<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/NCT03288428</url>
  </required_header>
  <id_info>
    <org_study_id>NABUMORPHINE</org_study_id>
    <nct_id>NCT03288428</nct_id>
  </id_info>
  <brief_title>Analgesia Comparison of Nalbuphine and Morphine for Laparoscopic Myomectomy</brief_title>
  <official_title>Analgesia Comparison of Nalbuphine and Morphine for Laparoscopic Myomectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University First Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University First Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      to compare the analgesia and side effect of nalbuphine and morphine for elective Laparoscopic&#xD;
      myomectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To compare the analgesia and side effect of nalbuphine and morphine for elective Laparoscopic&#xD;
      myomectomy, by using patient controlled analgesia postoperatively, a randomized, double blind&#xD;
      clinical trial. Patients undergoing elective Laparoscopic myomectomy are randomly divided&#xD;
      into two groups: nalbuphine and morphine groups. All patients are under general anesthesia&#xD;
      with routine methods. The nalbuphine group receive postoperative patient controlled analgesia&#xD;
      using nalbuphine 30mg/120ml, while the morphine group receive postoperative patient&#xD;
      controlled analgesia using morphine 60mg/120ml. Perioperative parameters are to be collected&#xD;
      to compare the two groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 1, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2018</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2018</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>
    <masking_description>double blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>numerical rating scale</measure>
    <time_frame>24 hr post-operatively</time_frame>
    <description>1-10</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>nalbuphine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>using nalbuphine for patient controlled analgesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>morphine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>using morphine for patient controlled analgesia</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nalbuphine</intervention_name>
    <description>patient controlled analgesia with Nalbuphine</description>
    <arm_group_label>nalbuphine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Morphine</intervention_name>
    <description>patient controlled analgesia with Morphine</description>
    <arm_group_label>morphine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  elective Laparoscopic myomectomy patients 24hr post-operative patient controlled&#xD;
             analgesia analgesia no mild or severe liver or renal disfunction&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  can't understand patient controlled analgesia device refuse trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Yan Zhou, MD</last_name>
    <phone>13641202040</phone>
    <email>zhouyanlion@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>First hospital Peking University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yan Zhou, doctor</last_name>
      <phone>13641202040</phone>
      <email>anesth.zhouyan9@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>June 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 20, 2017</study_first_posted>
  <last_update_submitted>November 1, 2017</last_update_submitted>
  <last_update_submitted_qc>November 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University First Hospital</investigator_affiliation>
    <investigator_full_name>Yan Zhou, MD</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <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>Morphine</mesh_term>
    <mesh_term>Nalbuphine</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/NCT03288428
org study id: NABUMORPHINE
nct id: NCT03288428
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
to compare the analgesia and side effect of nalbuphine and morphine for elective Laparoscopic
      myomectomy.
To compare the analgesia and side effect of nalbuphine and morphine for elective Laparoscopic
      myomectomy, by using patient controlled analgesia postoperatively, a randomized, double blind
      clinical trial. Patients undergoing elective Laparoscopic myomectomy are randomly divided
      into two groups: nalbuphine and morphine groups. All patients are under general anesthesia
      with routine methods. The nalbuphine group receive postoperative patient controlled analgesia
      using nalbuphine 30mg/120ml, while the morphine group receive postoperative patient
      controlled analgesia using morphine 60mg/120ml. Perioperative parameters are to be collected
      to compare the two groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
masking description: double blind
measure: numerical rating scale
time frame: 24 hr post-operatively
description: 1-10
arm group label: nalbuphine
arm group type: Experimental
description: using nalbuphine for patient controlled analgesia
arm group label: morphine
arm group type: Active Comparator
description: using morphine for patient controlled analgesia
intervention type: Drug
intervention name: Nalbuphine
description: patient controlled analgesia with Nalbuphine
arm group label: nalbuphine
intervention type: Drug
intervention name: Morphine
description: patient controlled analgesia with Morphine
arm group label: morphine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Yan Zhou, MD
phone: 13641202040
email: zhouyanlion@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking University First Hospital
investigator full name: Yan Zhou, MD
investigator title: MD
mesh term: Pain, Postoperative
mesh term: Morphine
mesh term: Nalbuphine