<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/NCT03792009</url>
  </required_header>
  <id_info>
    <org_study_id>2019-01-001</org_study_id>
    <nct_id>NCT03792009</nct_id>
  </id_info>
  <brief_title>Paracervical Block in Laparoscopic Hysterectomy</brief_title>
  <acronym>PALAPA</acronym>
  <official_title>A Randomized, Multi-center, Double-blind, Placebo-controlled Trial of Paracervical Block Before Total Laparoscopic Hysterectomy for Postoperative Pain Control (PALAPA):</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kangbuk Samsung Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kangbuk Samsung Hospital</source>
  <oversight_info>
    <has_dmc>No</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>
      It remains controversial whether paracervical block should be performed as a powerful&#xD;
      strategy for pain relief in total laparoscopic hysterectomy (TLH), because convincing&#xD;
      conclusions are difficult to draw because of the heterogeneous and contradictory nature of&#xD;
      the literature. Therefore, the aim of this study was to evaluate the efficacy of paracervical&#xD;
      blocks using with 0.5% bupivacaine prior to TLHs for benign gynecologic conditions on&#xD;
      postoperative pain relief.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Postoperative pain management is an important component of patient care and satisfaction&#xD;
      after surgery. Although contemporary changes such as a shift to minimally invasive approaches&#xD;
      and an introduction of the enhanced recovery after surgery (ERAS) program have resulted in&#xD;
      improved outcomes, a large number of patients undergoing surgery have still inadequate pain&#xD;
      control. Paracervical block is a single-injection of anesthetic around the cervix at a depth&#xD;
      of about 1 cm, diffusing anesthetic into the second to fourth sacral nerve roots passing&#xD;
      through Frankenhäuser plexus. Moreover, recent randomized trials demonstrated that patients&#xD;
      who underwent vaginal hysterectomy and received a paracervical block had lower postoperative&#xD;
      pain in the first 3-6 hours compared with placebo.&#xD;
&#xD;
      However, it remains controversial whether paracervical block should be performed as a&#xD;
      powerful strategy for pain relief in total laparoscopic hysterectomy (TLH), because&#xD;
      convincing conclusions are difficult to draw because of the heterogeneous and contradictory&#xD;
      nature of the literature. Therefore, the aim of this study was to evaluate the efficacy of&#xD;
      paracervical blocks using with 0.5% bupivacaine prior to TLHs for benign gynecologic&#xD;
      conditions on postoperative pain relief.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 21, 2019</start_date>
  <completion_date type="Anticipated">February 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">February 1, 2021</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative pain</measure>
    <time_frame>at 6-hour after surgery</time_frame>
    <description>The scale was presented as a 10-cm line with verbal descriptors ranging from &quot;no pain&quot; to &quot;worst imaginable pain&quot;.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Frequency of pills/injections requested</measure>
    <time_frame>Within 24-hour after surgery</time_frame>
    <description>Narcotic and non-narcotic use were measured by number of pills/injections requested within 24-hour after surgery.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">86</enrollment>
  <condition>Uterine Fibroid</condition>
  <condition>Adenomyosis</condition>
  <arm_group>
    <arm_group_label>Paracervical block with 5% bupivacaine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The paracervical injection with 10 mL of 0.5% bupivacaine plus 1:200,000 epinephrine was administrated by the second assistant surgeon into the cervicovaginal junction at 3 and 9 o'clock with a depth of 1 cm after intubation but before fixation of uterine manipulator onto the cervix.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Paracervical block with normal saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The paracervical injection with 10 mL of normal saline was administrated by the second assistant surgeon into the cervicovaginal junction at 3 and 9 o'clock with a depth of 1 cm after intubation but before fixation of uterine manipulator onto the cervix.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Paracervical block</intervention_name>
    <description>The paracervical injection with 10 mL of 0.5% bupivacaine plus 1:200,000 epinephrine or normal saline was administrated by the second assistant surgeon into the cervicovaginal junction at 3 and 9 o'clock with a depth of 1 cm after intubation but before fixation of uterine manipulator onto the cervix.</description>
    <arm_group_label>Paracervical block with 5% bupivacaine</arm_group_label>
