<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/NCT04505644</url>
  </required_header>
  <id_info>
    <org_study_id>aswu/279/6/18</org_study_id>
    <nct_id>NCT04505644</nct_id>
  </id_info>
  <brief_title>Lidocaine Patch Versus Intravenous Lidocaine in Pain Relief After Cesarean Section</brief_title>
  <official_title>Is Lidocaine Patch as Effective as Intravenous Lidocaine in Pain and Illus Reduction After Cesarean Section? 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 reduction of&#xD;
      postoperative pain and illus compared to intravenous lidocaine infusion and placebo after&#xD;
      cesarean section.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The use of lidocaine as a local anesthetic is a common and widely used in practice. Lidocaine&#xD;
      patches can be used for localized pain control and can be placed every 24 hours. The use of&#xD;
      lidocaine patches in post-operative patients has been reported in one case report in&#xD;
      obstetric literature. There is one study that reports decreased immediate postoperative pain&#xD;
      when lidocaine patches were placed at laparoscopic port sites following gynecologic surgery&#xD;
      as measured by visual analog scale score and the Prince Henry and 5-point verbal rating pain&#xD;
      scale . There have been no studies looking at the impact of lidocaine patches in obstetric&#xD;
      surgical procedures, specifically cesarean sections.&#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">May 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">March 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>double blind randomized controlled study</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>double blind randomized controlled study</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Total dose of opioids received in the first 24 hours following Cesarean</measure>
    <time_frame>24 hours</time_frame>
    <description>The total dose of opioids received in the first 24 hours following Cesarean delivery measured as oral morphine equivalents. This total dose will be calculated for every subject in the study, and the average and standard deviation (or appropriate non-parametric values if the data is not normally distributed) will be compared between the subjects randomized to the intervention arm and the placebo arm of the study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Post-operative pain score at 24 hours post-operatively</measure>
    <time_frame>24 hours</time_frame>
    <description>Assessment of pain using visual analog scale 0-10, 0 = minimum and 10 = maximum scores</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of complications of lidocaine use</measure>
    <time_frame>72 hours</time_frame>
    <description>Complications of lidocaine use include local burning, nausea, dizziness, drowsiness, serious skin reactions such as blistering, confusion, blurred vision, ringing in the ears, and allergies and hypersensitivities.&#xD;
Definition: Patient reported side effects which will be reported as frequencies of occurrence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Return of bowel function</measure>
    <time_frame>72 hours</time_frame>
    <description>Return of bowel function (measured in hours from completion of surgery to passage of flatus) Measured in hours from completion of surgery to passage of flatus. This will be reported as a continuous variable for the number of hours following surgery to flatus</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">180</enrollment>
  <condition>Cesarean Section Complications</condition>
  <arm_group>
    <arm_group_label>lidocaine patch</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>5% lidocaine patch applied at 12 hours after cesarean delivery and removed 24 hours after delivery. A second 5% lidocaine patch applied at 36 hours after cesarean delivery and removed at 48 hours after delivery.</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 +Sham patch</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>received i.v. saline infusion +Sham patch containing no study medication applied at 12 hours after cesarean delivery and removed 24 hours after delivery. A second sham patch containing no study medication applied at 36 hours after cesarean delivery and removed at 48 hours after delivery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>lidocaine patch</intervention_name>
    <description>Sham patch containing no study medication applied at 12 hours after cesarean delivery and removed 24 hours after delivery. A second sham patch containing no study medication applied at 36 hours after cesarean delivery and removed at 48 hours after delivery.</description>
    <arm_group_label>lidocaine patch</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>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IV saline infusion +Sham patch</intervention_name>
    <description>received i.v. saline infusion +Sham patch containing no study medication applied at 12 hours after cesarean delivery and removed 24 hours after delivery. A second sham patch containing no study medication applied at 36 hours after cesarean delivery and removed at 48 hours after delivery.</description>
    <arm_group_label>IV saline infusion +Sham patch</arm_group_label>
    <other_name>placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  Primary or secondary cesarean delivery&#xD;
&#xD;
          -  Able to consent to research study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  3 or more prior cesarean deliveries&#xD;
&#xD;
          -  History of abdominoplasty&#xD;
&#xD;
          -  History of abdominal hernia repair with mesh&#xD;
&#xD;
          -  Allergy to lidocaine&#xD;
&#xD;
          -  Allergy to adhesives in medical tape&#xD;
&#xD;
          -  Women who received general anesthesia for their cesarean delivery&#xD;
&#xD;
          -  Women with active substance abuse&#xD;
&#xD;
          -  Women methadone or suboxone for a history of opiate abuse&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Patients need to be pregnant and undergoing a cesarean delivery</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>
  <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 6, 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 11, 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>
  <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/NCT04505644
org study id: aswu/279/6/18
nct id: NCT04505644
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 reduction of
      postoperative pain and illus compared to intravenous lidocaine infusion and placebo after
      cesarean section.
