<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/NCT04443569</url>
  </required_header>
  <id_info>
    <org_study_id>2000028500</org_study_id>
    <nct_id>NCT04443569</nct_id>
  </id_info>
  <brief_title>Lidocaine Patches After Cesarean Section</brief_title>
  <acronym>LPACS</acronym>
  <official_title>Lidocaine Patches After Cesarean Section</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yale University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to investigate the impact of using lidocaine patches after cesarean&#xD;
      section on pain control and opioid use in the immediate post-operative period. The hypothesis&#xD;
      is the use of lidocaine patches in the immediate post-operative period will lead to a&#xD;
      decrease in the use of opioids as pain control compared to patients that do not have a&#xD;
      lidocaine patch in place. Additionally, the a decrease in the visual analog pain score&#xD;
      compared to women who do not use a lidocaine patch in the immediate post-operative period&#xD;
      following cesarean delivery is anticipated.&#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.[1] There is one study that reports decreased immediate postoperative&#xD;
      pain when lidocaine patches were placed at laparoscopic port sites following gynecologic&#xD;
      surgery as measured by visual analog scale score and the Prince Henry and 5-point verbal&#xD;
      rating pain scale . [2] There have been no studies looking at the impact of lidocaine patches&#xD;
      in obstetric surgical procedures, specifically cesarean sections.&#xD;
&#xD;
      Cesarean sections are one of the most common surgeries in the United States. Following&#xD;
      cesarean sections it is common to utilize opioids in the hospital and upon discharge to&#xD;
      manage patient's post-operative pain. According to the CDC overdose deaths involving&#xD;
      prescription opioids were five times higher in 2017 than in 1999 with over 200,000 deaths.[3]&#xD;
      This creates an opportunity to decrease the use of post-operative opioids with the&#xD;
      application of a lidocaine patch as an adjunctive post-operative pain management modality&#xD;
      following cesarean sections.&#xD;
&#xD;
      Lidocaine patches are a common topical analgesia therapy used for localized pain control in&#xD;
      the inpatient and outpatient setting. It's use in the postoperative period is less understood&#xD;
      and the use of topical lidocaine patches has not been thoroughly investigated in the surgical&#xD;
      literature. Thus far, it has been shown as an effective therapy at laparoscopic port sites&#xD;
      following laparoscopic appendectomies. [4] It's use in obstetrical surgeries has not been&#xD;
      studied. Overall, the limited research on this topic making it a valuable area of research.&#xD;
&#xD;
      This study will involve prospective enrollment of women undergoing cesarean deliveries. Women&#xD;
      will be randomized to receive a lidocaine patch or no lidocaine patch to be worn for 72 hours&#xD;
      after delivery to help manage postoperative pain. This will be an adjunctive therapy in&#xD;
      addition to the parental and oral narcotic pain medication that is routine prescribed. The&#xD;
      utility of lidocaine patches for management of post-cesarean delivery pain will be assess by&#xD;
      2 measures. The first measure will involve the total daily dose of narcotic used in morphine&#xD;
      equivalent doses. The second outcome assessed will be subjective pain as measured on a 1-10&#xD;
      scale and reported by the patients to nursing staff. This score will be averaged for each 24&#xD;
      hour period post-operatively.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 10, 2021</start_date>
  <completion_date type="Anticipated">May 31, 2023</completion_date>
  <primary_completion_date type="Actual">August 31, 2022</primary_completion_date>
  <phase>Phase 3</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>This will be a prospective randomized non-blinded controlled trial. All cesarean sections for women undergoing their first or second cesarean delivery will be included. Patients will be approached and consented during the pre-operative period when presenting for scheduled surgery or at the time of consent for a non-scheduled cesarean section. The lidocaine patch would be placed on the superior-lateral aspect of the Pfannenstiel incision in the PACU prior to being transferred to the postpartum floor.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Outcomes assessor/statistician will not be made aware of the treatment group of the patients.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Narcotic use</measure>
    <time_frame>the first 72 hours post-operative</time_frame>
