<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/NCT03268525</url>
  </required_header>
  <id_info>
    <org_study_id>0156-17-WOMC</org_study_id>
    <nct_id>NCT03268525</nct_id>
  </id_info>
  <brief_title>The Effect of Local Anesthesia on Postoperative Pain in Vaginal Hysterectomy</brief_title>
  <official_title>The Effect of Local Anesthesia on Postoperative Pain in Vaginal Hysterectomy: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wolfson Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wolfson Medical Center</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators aim is to study the effect of pre-operative local anesthetic on post&#xD;
      vaginal hysterectomy pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a double-blinded, randomized, controlled trial. Women who undergone elective vaginal&#xD;
      hysterectomy and gave their informed consent were included. Exclusion criteria included&#xD;
      additional abdominal, chronic pelvic pain, malignancy, and allergy to Bupivacaine.&#xD;
&#xD;
      Solutions of either Bupivacaine-Hydrochloride 0.5%, or Sodium-Chloride 0.9% as a placebo,&#xD;
      were prepared prior to surgery, according to randomization. The chosen solution was injected&#xD;
      before incision, as a modified paracervical block, and in each resection line (sacro-uterine&#xD;
      and cardinal ligaments). The amount of fluid administered was 10 ml. When colporrhaphy was&#xD;
      also performed, an additional 5 ml of solution were injected in the midline of the vaginal&#xD;
      wall prior to each incision line.&#xD;
&#xD;
      By utilizing the 10 cm Visual-analogue-scale (VAS) we examined the differences in&#xD;
      post-operative pain at rest at 3, 8, and 24 hours, and during ambulation at 8 and 24 hours&#xD;
      using multivariate linear regression models. We also assessed the differences in analgesics&#xD;
      given at the different time points between the groups using multivariate negative binomial&#xD;
      regression models.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">November 30, 2019</completion_date>
  <primary_completion_date type="Actual">November 30, 2019</primary_completion_date>
  <phase>Early Phase 1</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>Drug group versus placebo group</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>The surgeons, the pain assessing researchers, and the participating women will all be blinded to what the syringes contain.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Pain at movement</measure>
    <time_frame>24 hours</time_frame>
    <description>Movement-evoked pain will be scored after the operation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>pain at rest</measure>
    <time_frame>24 hours</time_frame>
    <description>Pain at rest will be scored with the woman lying in bed after the operation</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>Study</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Marcaine 0.5 % Injectable Solution will be injected before incision, and in a systematic fashion as a modified paracervical block. First, 2 ml will be injected through the vaginal fornices at 03.00, 06.00, 09.00, and 12.00 hours at 2 cm depth. Thus, 8 ml will be systematically injected around the cervical circumference before incision. In addition, 1 ml of the solution will be injected in each resection line (sacro-uterine and cardinal ligaments), adding up to a total of 10 ml. In case of performing additional anterior/ posterior colporrhaphy, additional solution of Marcaine 0.25%will be prepared: 5 ml of the solution will be injected to the cutting line of the anterior/ posterior vaginal wall, respectively, prior to incision.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Sodium Chloride 0.9% will be injected before incision, and in a systematic fashion as a modified paracervical block. First, 2 ml will be injected through the vaginal fornices at 03.00, 06.00, 09.00, and 12.00 hours at 2 cm depth. Thus, 8 ml will be systematically injected around the cervical circumference before incision. In addition, 1 ml of the solution will be injected in each resection line (sacro-uterine and cardinal ligaments), adding up to a total of 10 ml. In case of performing additional anterior/ posterior colporrhaphy, additional solution of Sodium Chloride 0.9% will be prepared: 5 ml of the solution will be injected to the cutting line of the anterior/ posterior vaginal wall, respectively, prior to incision.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Marcaine 0.5 % Injectable Solution</intervention_name>
    <description>Local infiltration by Marcaine 0.5% Injectable Solution prior to incision</description>
    <arm_group_label>Study</arm_group_label>
    <other_name>Study</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sodium Chloride 0.9%</intervention_name>
    <description>Local infiltration by Sodium Chloride 0.9% prior to incision</description>
    <arm_group_label>Control</arm_group_label>
    <other_name>Placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Elective vaginal hysterectomy on benign indication&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        additional abdominal, chronic pelvic pain, malignancy, and allergy to Bupivacaine.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shimon Ginat, MD</last_name>
    <role>Study Director</role>
    <affiliation>Wolfson Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Wolfson medical center</name>
      <address>
        <city>H̱olon</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>June 4, 2020</last_update_submitted>
  <last_update_submitted_qc>June 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wolfson Medical Center</investigator_affiliation>
    <investigator_full_name>Ohad Gluck</investigator_full_name>
    <investigator_title>OBGYN resident</investigator_title>
  </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>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/NCT03268525
org study id: 0156-17-WOMC
nct id: NCT03268525
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
The investigators aim is to study the effect of pre-operative local anesthetic on post
      vaginal hysterectomy pain.