The use of lidocaine as a local anesthetic is a common and widely used in practice. Lidocaine
      patches can be used for localized pain control and can be placed every 24 hours. The use of
      lidocaine patches in post-operative patients has been reported in one case report in
      obstetric literature. There is one study that reports decreased immediate postoperative pain
      when lidocaine patches were placed at laparoscopic port sites following gynecologic surgery
      as measured by visual analog scale score and the Prince Henry and 5-point verbal rating pain
      scale . There have been no studies looking at the impact of lidocaine patches in obstetric
      surgical procedures, specifically cesarean sections.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: double blind randomized controlled study
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: double blind randomized controlled study
measure: Total dose of opioids received in the first 24 hours following Cesarean
time frame: 24 hours
description: The total dose of opioids received in the first 24 hours following Cesarean delivery measured as oral morphine equivalents. This total dose will be calculated for every subject in the study, and the average and standard deviation (or appropriate non-parametric values if the data is not normally distributed) will be compared between the subjects randomized to the intervention arm and the placebo arm of the study.
measure: Post-operative pain score at 24 hours post-operatively
time frame: 24 hours
description: Assessment of pain using visual analog scale 0-10, 0 = minimum and 10 = maximum scores
measure: Incidence of complications of lidocaine use
time frame: 72 hours
description: Complications of lidocaine use include local burning, nausea, dizziness, drowsiness, serious skin reactions such as blistering, confusion, blurred vision, ringing in the ears, and allergies and hypersensitivities.
Definition: Patient reported side effects which will be reported as frequencies of occurrence
measure: Return of bowel function
time frame: 72 hours
description: Return of bowel function (measured in hours from completion of surgery to passage of flatus) Measured in hours from completion of surgery to passage of flatus. This will be reported as a continuous variable for the number of hours following surgery to flatus
arm group label: lidocaine patch
arm group type: Experimental
description: 5% lidocaine patch applied at 12 hours after cesarean delivery and removed 24 hours after delivery. A second 5% lidocaine patch applied at 36 hours after cesarean delivery and removed at 48 hours after delivery.
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 +Sham patch
arm group type: Placebo Comparator
description: received i.v. saline infusion +Sham patch containing no study medication applied at 12 hours after cesarean delivery and removed 24 hours after delivery. A second sham patch containing no study medication applied at 36 hours after cesarean delivery and removed at 48 hours after delivery.
intervention type: Drug
intervention name: lidocaine patch
description: Sham patch containing no study medication applied at 12 hours after cesarean delivery and removed 24 hours after delivery. A second sham patch containing no study medication applied at 36 hours after cesarean delivery and removed at 48 hours after delivery.
arm group label: lidocaine patch
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
intervention type: Drug
intervention name: IV saline infusion +Sham patch
description: received i.v. saline infusion +Sham patch containing no study medication applied at 12 hours after cesarean delivery and removed 24 hours after delivery. A second sham patch containing no study medication applied at 36 hours after cesarean delivery and removed at 48 hours after delivery.
arm group label: IV saline infusion +Sham patch
other name: placebo
criteria: 
gender: Female
gender based: Yes
gender description: Patients need to be pregnant and undergoing a cesarean delivery
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
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Aswan University Hospital
investigator full name: hany farouk
investigator title: A Professor
mesh term: Lidocaine
sharing ipd: No