<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/NCT03259243</url>
  </required_header>
  <id_info>
    <org_study_id>RAJLAPGYNE</org_study_id>
    <nct_id>NCT03259243</nct_id>
  </id_info>
  <brief_title>Comparison of Efficacy of Bupivacaine for Relief Postoperative Pain in Women Undergoing Laparoscopic Gynecologic Surgery</brief_title>
  <official_title>Port Site Infiltration With Bupivacaine for Reduction of Postoperative Pain in Woman Undergoing Gynecologic Laparoscopy: A Randomized, Factorial, Double-Blind, Controlled Trial</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>
      To comparison of efficacy of Bupivacaine for relief postoperative pain in women undergoing&#xD;
      laparoscopic gynecologic surgery&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Gynecologic laparoscopic procedures have become more common nowadays because of their&#xD;
      benefits in less tissue trauma, less perioperative morbidity and shorter hospital stays&#xD;
      compared with laparotomy. But postoperative pain still be the most concerning problems&#xD;
      including discomfort at incision sites, Pain due to pneumoperitoneum stretching the&#xD;
      intraabdominal cavity and dissection of the abdominal and pelvic viscera.&#xD;
&#xD;
      Visceral pain is at maximal intensity during the first postoperative hours and is exacerbated&#xD;
      by coughing, respiratory movements, and mobilization. Because the pain comprises of several&#xD;
      factors, multimodal analgesic techniques are needed for effective postoperative analgesia and&#xD;
      brought to this study to compare efficacy of Bupivacaine for pain relief postoperatively in&#xD;
      women undergoing gynecologic laparoscopic surgery divided into 4 groups including preincision&#xD;
      and preclosure Bupivacaine injection collated with placebo group. The result is measurement&#xD;
      in postoperative pain score and amount of drug that using to reduce pain&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2017</start_date>
  <completion_date type="Actual">January 31, 2018</completion_date>
  <primary_completion_date type="Actual">October 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>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative pain after surgery</measure>
    <time_frame>24-48 hours after surgery</time_frame>
    <description>Postoperative pain score in intervention and placebo groups</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Among of pethidine use</measure>
    <time_frame>within 48 hours</time_frame>
    <description>Among of pethidine use to reduced postoperative pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of hospital stay</measure>
    <time_frame>within 7 days</time_frame>
    <description>Duration of hospital stay after surgery</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Postoperative Pain Score</condition>
  <arm_group>
    <arm_group_label>placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>0.9%Nacl (Placebo) 10 ml were port site infiltration prior skin incision and prior skin closure Drug: 0.9%Nacl Other Name: NSS</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Preincision Bupivacaine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>0.5% bupivacaine 10 ml (50 mg) were port site infiltration prior skin incision and 0.9%Nacl (Placebo) 10 ml were port site infiltration prior skin closure Drug: 0.5% bupivacaine 10 ml (50 mg) Other Name: Marcaine 0.9%Nacl (Placebo) 10 ml Other Name: NSS</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Preclosure bupivacaine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>0.9%Nacl (Placebo) 10 ml were port site infiltration prior skin incision and 0.5% bupivacaine 10 ml (50 mg) were port site infiltration prior skin closure Other Name: Marcaine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bupivacaine group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>0.5% bupivacaine 10 ml (50 mg) were port site infiltration prior skin incision and 0.5% bupivacaine 10 ml (50 mg) were port site infiltration prior skin closure Other Name: Marcaine</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine Hydrochloride</intervention_name>
    <description>0.5 Bupivacaine hydrochloride were port site infiltration preincision and preclosure injection</description>
    <arm_group_label>Bupivacaine group</arm_group_label>
    <arm_group_label>Preclosure bupivacaine</arm_group_label>
    <arm_group_label>Preincision Bupivacaine</arm_group_label>
    <arm_group_label>placebo group</arm_group_label>
