<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/NCT04506034</url>
  </required_header>
  <id_info>
    <org_study_id>aswu/277/7/18</org_study_id>
    <nct_id>NCT04506034</nct_id>
  </id_info>
  <brief_title>Lidocaine Patch Versus Intravenous Lidocaine in Pain Relief After Laparoscopy</brief_title>
  <official_title>Is Lidocaine Patch as Effective as Intravenous Lidocaine in Pain and Illus Reduction After Laparoscopic Gynecologic Surgery? A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aswan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aswan University 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 evaluate the efficacy of lidocaine patch applied around wound in laparoscopic gynecologic&#xD;
      surgery in reduction of postoperative pain and illus compared to intravenous lidocaine&#xD;
      infusion and placebo.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Postoperative pain after gynecologic surgery is a challenging problem associated with&#xD;
      increased morbidity and cost. The inflammatory response to surgery plays a crucial rule in&#xD;
      inducing postoperative illus. Systemic local anesthetics proved to have anti-inflammatory&#xD;
      properties that may be beneficial in preventing ileus added to its analgesic actions. The&#xD;
      lidocaine patch evaluated in many types of pain with promising results. The study try to&#xD;
      evaluate the patch in perioperative field as a more simple and safe technique than the&#xD;
      intravenous route.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2020</start_date>
  <completion_date type="Anticipated">September 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">August 30, 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>
    <intervention_model_description>randomized controlled trial</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>randomized controlled trial</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Pain VAS scores at rest and during coughing were recorded postoperatively</measure>
    <time_frame>24 hours</time_frame>
    <description>To determine if lidocaine patch is superior to placebo as an adjunctive therapy for acute postoperative pain. Average pain score in women at 24 hours postoperatively. Measured using a Visual Analog Scale (VAS), a scale which measures pain from 0 to 100 with 0=&quot;no pain&quot; and 100=&quot;the worst pain you have ever felt&quot;.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Infertility</condition>
  <arm_group>
    <arm_group_label>lidocaine patches</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>for every port entry site from the three in ports of laparoscope, patients received three lidocaine patches 5% (Lidoderm® , Endo Pharmaceuticals, Chadds Ford, PA). Each patch measured 10 cm × 14 cm and contains (700 mg), was divided into two equal parts, six parts applied two of it around one port entry site that marked before sterilization and just before induction of anesthesia. The patches not changed until removed after return of bowel function or on the maximum at fifth postoperative day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IV lidocaine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>received i.v. lidocaine infusion after induction of anesthesia, 2 mg/min if body weight &gt;70 kg or 1 mg/min if body weight &lt;70 kg.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IV saline infusion</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>received i.v. saline infusion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>lidocaine patches</intervention_name>
    <description>for every port entry site from the three in ports of laparoscope, patients received three lidocaine patches 5% (Lidoderm® , Endo Pharmaceuticals, Chadds Ford, PA). Each patch measured 10 cm × 14 cm and contains (700 mg), was divided into two equal parts, six parts applied two of it around one port entry site that marked before sterilization and just before induction of anesthesia. The patches not changed until removed after return of bowel function or on the maximum at fifth postoperative day.</description>
    <arm_group_label>lidocaine patches</arm_group_label>
    <other_name>lidocaine patch</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IV lidocaine</intervention_name>
    <description>received i.v. lidocaine infusion after induction of anesthesia, 2 mg/min if body weight &gt;70 kg or 1 mg/min if body weight &lt;70 kg.</description>
    <arm_group_label>IV lidocaine</arm_group_label>
    <other_name>lidocaine infusion</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IV saline infusion</intervention_name>
    <description>received i.v. saline infusion.</description>
    <arm_group_label>IV saline infusion</arm_group_label>
    <other_name>placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  female undergoing elective gynecologic surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  known allergy to lidocaine,&#xD;
&#xD;
          -  respiratory or cardiac dysfunction, arrhythmia, treatment with antiarrhythmic drugs,&#xD;
&#xD;
          -  inflammatory bowel disease (Crohn's disease or ulcerative colitis)&#xD;
&#xD;
          -  hepatic, renal&#xD;
&#xD;
          -  chronic use of analgesics or corticosteroids&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>female for laparoscopic gynecology</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>nahla w Shady, md</last_name>
    <role>Study Chair</role>
    <affiliation>Aswan universirty</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>hany f Sallam, md</last_name>
    <phone>+20102435461</phone>
    <phone_ext>002</phone_ext>
    <email>hany.farouk@aswu.edu.eg</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>nahla w Shady, md</last_name>
    <phone>+201022336052</phone>
    <phone_ext>002</phone_ext>
    <email>hanygyne@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Aswan University Hospital</name>
      <address>
        <city>Aswan</city>
        <zip>81528</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 6, 2020</study_first_submitted>
  <study_first_submitted_qc>August 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>August 7, 2020</last_update_submitted>
  <last_update_submitted_qc>August 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aswan University Hospital</investigator_affiliation>
    <investigator_full_name>hany farouk</investigator_full_name>
    <investigator_title>A Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</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/NCT04506034
org study id: aswu/277/7/18
nct id: NCT04506034
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To evaluate the efficacy of lidocaine patch applied around wound in laparoscopic gynecologic
      surgery in reduction of postoperative pain and illus compared to intravenous lidocaine
      infusion and placebo.