    <arm_group_label>Paracervical block with normal saline</arm_group_label>
    <other_name>Experimental arm</other_name>
    <other_name>Control arm</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>5% bupivacaine</intervention_name>
    <description>The paracervical injection with 10 mL of 0.5% bupivacaine plus 1:200,000 epinephrine was administrated by the second assistant surgeon into the cervicovaginal junction at 3 and 9 o'clock with a depth of 1 cm after intubation but before fixation of uterine manipulator onto the cervix.</description>
    <arm_group_label>Paracervical block with 5% bupivacaine</arm_group_label>
    <other_name>Experimental arm</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal saline</intervention_name>
    <description>The paracervical injection with 10 mL of normal saline was administrated by the second assistant surgeon into the cervicovaginal junction at 3 and 9 o'clock with a depth of 1 cm after intubation but before fixation of uterine manipulator onto the cervix.</description>
    <arm_group_label>Paracervical block with normal saline</arm_group_label>
    <other_name>Control arm</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age between 18 and 65 years&#xD;
&#xD;
          -  American Society of Anesthesiologists physical status (ASAPS) classification I-II&#xD;
&#xD;
          -  the absence of pregnancy at the time of surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of cervical surgery such as conization or cerclage&#xD;
&#xD;
          -  inability to perform the paracervical block due to anatomical abnormalities (i.e.,&#xD;
             very atrophic or small cervix)&#xD;
&#xD;
          -  allergy to bupivacaine, planned concomitant surgical procedures involving extensive&#xD;
             additional tissue manipulation such as pelvic lymph node dissection&#xD;
&#xD;
          -  any concomitant surgery of pelvic floor repair (uterosacral ligament suspension or&#xD;
             sacrocolpopexy) or vaginal procedures (anterior or posterior colporrhaphy or&#xD;
             mid-urethral slings), previously taking opioids for chronic pain&#xD;
&#xD;
          -  inability to accurately express their pain&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Taejong Song, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kangbuk Samsung Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Taejong Song, M.D., Ph.D.</last_name>
    <phone>+821040358405</phone>
    <email>taejong.song@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Su Yaen Kim, M.D.</last_name>
    <phone>+82220012036</phone>
    <email>suyeon0819.kim@samsung.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>03181</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Kangbuk Samsung Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>110-746</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Taejong Song, MD PhD</last_name>
      <phone>82-2-2001-2582</phone>
      <email>taejong.song@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Taejong Song, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Wonju Severance Christian Hospital</name>
      <address>
        <city>Wonju</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>San-Hui Lee, M.D.</last_name>
      <phone>+821040358405</phone>
      <email>saniarami@gmail.com</email>
    </contact>
    <investigator>
      <last_name>San-Hui Lee, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>December 28, 2018</study_first_submitted>
  <study_first_submitted_qc>December 31, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</study_first_posted>
  <last_update_submitted>February 21, 2019</last_update_submitted>
  <last_update_submitted_qc>February 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kangbuk Samsung Hospital</investigator_affiliation>
    <investigator_full_name>Taejong Song</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leiomyoma</mesh_term>
    <mesh_term>Adenomyosis</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>
  <pending_results>
    <submitted>December 31, 2020</submitted>
    <submission_canceled>January 18, 2021</submission_canceled>
    <submitted>January 18, 2021</submitted>
    <returned>February 5, 2021</returned>
  </pending_results>
  <!-- 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/NCT03792009
org study id: 2019-01-001
nct id: NCT03792009
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
It remains controversial whether paracervical block should be performed as a powerful
      strategy for pain relief in total laparoscopic hysterectomy (TLH), because convincing
      conclusions are difficult to draw because of the heterogeneous and contradictory nature of
      the literature. Therefore, the aim of this study was to evaluate the efficacy of paracervical
      blocks using with 0.5% bupivacaine prior to TLHs for benign gynecologic conditions on
      postoperative pain relief.