    <other_name>0.5% Marcaine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient who undergoing gynecologic laparoscopic surgery&#xD;
&#xD;
          -  Patient who agrees to participate in this study&#xD;
&#xD;
          -  Patient able to speak and understand Thai&#xD;
&#xD;
          -  Patient able to complete the questionnaire&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with history of allergy in any kind anesthetic drug&#xD;
&#xD;
          -  Patient who pregnant&#xD;
&#xD;
          -  Patient who sign for single port gynecologic laparoscopic surgery or NOTE surgery&#xD;
&#xD;
          -  Patient whom the surgery is withhold or canceled&#xD;
&#xD;
          -  Patient whom the surgery is converted to laparotomy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Waetasleem Chema</name>
      <address>
        <city>Bangkok</city>
        <zip>10400</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 19, 2017</study_first_submitted>
  <study_first_submitted_qc>August 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 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>
  <keyword>Bupivacaine, Port site infiltration ,Postoperative pain ,Gynecologic laparoscopy</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>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/NCT03259243
org study id: RAJLAPGYNE
nct id: NCT03259243
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To comparison of efficacy of Bupivacaine for relief postoperative pain in women undergoing
      laparoscopic gynecologic surgery
Gynecologic laparoscopic procedures have become more common nowadays because of their
      benefits in less tissue trauma, less perioperative morbidity and shorter hospital stays
      compared with laparotomy. But postoperative pain still be the most concerning problems
      including discomfort at incision sites, Pain due to pneumoperitoneum stretching the
      intraabdominal cavity and dissection of the abdominal and pelvic viscera.

      Visceral pain is at maximal intensity during the first postoperative hours and is exacerbated
      by coughing, respiratory movements, and mobilization. Because the pain comprises of several
      factors, multimodal analgesic techniques are needed for effective postoperative analgesia and
      brought to this study to compare efficacy of Bupivacaine for pain relief postoperatively in
      women undergoing gynecologic laparoscopic surgery divided into 4 groups including preincision
      and preclosure Bupivacaine injection collated with placebo group. The result is measurement
      in postoperative pain score and amount of drug that using to reduce pain
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Postoperative pain after surgery
time frame: 24-48 hours after surgery
description: Postoperative pain score in intervention and placebo groups
measure: Among of pethidine use
time frame: within 48 hours
description: Among of pethidine use to reduced postoperative pain
measure: Duration of hospital stay
time frame: within 7 days
description: Duration of hospital stay after surgery
arm group label: placebo group
arm group type: Placebo Comparator
description: 0.9%Nacl (Placebo) 10 ml were port site infiltration prior skin incision and prior skin closure Drug: 0.9%Nacl Other Name: NSS
arm group label: Preincision Bupivacaine
arm group type: Experimental
description: 0.5% bupivacaine 10 ml (50 mg) were port site infiltration prior skin incision and 0.9%Nacl (Placebo) 10 ml were port site infiltration prior skin closure Drug: 0.5% bupivacaine 10 ml (50 mg) Other Name: Marcaine 0.9%Nacl (Placebo) 10 ml Other Name: NSS
arm group label: Preclosure bupivacaine
arm group type: Experimental
description: 0.9%Nacl (Placebo) 10 ml were port site infiltration prior skin incision and 0.5% bupivacaine 10 ml (50 mg) were port site infiltration prior skin closure Other Name: Marcaine
arm group label: Bupivacaine group
arm group type: Experimental
description: 0.5% bupivacaine 10 ml (50 mg) were port site infiltration prior skin incision and 0.5% bupivacaine 10 ml (50 mg) were port site infiltration prior skin closure Other Name: Marcaine
intervention type: Drug
intervention name: Bupivacaine Hydrochloride
description: 0.5 Bupivacaine hydrochloride were port site infiltration preincision and preclosure injection
arm group label: Bupivacaine group
arm group label: Preclosure bupivacaine
arm group label: Preincision Bupivacaine
arm group label: placebo group
other name: 0.5% Marcaine
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Thailand
responsible party type: Sponsor
mesh term: Pain, Postoperative
mesh term: Bupivacaine
sharing ipd: No