<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/NCT04490980</url>
  </required_header>
  <id_info>
    <org_study_id>TJ-C20200119</org_study_id>
    <nct_id>NCT04490980</nct_id>
  </id_info>
  <brief_title>The Analgesic Effect of Butorphanol After Cesarean Section</brief_title>
  <official_title>The Analgesic Effect of Butorphanol After Cesarean Section</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tongji Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tongji 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>
      We evaluated the clinical effect of Butorphanol on postoperative analgesia by observing the&#xD;
      vital signs of patients, general condition of newborns and pain assessment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">November 30, 2020</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change from Visual Analogue Score for pain</measure>
    <time_frame>assess VAS at 24 hours, 25 hours, 26 hours, 27 hours, 30 hours, 36 hours after the cesarean section</time_frame>
    <description>VAS is the most common pain scale for quantification. The score is higher, the patient will be more painful. That will indicate if the analgesia is effective. Visual analog scale (VAS) ranging from 0 to 10 (with 10 representing the worst pain imaginable) to measure the degree of pain for participants</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>heart rates</measure>
    <time_frame>at 24 hours, 30 hours, 36 hours after the cesarean section</time_frame>
    <description>heart rates（bpm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>jaundice index of the newborn,1 minute and 5 minutes Apgar score</measure>
    <time_frame>jaundice index: 24 hours, 48 hours, 72 hours after the cesarean section</time_frame>
    <description>Neonatal Apgar scores at the first and fifth minute.The score indicates the infant s' conditions, including heart rate, breathing, muscle tone, reflex response, color. Each characteristic is given an individual score; two points for each of the five categories if all is completely well; then all scores are totaled. The score is from 0 to 10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>blood pressure</measure>
    <time_frame>at 24 hours, 30 hours, 36 hours after the cesarean section</time_frame>
    <description>blood pressure(mmHg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>breath</measure>
    <time_frame>at 24 hours, 30 hours, 36 hours after the cesarean section</time_frame>
    <description>breath(bpm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pulse</measure>
    <time_frame>at 24 hours, 30 hours, 36 hours after the cesarean section</time_frame>
    <description>pulse(bpm)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Analgesia</condition>
  <arm_group>
    <arm_group_label>Observed group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>butorphanol</intervention_name>
    <description>Observed group:Intravenous drip of Butorphanol in patients after cesarean section;control group: intravenous drip of saline in patients after cesarean section</description>
    <arm_group_label>Observed group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Healthy women at term (37 to 42 weeks of gestation), who desired cesarean section were&#xD;
        eligible to participate. undergoing ；No drug sensitive history&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients with a history of anesthetics allergy and patients with preterm labor, multiple&#xD;
        pregnancies and severe obstetric complications&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xun Gong</last_name>
    <role>Study Chair</role>
    <affiliation>Tongji Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xun Gong, Doctor</last_name>
    <phone>13886174675</phone>
    <email>gongxun4019@163.com</email>
  </overall_contact>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>February 3, 2020</study_first_submitted>
  <study_first_submitted_qc>July 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>July 25, 2020</last_update_submitted>
  <last_update_submitted_qc>July 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tongji Hospital</investigator_affiliation>
    <investigator_full_name>Deng Dongrui</investigator_full_name>
    <investigator_title>professor,chief doctor</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Butorphanol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04490980
org study id: TJ-C20200119
nct id: NCT04490980
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
We evaluated the clinical effect of Butorphanol on postoperative analgesia by observing the
      vital signs of patients, general condition of newborns and pain assessment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: change from Visual Analogue Score for pain
time frame: assess VAS at 24 hours, 25 hours, 26 hours, 27 hours, 30 hours, 36 hours after the cesarean section
description: VAS is the most common pain scale for quantification. The score is higher, the patient will be more painful. That will indicate if the analgesia is effective. Visual analog scale (VAS) ranging from 0 to 10 (with 10 representing the worst pain imaginable) to measure the degree of pain for participants
measure: heart rates
time frame: at 24 hours, 30 hours, 36 hours after the cesarean section
description: heart rates（bpm)
measure: jaundice index of the newborn,1 minute and 5 minutes Apgar score
time frame: jaundice index: 24 hours, 48 hours, 72 hours after the cesarean section
description: Neonatal Apgar scores at the first and fifth minute.The score indicates the infant s' conditions, including heart rate, breathing, muscle tone, reflex response, color. Each characteristic is given an individual score; two points for each of the five categories if all is completely well; then all scores are totaled. The score is from 0 to 10.
measure: blood pressure
time frame: at 24 hours, 30 hours, 36 hours after the cesarean section
description: blood pressure(mmHg)
measure: breath
time frame: at 24 hours, 30 hours, 36 hours after the cesarean section
description: breath(bpm)
measure: pulse
time frame: at 24 hours, 30 hours, 36 hours after the cesarean section
description: pulse(bpm)
arm group label: Observed group
arm group type: Experimental
arm group label: Control group
arm group type: No Intervention
intervention type: Drug
intervention name: butorphanol
description: Observed group:Intravenous drip of Butorphanol in patients after cesarean section;control group: intravenous drip of saline in patients after cesarean section
arm group label: Observed group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Xun Gong
role: Study Chair
affiliation: Tongji Hospital
last name: Xun Gong, Doctor
phone: 13886174675
email: gongxun4019@163.com
responsible party type: Principal Investigator
investigator affiliation: Tongji Hospital
investigator full name: Deng Dongrui
investigator title: professor,chief doctor
mesh term: Butorphanol
sharing ipd: No