 13, 2014</last_update_submitted>
  <last_update_submitted_qc>January 13, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 14, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pain</keyword>
  <keyword>Postoperative Pain</keyword>
  <keyword>Surgical Pain</keyword>
  <keyword>Neurosurgical Pain</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/NCT01693588
org study id: 341-2012
nct id: NCT01693588
lead sponsor: 
has dmc: No
High levels of postoperative pain are associated with an increased risk of lung and heart
      complications, are the most common reason for delayed discharge or for unexpected hospital
      admission after ambulatory surgery, and are responsible for prolonged recovery after
      inpatient surgery. Furthermore both neuropathic pain and post surgical pain inhibit weight
      gain and may have an impact on the patient's nutrition post operatively. The purpose of this
      study is to evaluate the effectiveness of a multimodality pain management protocol on
      postoperative neurosurgical pain.
Despite the long-standing recognition of postoperative pain as both prevalent and
      undertreated, 20% to 30% of all surgical patients continue to experience moderate to severe
      postoperative pain. High levels of postoperative pain are associated with an increased risk
      of pulmonary and cardiovascular complications, are the most common reason for delayed
      discharge or for unexpected hospital admission after ambulatory surgery, and are responsible
      for prolonged convalescence after inpatient surgery. Furthermore both neuropathic pain and
      post surgical pain inhibit weight gain and may have an impact on the patient's nutrition post
      operatively. Finally, high levels of postoperative pain have also been associated with an
      increased risk of chronic pain. Therefore, the aggressive treatment of postoperative pain may
      be particularly important in influencing patient outcomes, inadvertent readmissions, and
      propensity for developing chronic pain.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Mean Score on the Visual Analogue Scale
time frame: Post Operative Day 1
description: The Visual Analogue Scale measures the severity of pain on a continuous scale from 0 (no pain) to 10 (worst possible pain).
measure: Mean Score on the Visual Analogue Scale
time frame: Post Operative Day 3
description: The Visual Analogue Scale measures the severity of pain on a continuous scale from 0 (no pain) to 10 (worst possible pain).
measure: Score on the HCAHP survey.
time frame: Hospital discharge, an expected average of 5 days.
description: The HCAHP survey measures how often patients perceived an aspect of their care was performed, generally using a scale of always, usually, sometimes, and never.
arm group label: Pain Management Bundle
arm group type: Experimental
description: The Pain Management Bundle will be implemented for all postoperative neurosurgical patients admitted to nursing units at the University of Florida.
intervention type: Other
intervention name: Pain Management Bundle
description: The Pain Management Bundle will be implemented for all postoperative neurosurgical patients admitted to nursing units at the University of Florida.
arm group label: Pain Management Bundle
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: William L. Titsworth, MD, PhD
role: Principal Investigator
affiliation: University of Florida
facility: 
country: United States
responsible party type: Sponsor
mesh term: Pain, Postoperative