<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/NCT03796403</url>
  </required_header>
  <id_info>
    <org_study_id>Suphetgyn2516</org_study_id>
    <nct_id>NCT03796403</nct_id>
  </id_info>
  <brief_title>Bupivacaine Plus Diclofenac Versus Bupivacaine Alone for Postoperative Pain Relief in Gynecologic Cancer Patients</brief_title>
  <official_title>Comparison of Bupivacaine Peritoneal Infiltration and Intramuscular Diclofenac Versus Bupivacaine Peritoneal Infiltration Alone for Postoperative Pain Relief in Gynecologic Cancer Patients Undergoing Open Surgery</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>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      compare the postoperative pain between Bupivacaine peritoneal Infiltration plus immediately&#xD;
      postoperative intramuscular Diclofenac and Bupivacaine peritoneal infiltration alone by using&#xD;
      visual analogue score (VAS).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective is to compare the postoperative pain between Bupivacaine peritoneal&#xD;
      Infiltration plus immediately postoperative intramuscular Diclofenac and Bupivacaine&#xD;
      peritoneal infiltration alone by using visual analogue score (VAS). The secondary objective&#xD;
      is to evaluate the time to first dose and the total amount of morphine requirement after the&#xD;
      operation in both groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Diclofenac is no longer recommend for intramuscular administration by the Medical Council of&#xD;
    Thailand&#xD;
  </why_stopped>
  <start_date type="Actual">February 15, 2019</start_date>
  <completion_date type="Actual">December 30, 2019</completion_date>
  <primary_completion_date type="Actual">September 30, 2019</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>
    <intervention_model_description>randomized into two groups by simple random. In bupivacaine and diclofenac group (n=70), Twenty ml of bupivacaine was infiltrated into surgical-site peritoneum and diclofenac 75 mg was intramuscularly injected immediately after complete the procedure and the operative field was covered with sterile adhesive wound dressing. In the bupivacaine alone group (n=70), 20 ml of bupivacaine was infiltrated into surgical-site peritoneum before closure and a 3 ml of sterile water was intramuscularly injected immediately after complete the procedure. Intravenous morphine injection was given if the pain score was more than 6 in the first 24 hours. Post-operation; time to first request of pain medication, doses, side effects, and vital signs were recorded. VAS was recorded at 2, 6, 12 and 24 hours post-operation and patients' satisfied score was recorded after 24 hours post-operation.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Post-operative pain relief</measure>
    <time_frame>During acute post operation peroid as 24 hours post operation</time_frame>
    <description>compare the postoperative pain between Bupivacaine peritoneal Infiltration plus immediately postoperative intramuscular Diclofenac and Bupivacaine peritoneal infiltration alone by using visual analogue score(VAS). Score 0-10 .When Score is higher than 5 score ,the pateint will gain the analgesia as opioid.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Morphine requirement</measure>
    <time_frame>During acute post operation period as 24 hours post operation</time_frame>
    <description>evaluate the time to first dose post operation and the total amount of morphine requirement after the operation in both groups. Score 0-10 .When Score is higher than 5 score ,the pateint will gain the analgesia as opioid.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">140</enrollment>
  <condition>Post-operative Pain</condition>
  <arm_group>
    <arm_group_label>diclofenac and bupivacaine group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Twenty mL of bupivacaine was infiltrated into surgical-site peritoneum , divided in 10 sites before closure, and diclofenac 75 mg (3 mL) was intramuscularly injected immediately after complete the procedure and the operative field was covered with sterile adhesive wound dressing.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>bupivacaine only group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Twenty mL of bupivacaine was infiltrated into surgical-site peritoneum, divided in 10 sites before closure and a 3 mL of sterile water was intramuscularly injected immediately after complete the procedure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Diclofenac</intervention_name>
    <description>Twenty mL of bupivacaine was infiltrated into surgical-site peritoneum , divided in 10 sites before closure, and diclofenac 75 mg (3 mL) was intramuscularly injected immediately after complete the procedure and the operative field was covered with sterile adhesive wound dressing.</description>
    <arm_group_label>bupivacaine only group</arm_group_label>
    <arm_group_label>diclofenac and bupivacaine group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  gynecologic cancer patients ,i.e. cervical cancer, endometrial cancer, or ovarian&#xD;
             tumor suspicious for malignancy&#xD;
&#xD;
          -  who has scheduled for operation via laparotomy route&#xD;
&#xD;
          -  Women who has ASA physical status I-II&#xD;
&#xD;
          -  All of the have age more than 20 years old&#xD;
&#xD;
          -  able to communicate in Thai&#xD;
&#xD;
          -  Women who agrees to participate in this study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient who had emergency conditions - indication for emergency operation&#xD;
&#xD;
          -  intraoperative cardiac arrhythmia&#xD;
&#xD;
          -  operation purpose for only tumor biopsy&#xD;
&#xD;
               -  Women who have abnormal kidney function test (Cr &gt; 1.5)&#xD;
&#xD;
               -  Women with history of gastrointestinal bleeding&#xD;
&#xD;
               -  Women who take the antiplatelet or anticoagulant medications&#xD;
&#xD;
               -  Women with history of allergy to bupivacaine and NSAIDs&#xD;
&#xD;
               -  Women who cannot evaluated pain score&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Gynecologic cancer patients</gender_description>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Suphet Tuipae, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rajavithi Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rajavithi hospital</name>
      <address>
        <city>Bangkok</city>
        <zip>10400</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>September 28, 2018</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <last_update_submitted>October 21, 2020</last_update_submitted>
  <last_update_submitted_qc>October 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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>Diclofenac</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/NCT03796403
org study id: Suphetgyn2516
nct id: NCT03796403
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
compare the postoperative pain between Bupivacaine peritoneal Infiltration plus immediately
      postoperative intramuscular Diclofenac and Bupivacaine peritoneal infiltration alone by using
      visual analogue score (VAS).