    <description>The primary outcome of this study would be the total amount of narcotic, or opioid, medication that a patient receives calculated in morphine equivalents</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subjective Pain</measure>
    <time_frame>the first 72 hours post-operative</time_frame>
    <description>daily pain scores conducted by the nursing staff every morning and prior to medication administration. This will be a repeated measure using the subjective 0-10 pain scale. The scores will be averaged over each 24 hour (day) period and then compared</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Postoperative Pain</condition>
  <condition>Obstetric Pain</condition>
  <condition>Opioid Use</condition>
  <arm_group>
    <arm_group_label>Lidocaine Patch Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will be women who were randomized to receive a lidocaine patch for postoperative pain following cesarean delivery in addition to routine postoperative pain management.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This group will be women randomized to routine postoperative pain management following cesarean delivery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lidocaine patch</intervention_name>
    <description>Lidocaine patch to be placed in post-operative recovery area and used in addition to routine post-cesarean delivery pain management</description>
    <arm_group_label>Lidocaine Patch Group</arm_group_label>
  </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>52 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Audrey Merriam, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistant Professor; Assistant Professor, Department of Obstetrics, Gynecology and Reproductive Sciences</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Christopher Arkfeld, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yale New Haven Hospital</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06512</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://casereports.bmj.com/content/2011/bcr.06.2010.3074</url>
    <description>Related Info</description>
  </link>
  <link>
    <url>http://doi.org/10.1089/lap.2018.0013</url>
    <description>Related Info</description>
  </link>
  <reference>
    <citation>Gilhooly D, McGarvey B, O'Mahony H, O'Connor TC. Topical lidocaine patch 5% for acute postoperative pain control. BMJ Case Rep. 2011 Feb 8;2011:bcr0620103074. doi: 10.1136/bcr.06.2010.3074.</citation>
    <PMID>22715181</PMID>
  </reference>
  <reference>
    <citation>Kwon YS, Kim JB, Jung HJ, Koo YJ, Lee IH, Im KT, Woo JS, Im KS. Treatment for postoperative wound pain in gynecologic laparoscopic surgery: topical lidocaine patches. J Laparoendosc Adv Surg Tech A. 2012 Sep;22(7):668-73. doi: 10.1089/lap.2011.0440. Epub 2012 Aug 3.</citation>
    <PMID>22861076</PMID>
  </reference>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>November 9, 2022</last_update_submitted>
  <last_update_submitted_qc>November 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Labor Pain</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>
  <pending_results>
    <submitted>August 25, 2023</submitted>
  </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/NCT04443569
org study id: 2000028500
nct id: NCT04443569
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The aim of this study is to investigate the impact of using lidocaine patches after cesarean
      section on pain control and opioid use in the immediate post-operative period. The hypothesis
      is the use of lidocaine patches in the immediate post-operative period will lead to a
      decrease in the use of opioids as pain control compared to patients that do not have a
      lidocaine patch in place. Additionally, the a decrease in the visual analog pain score
      compared to women who do not use a lidocaine patch in the immediate post-operative period
      following cesarean delivery is anticipated.
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.[1] 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 . [2] There have been no studies looking at the impact of lidocaine patches
      in obstetric surgical procedures, specifically cesarean sections.

      Cesarean sections are one of the most common surgeries in the United States. Following
      cesarean sections it is common to utilize opioids in the hospital and upon discharge to
      manage patient's post-operative pain. According to the CDC overdose deaths involving
      prescription opioids were five times higher in 2017 than in 1999 with over 200,000 deaths.[3]
      This creates an opportunity to decrease the use of post-operative opioids with the
      application of a lidocaine patch as an adjunctive post-operative pain management modality
      following cesarean sections.