This is a double-blinded, randomized, controlled trial. Women who undergone elective vaginal
      hysterectomy and gave their informed consent were included. Exclusion criteria included
      additional abdominal, chronic pelvic pain, malignancy, and allergy to Bupivacaine.

      Solutions of either Bupivacaine-Hydrochloride 0.5%, or Sodium-Chloride 0.9% as a placebo,
      were prepared prior to surgery, according to randomization. The chosen solution was injected
      before incision, as a modified paracervical block, and in each resection line (sacro-uterine
      and cardinal ligaments). The amount of fluid administered was 10 ml. When colporrhaphy was
      also performed, an additional 5 ml of solution were injected in the midline of the vaginal
      wall prior to each incision line.

      By utilizing the 10 cm Visual-analogue-scale (VAS) we examined the differences in
      post-operative pain at rest at 3, 8, and 24 hours, and during ambulation at 8 and 24 hours
      using multivariate linear regression models. We also assessed the differences in analgesics
      given at the different time points between the groups using multivariate negative binomial
      regression models.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Drug group versus placebo group
primary purpose: Supportive Care
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: The surgeons, the pain assessing researchers, and the participating women will all be blinded to what the syringes contain.
measure: Pain at movement
time frame: 24 hours
description: Movement-evoked pain will be scored after the operation
measure: pain at rest
time frame: 24 hours
description: Pain at rest will be scored with the woman lying in bed after the operation
arm group label: Study
arm group type: Active Comparator
description: Marcaine 0.5 % Injectable Solution will be injected before incision, and in a systematic fashion as a modified paracervical block. First, 2 ml will be injected through the vaginal fornices at 03.00, 06.00, 09.00, and 12.00 hours at 2 cm depth. Thus, 8 ml will be systematically injected around the cervical circumference before incision. In addition, 1 ml of the solution will be injected in each resection line (sacro-uterine and cardinal ligaments), adding up to a total of 10 ml. In case of performing additional anterior/ posterior colporrhaphy, additional solution of Marcaine 0.25%will be prepared: 5 ml of the solution will be injected to the cutting line of the anterior/ posterior vaginal wall, respectively, prior to incision.
arm group label: Control
arm group type: Placebo Comparator
description: Sodium Chloride 0.9% will be injected before incision, and in a systematic fashion as a modified paracervical block. First, 2 ml will be injected through the vaginal fornices at 03.00, 06.00, 09.00, and 12.00 hours at 2 cm depth. Thus, 8 ml will be systematically injected around the cervical circumference before incision. In addition, 1 ml of the solution will be injected in each resection line (sacro-uterine and cardinal ligaments), adding up to a total of 10 ml. In case of performing additional anterior/ posterior colporrhaphy, additional solution of Sodium Chloride 0.9% will be prepared: 5 ml of the solution will be injected to the cutting line of the anterior/ posterior vaginal wall, respectively, prior to incision.
intervention type: Drug
intervention name: Marcaine 0.5 % Injectable Solution
description: Local infiltration by Marcaine 0.5% Injectable Solution prior to incision
arm group label: Study
other name: Study
intervention type: Drug
intervention name: Sodium Chloride 0.9%
description: Local infiltration by Sodium Chloride 0.9% prior to incision
arm group label: Control
other name: Placebo
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Shimon Ginat, MD
role: Study Director
affiliation: Wolfson Medical Center
facility: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Wolfson Medical Center
investigator full name: Ohad Gluck
investigator title: OBGYN resident
mesh term: Pain, Postoperative
mesh term: Bupivacaine
sharing ipd: No