Postoperative pain after gynecologic surgery is a challenging problem associated with
      increased morbidity and cost. The inflammatory response to surgery plays a crucial rule in
      inducing postoperative illus. Systemic local anesthetics proved to have anti-inflammatory
      properties that may be beneficial in preventing ileus added to its analgesic actions. The
      lidocaine patch evaluated in many types of pain with promising results. The study try to
      evaluate the patch in perioperative field as a more simple and safe technique than the
      intravenous route.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: randomized controlled trial
primary purpose: Prevention
masking: Single (Participant)
masking description: randomized controlled trial
measure: Pain VAS scores at rest and during coughing were recorded postoperatively
time frame: 24 hours
description: To determine if lidocaine patch is superior to placebo as an adjunctive therapy for acute postoperative pain. Average pain score in women at 24 hours postoperatively. Measured using a Visual Analog Scale (VAS), a scale which measures pain from 0 to 100 with 0="no pain" and 100="the worst pain you have ever felt".
arm group label: lidocaine patches
arm group type: Experimental
description: for every port entry site from the three in ports of laparoscope, patients received three lidocaine patches 5% (Lidoderm® , Endo Pharmaceuticals, Chadds Ford, PA). Each patch measured 10 cm × 14 cm and contains (700 mg), was divided into two equal parts, six parts applied two of it around one port entry site that marked before sterilization and just before induction of anesthesia. The patches not changed until removed after return of bowel function or on the maximum at fifth postoperative day.
arm group label: IV lidocaine
arm group type: Active Comparator
description: received i.v. lidocaine infusion after induction of anesthesia, 2 mg/min if body weight >70 kg or 1 mg/min if body weight <70 kg.
arm group label: IV saline infusion
arm group type: Placebo Comparator
description: received i.v. saline infusion.
intervention type: Drug
intervention name: lidocaine patches
description: for every port entry site from the three in ports of laparoscope, patients received three lidocaine patches 5% (Lidoderm® , Endo Pharmaceuticals, Chadds Ford, PA). Each patch measured 10 cm × 14 cm and contains (700 mg), was divided into two equal parts, six parts applied two of it around one port entry site that marked before sterilization and just before induction of anesthesia. The patches not changed until removed after return of bowel function or on the maximum at fifth postoperative day.
arm group label: lidocaine patches
other name: lidocaine patch
intervention type: Drug
intervention name: IV lidocaine
description: received i.v. lidocaine infusion after induction of anesthesia, 2 mg/min if body weight >70 kg or 1 mg/min if body weight <70 kg.
arm group label: IV lidocaine
other name: lidocaine infusion
intervention type: Drug
intervention name: IV saline infusion
description: received i.v. saline infusion.
arm group label: IV saline infusion
other name: placebo
criteria: 
gender: Female
gender based: Yes
gender description: female for laparoscopic gynecology
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: nahla w Shady, md
role: Study Chair
affiliation: Aswan universirty
last name: hany f Sallam, md
phone: +20102435461
phone ext: 002
email: hany.farouk@aswu.edu.eg
last name: nahla w Shady, md
phone: +201022336052
phone ext: 002
email: hanygyne@yahoo.com
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Aswan University Hospital
investigator full name: hany farouk
investigator title: A Professor
mesh term: Infertility
mesh term: Lidocaine
sharing ipd: No