<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/NCT02255955</url>
  </required_header>
  <id_info>
    <org_study_id>Pstoperative pain</org_study_id>
    <nct_id>NCT02255955</nct_id>
  </id_info>
  <brief_title>Postoperative Analgesia in Laminectomy</brief_title>
  <acronym>(PAL)</acronym>
  <official_title>The Effect of Naproxen Sodium + Codeine, and Paracetamol+ Codeine on Postoperative Laminectomy Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Diskapi Yildirim Beyazit Education and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Diskapi Yildirim Beyazit Education and Research Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Compare the analgesic effects of naproxen sodium codeine, paracetamol codeine and placebo on&#xD;
      postoperative pain and tramadol (Contramal) consumption during the first 24 hour after a&#xD;
      lumbar disk surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Compare the analgesic effects of naproxen sodium codeine paracetamol codeine and placebo on&#xD;
      postoperative pain intensity measured by the visual analogue scale, and evaluated tramadol&#xD;
      consumption and related side effects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">December 2014</completion_date>
  <primary_completion_date type="Anticipated">December 2014</primary_completion_date>
  <phase>Phase 4</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>Contramal consumption</measure>
    <time_frame>Postoperative 24 hour</time_frame>
    <description>To assess contramal consumption</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Side effects</measure>
    <time_frame>postoperative 24 hour</time_frame>
    <description>nausea and vomiting</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain intensity</measure>
    <time_frame>postoperative 24 hour</time_frame>
    <description>To assess postoperative pain intensity by visual analog scale</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">75</enrollment>
  <condition>Postoperative Pain</condition>
  <condition>Postoperative Laminectomy Pain</condition>
  <arm_group>
    <arm_group_label>550 mg naproxen sodium and 30mg codeine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Preoperatively patients received oral naproxen sodium codeine, postop contramal infused by PCA, and postoperative contramal consumption, side effects pain intensity measured by VAS.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>300 mg paracetamol and 30 mg codeine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Preoperatively patients received oral paracetamol codeine, postop contramal infused by PCA, and postoperative contramal consumption, side effects pain intensity measured by VAS.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Preoperatively patients received oral placebo tablet, postop contramal infused by PCA, and postoperative contramal consumption, side effects pain intensity measured by VAS.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>550 mg naproxen sodium and 30mg codeine</intervention_name>
    <description>Postoperative contramal consumption, pain intensity, side effects</description>
    <arm_group_label>550 mg naproxen sodium and 30mg codeine</arm_group_label>
    <other_name>Apranax plus</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>300 mg paracetamol and 30 mg codeine</intervention_name>
    <description>Postoperative contramal consumption, pain intensity, side effects</description>
    <arm_group_label>300 mg paracetamol and 30 mg codeine</arm_group_label>
    <other_name>geralgine K</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo tablet</intervention_name>
    <description>Postoperative contramal consumption, pain intensity, side effects</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) 1 or 2 status patients scheduled for an&#xD;
             elective lumbar disc surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  were known allergies to any of the drugs used in this study&#xD;
&#xD;
          -  peptic ulcer disease&#xD;
&#xD;
          -  hepatic and renal dysfunction,&#xD;
&#xD;
          -  emergency surgery&#xD;
&#xD;
          -  inability to provide informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Reyhan Polat, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ministry of Health</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Reyhan Polat, MD</last_name>
    <phone>+905326734310</phone>
    <email>reyhanp9@gmail.com</email>
  </overall_contact>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>September 27, 2014</study_first_submitted>
  <study_first_submitted_qc>October 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2014</study_first_posted>
  <last_update_submitted>December 25, 2014</last_update_submitted>
  <last_update_submitted_qc>December 25, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 30, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Diskapi Yildirim Beyazit Education and Research Hospital</investigator_affiliation>
    <investigator_full_name>Reyhan Polat</investigator_full_name>
    <investigator_title>Medical Doctor</investigator_title>
  </responsible_party>
  <keyword>naproxen sodium codeine</keyword>
  <keyword>paracetamol codeine</keyword>
  <keyword>disk surgery</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>
    <mesh_term>Naproxen</mesh_term>
    <mesh_term>Codeine</mesh_term>
  </intervention_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/NCT02255955
org study id: Pstoperative pain
nct id: NCT02255955
lead sponsor: 
has dmc: Yes
Compare the analgesic effects of naproxen sodium codeine, paracetamol codeine and placebo on
      postoperative pain and tramadol (Contramal) consumption during the first 24 hour after a
      lumbar disk surgery.
Compare the analgesic effects of naproxen sodium codeine paracetamol codeine and placebo on
      postoperative pain intensity measured by the visual analogue scale, and evaluated tramadol
      consumption and related side effects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Contramal consumption
time frame: Postoperative 24 hour
description: To assess contramal consumption
measure: Side effects
time frame: postoperative 24 hour
description: nausea and vomiting
measure: Pain intensity
time frame: postoperative 24 hour
description: To assess postoperative pain intensity by visual analog scale
arm group label: 550 mg naproxen sodium and 30mg codeine
arm group type: Experimental
description: Preoperatively patients received oral naproxen sodium codeine, postop contramal infused by PCA, and postoperative contramal consumption, side effects pain intensity measured by VAS.
arm group label: 300 mg paracetamol and 30 mg codeine
arm group type: Active Comparator
description: Preoperatively patients received oral paracetamol codeine, postop contramal infused by PCA, and postoperative contramal consumption, side effects pain intensity measured by VAS.
arm group label: Placebo
arm group type: Placebo Comparator
description: Preoperatively patients received oral placebo tablet, postop contramal infused by PCA, and postoperative contramal consumption, side effects pain intensity measured by VAS.
intervention type: Drug
intervention name: 550 mg naproxen sodium and 30mg codeine
description: Postoperative contramal consumption, pain intensity, side effects
arm group label: 550 mg naproxen sodium and 30mg codeine
other name: Apranax plus
intervention type: Drug
intervention name: 300 mg paracetamol and 30 mg codeine
description: Postoperative contramal consumption, pain intensity, side effects
arm group label: 300 mg paracetamol and 30 mg codeine
other name: geralgine K
intervention type: Drug
intervention name: placebo tablet
description: Postoperative contramal consumption, pain intensity, side effects
arm group label: Placebo
criteria: 
gender: All
minimum age: 16 Years
maximum age: 85 Years
healthy volunteers: No
last name: Reyhan Polat, MD
role: Principal Investigator
affiliation: Ministry of Health
last name: Reyhan Polat, MD
phone: +905326734310
email: reyhanp9@gmail.com
responsible party type: Principal Investigator
investigator affiliation: Diskapi Yildirim Beyazit Education and Research Hospital
investigator full name: Reyhan Polat
investigator title: Medical Doctor
mesh term: Pain, Postoperative
mesh term: Acetaminophen
mesh term: Naproxen
mesh term: Codeine