<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/NCT03039426</url>
  </required_header>
  <id_info>
    <org_study_id>RJBUPI</org_study_id>
    <nct_id>NCT03039426</nct_id>
  </id_info>
  <brief_title>Postoperative Cesarean Delivery Pain Relief; Diclofenac Versus Bupivacaine</brief_title>
  <official_title>A Randomized Comparison of Bupivacaine Peritoneal and Subcutaneous Infiltration Versus Diclofenac Intramuscular Injection for Postoperative Pain Relief in Patient Undergoing Cesarean Delivery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rajavithi Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rajavithi Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomized controlled trial, compared postoperative pain score in patient undergoing&#xD;
      cesarean delivery between bupivacaine peritoneal and subcutaneous infiltration and diclofenac&#xD;
      intramuscular injection&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Postoperative cesarean delivery was painful that can effect daily activity, resulted in poor&#xD;
      quality of life and required morphine injection to relief pain which had both maternal and&#xD;
      breastfeeding infancy side effect. So this study compare efficacy of diclofenac and&#xD;
      bupivacaine by measured the pain score and requirement of morphine injection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">December 30, 2017</completion_date>
  <primary_completion_date type="Actual">June 30, 2017</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>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Compared pain score change from baseline at 2, 6 and 24 hours at post-operation between 2 groups by visual analogue scale</measure>
    <time_frame>2, 6 and 24 hours post-operation</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Compared rescued dose of morphine injection</measure>
    <time_frame>Within 24 hours post-operation</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Cesarean Delivery</condition>
  <arm_group>
    <arm_group_label>Group Bupivacaine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>0.5% bupivacaine 20ml divided in two; 10 ml intraperitoneal infiltration and 10 ml subcutaneous infiltration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group Diclofenac</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>diclofenac 75 mg intramuscular, 2 hours postoperation</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine</intervention_name>
    <description>0.5% bupivacaine 20ml divided in two; 10 ml intraperitoneal infiltration and 10 ml subcutaneous infiltration</description>
    <arm_group_label>Group Bupivacaine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Diclofenac</intervention_name>
    <description>diclofenac 75 mg intramuscular, 2 hours postoperation</description>
    <arm_group_label>Group Diclofenac</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergo elective or urgency cesarean delivery at Rajavithi Hospital in&#xD;
             2016-2017&#xD;
&#xD;
               -  Urgency conditions: CPD, fail induction of labor, antepartum hemorrhage without&#xD;
                  hypovolemic shock, dystocia, previous cesarean section and active labor,&#xD;
                  malpresentation in labor, macrosomic presentation in labor&#xD;
&#xD;
          -  Pregnant women more than 20 years of age&#xD;
&#xD;
          -  Gestational age more than 37 week&#xD;
&#xD;
          -  Cesarean section under regional or general anesthesia&#xD;
&#xD;
          -  Ability to communicating, writing and reading Thai language&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to communicating or writing or reading Thai language&#xD;
&#xD;
          -  Contraindicated to bupivacaine or diclofenac or morphine&#xD;
&#xD;
          -  Pregnant women with emergency conditions&#xD;
&#xD;
          -  Have one or more complication of pregnancy&#xD;
&#xD;
          -  Intraoperative arrhythmia&#xD;
&#xD;
          -  Pregnant women less than 20 years of age&#xD;
&#xD;
          -  Regional anesthesia with morphine&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Natthida Mekwongtrakarn</name>
      <address>
        <city>Bangkok</city>
        <zip>10400</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rajavithi Hospital</name>
      <address>
        <city>Bangkok</city>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>September 28, 2016</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>October 20, 2020</last_update_submitted>
  <last_update_submitted_qc>October 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diclofenac</mesh_term>
    <mesh_term>Bupivacaine</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/NCT03039426
org study id: RJBUPI
nct id: NCT03039426
lead sponsor: 
has dmc: No
This randomized controlled trial, compared postoperative pain score in patient undergoing
      cesarean delivery between bupivacaine peritoneal and subcutaneous infiltration and diclofenac
      intramuscular injection
Postoperative cesarean delivery was painful that can effect daily activity, resulted in poor
      quality of life and required morphine injection to relief pain which had both maternal and
      breastfeeding infancy side effect. So this study compare efficacy of diclofenac and
      bupivacaine by measured the pain score and requirement of morphine injection.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Compared pain score change from baseline at 2, 6 and 24 hours at post-operation between 2 groups by visual analogue scale
time frame: 2, 6 and 24 hours post-operation
measure: Compared rescued dose of morphine injection
time frame: Within 24 hours post-operation
arm group label: Group Bupivacaine
arm group type: Experimental
description: 0.5% bupivacaine 20ml divided in two; 10 ml intraperitoneal infiltration and 10 ml subcutaneous infiltration
arm group label: Group Diclofenac
arm group type: Active Comparator
description: diclofenac 75 mg intramuscular, 2 hours postoperation
intervention type: Drug
intervention name: Bupivacaine
description: 0.5% bupivacaine 20ml divided in two; 10 ml intraperitoneal infiltration and 10 ml subcutaneous infiltration
arm group label: Group Bupivacaine
intervention type: Drug
intervention name: Diclofenac
description: diclofenac 75 mg intramuscular, 2 hours postoperation
arm group label: Group Diclofenac
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
country: Thailand
responsible party type: Sponsor
mesh term: Diclofenac
mesh term: Bupivacaine
sharing ipd: No