      Lidocaine patches are a common topical analgesia therapy used for localized pain control in
      the inpatient and outpatient setting. It's use in the postoperative period is less understood
      and the use of topical lidocaine patches has not been thoroughly investigated in the surgical
      literature. Thus far, it has been shown as an effective therapy at laparoscopic port sites
      following laparoscopic appendectomies. [4] It's use in obstetrical surgeries has not been
      studied. Overall, the limited research on this topic making it a valuable area of research.

      This study will involve prospective enrollment of women undergoing cesarean deliveries. Women
      will be randomized to receive a lidocaine patch or no lidocaine patch to be worn for 72 hours
      after delivery to help manage postoperative pain. This will be an adjunctive therapy in
      addition to the parental and oral narcotic pain medication that is routine prescribed. The
      utility of lidocaine patches for management of post-cesarean delivery pain will be assess by
      2 measures. The first measure will involve the total daily dose of narcotic used in morphine
      equivalent doses. The second outcome assessed will be subjective pain as measured on a 1-10
      scale and reported by the patients to nursing staff. This score will be averaged for each 24
      hour period post-operatively.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This will be a prospective randomized non-blinded controlled trial. All cesarean sections for women undergoing their first or second cesarean delivery will be included. Patients will be approached and consented during the pre-operative period when presenting for scheduled surgery or at the time of consent for a non-scheduled cesarean section. The lidocaine patch would be placed on the superior-lateral aspect of the Pfannenstiel incision in the PACU prior to being transferred to the postpartum floor.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Outcomes assessor/statistician will not be made aware of the treatment group of the patients.
measure: Narcotic use
time frame: the first 72 hours post-operative
description: The primary outcome of this study would be the total amount of narcotic, or opioid, medication that a patient receives calculated in morphine equivalents
measure: Subjective Pain
time frame: the first 72 hours post-operative
description: daily pain scores conducted by the nursing staff every morning and prior to medication administration. This will be a repeated measure using the subjective 0-10 pain scale. The scores will be averaged over each 24 hour (day) period and then compared
arm group label: Lidocaine Patch Group
arm group type: Experimental
description: This group will be women who were randomized to receive a lidocaine patch for postoperative pain following cesarean delivery in addition to routine postoperative pain management.
arm group label: Control Group
arm group type: No Intervention
description: This group will be women randomized to routine postoperative pain management following cesarean delivery.
intervention type: Drug
intervention name: Lidocaine patch
description: Lidocaine patch to be placed in post-operative recovery area and used in addition to routine post-cesarean delivery pain management
arm group label: Lidocaine Patch Group
criteria: 
gender: Female
gender based: Yes
gender description: Patients need to be pregnant and undergoing a cesarean delivery
minimum age: 18 Years
maximum age: 52 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Audrey Merriam, MD, MS
role: Principal Investigator
affiliation: Assistant Professor; Assistant Professor, Department of Obstetrics, Gynecology and Reproductive Sciences
last name: Christopher Arkfeld, MD
role: Principal Investigator
affiliation: Yale University
facility: 
country: United States
url: https://casereports.bmj.com/content/2011/bcr.06.2010.3074
description: Related Info
url: http://doi.org/10.1089/lap.2018.0013
description: Related Info
citation: Gilhooly D, McGarvey B, O'Mahony H, O'Connor TC. Topical lidocaine patch 5% for acute postoperative pain control. BMJ Case Rep. 2011 Feb 8;2011:bcr0620103074. doi: 10.1136/bcr.06.2010.3074.
PMID: 22715181
citation: Kwon YS, Kim JB, Jung HJ, Koo YJ, Lee IH, Im KT, Woo JS, Im KS. Treatment for postoperative wound pain in gynecologic laparoscopic surgery: topical lidocaine patches. J Laparoendosc Adv Surg Tech A. 2012 Sep;22(7):668-73. doi: 10.1089/lap.2011.0440. Epub 2012 Aug 3.
PMID: 22861076
responsible party type: Sponsor
mesh term: Labor Pain
mesh term: Lidocaine
sharing ipd: No
submitted: August 25, 2023