The primary objective is to compare the postoperative pain between Bupivacaine peritoneal
      Infiltration plus immediately postoperative intramuscular Diclofenac and Bupivacaine
      peritoneal infiltration alone by using visual analogue score (VAS). The secondary objective
      is to evaluate the time to first dose and the total amount of morphine requirement after the
      operation in both groups.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: randomized into two groups by simple random. In bupivacaine and diclofenac group (n=70), Twenty ml of bupivacaine was infiltrated into surgical-site peritoneum and diclofenac 75 mg was intramuscularly injected immediately after complete the procedure and the operative field was covered with sterile adhesive wound dressing. In the bupivacaine alone group (n=70), 20 ml of bupivacaine was infiltrated into surgical-site peritoneum before closure and a 3 ml of sterile water was intramuscularly injected immediately after complete the procedure. Intravenous morphine injection was given if the pain score was more than 6 in the first 24 hours. Post-operation; time to first request of pain medication, doses, side effects, and vital signs were recorded. VAS was recorded at 2, 6, 12 and 24 hours post-operation and patients' satisfied score was recorded after 24 hours post-operation.
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Post-operative pain relief
time frame: During acute post operation peroid as 24 hours post operation
description: compare the postoperative pain between Bupivacaine peritoneal Infiltration plus immediately postoperative intramuscular Diclofenac and Bupivacaine peritoneal infiltration alone by using visual analogue score(VAS). Score 0-10 .When Score is higher than 5 score ,the pateint will gain the analgesia as opioid.
measure: Morphine requirement
time frame: During acute post operation period as 24 hours post operation
description: evaluate the time to first dose post operation and the total amount of morphine requirement after the operation in both groups. Score 0-10 .When Score is higher than 5 score ,the pateint will gain the analgesia as opioid.
arm group label: diclofenac and bupivacaine group
arm group type: Experimental
description: Twenty mL of bupivacaine was infiltrated into surgical-site peritoneum , divided in 10 sites before closure, and diclofenac 75 mg (3 mL) was intramuscularly injected immediately after complete the procedure and the operative field was covered with sterile adhesive wound dressing.
arm group label: bupivacaine only group
arm group type: Placebo Comparator
description: Twenty mL of bupivacaine was infiltrated into surgical-site peritoneum, divided in 10 sites before closure and a 3 mL of sterile water was intramuscularly injected immediately after complete the procedure.
intervention type: Other
intervention name: Diclofenac
description: Twenty mL of bupivacaine was infiltrated into surgical-site peritoneum , divided in 10 sites before closure, and diclofenac 75 mg (3 mL) was intramuscularly injected immediately after complete the procedure and the operative field was covered with sterile adhesive wound dressing.
arm group label: bupivacaine only group
arm group label: diclofenac and bupivacaine group
criteria: 
gender: Female
gender based: Yes
gender description: Gynecologic cancer patients
minimum age: 21 Years
maximum age: 70 Years
healthy volunteers: No
last name: Suphet Tuipae, MD
role: Principal Investigator
affiliation: Rajavithi Hospital
facility: 
country: Thailand
responsible party type: Sponsor
mesh term: Pain, Postoperative
mesh term: Diclofenac
sharing ipd: No