Postoperative pain management is an important component of patient care and satisfaction
      after surgery. Although contemporary changes such as a shift to minimally invasive approaches
      and an introduction of the enhanced recovery after surgery (ERAS) program have resulted in
      improved outcomes, a large number of patients undergoing surgery have still inadequate pain
      control. Paracervical block is a single-injection of anesthetic around the cervix at a depth
      of about 1 cm, diffusing anesthetic into the second to fourth sacral nerve roots passing
      through Frankenhäuser plexus. Moreover, recent randomized trials demonstrated that patients
      who underwent vaginal hysterectomy and received a paracervical block had lower postoperative
      pain in the first 3-6 hours compared with placebo.

      However, it remains controversial whether paracervical block should be performed as a
      powerful strategy for pain relief in total laparoscopic hysterectomy (TLH), because
      convincing conclusions are difficult to draw because of the heterogeneous and contradictory
      nature of the literature. Therefore, the aim of this study was to evaluate the efficacy of
      paracervical blocks using with 0.5% bupivacaine prior to TLHs for benign gynecologic
      conditions on postoperative pain relief.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Postoperative pain
time frame: at 6-hour after surgery
description: The scale was presented as a 10-cm line with verbal descriptors ranging from "no pain" to "worst imaginable pain".
measure: Frequency of pills/injections requested
time frame: Within 24-hour after surgery
description: Narcotic and non-narcotic use were measured by number of pills/injections requested within 24-hour after surgery.
arm group label: Paracervical block with 5% bupivacaine
arm group type: Experimental
description: The paracervical injection with 10 mL of 0.5% bupivacaine plus 1:200,000 epinephrine was administrated by the second assistant surgeon into the cervicovaginal junction at 3 and 9 o'clock with a depth of 1 cm after intubation but before fixation of uterine manipulator onto the cervix.
arm group label: Paracervical block with normal saline
arm group type: Placebo Comparator
description: The paracervical injection with 10 mL of normal saline was administrated by the second assistant surgeon into the cervicovaginal junction at 3 and 9 o'clock with a depth of 1 cm after intubation but before fixation of uterine manipulator onto the cervix.
intervention type: Device
intervention name: Paracervical block
description: The paracervical injection with 10 mL of 0.5% bupivacaine plus 1:200,000 epinephrine or normal saline was administrated by the second assistant surgeon into the cervicovaginal junction at 3 and 9 o'clock with a depth of 1 cm after intubation but before fixation of uterine manipulator onto the cervix.
arm group label: Paracervical block with 5% bupivacaine
arm group label: Paracervical block with normal saline
other name: Experimental arm
other name: Control arm
intervention type: Drug
intervention name: 5% bupivacaine
description: The paracervical injection with 10 mL of 0.5% bupivacaine plus 1:200,000 epinephrine was administrated by the second assistant surgeon into the cervicovaginal junction at 3 and 9 o'clock with a depth of 1 cm after intubation but before fixation of uterine manipulator onto the cervix.
arm group label: Paracervical block with 5% bupivacaine
other name: Experimental arm
intervention type: Drug
intervention name: Normal saline
description: The paracervical injection with 10 mL of normal saline was administrated by the second assistant surgeon into the cervicovaginal junction at 3 and 9 o'clock with a depth of 1 cm after intubation but before fixation of uterine manipulator onto the cervix.
arm group label: Paracervical block with normal saline
other name: Control arm
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Taejong Song, M.D., Ph.D.
role: Principal Investigator
affiliation: Kangbuk Samsung Hospital
last name: Taejong Song, M.D., Ph.D.
phone: +821040358405
email: taejong.song@gmail.com
last name: Su Yaen Kim, M.D.
phone: +82220012036
email: suyeon0819.kim@samsung.com
facility: 
status: Suspended
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Kangbuk Samsung Hospital
investigator full name: Taejong Song
investigator title: Professor
mesh term: Leiomyoma
mesh term: Adenomyosis
mesh term: Bupivacaine
sharing ipd: No
submitted: December 31, 2020
submission canceled: January 18, 2021
submitted: January 18, 2021
returned: February 5, 2021