xml: <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/NCT05972681</url>
    </required_header>
    <id_info>
      <org_study_id>2023-14825</org_study_id>
      <nct_id>NCT05972681</nct_id>
    </id_info>
    <brief_title>The PAIN (Pelvic Area Injection for Numbness) Study</brief_title>
    <official_title>A Randomized Controlled Trial of Bupivacaine for Local Pain Control Following Perineal Laceration Repair in Patients With Pre-existing Epidural Analgesia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Montefiore Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Montefiore 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>
    </oversight_info>
    <brief_summary>
      <textblock>
        The prevalence of perineal lacerations is more than 75% of all vaginal deliveries. The repair&#xD;
        of such lacerations in our institution is usually done using lidocaine for non-epiduralized&#xD;
        patients versus no local injection in patients with a pre-existing epidural analgesia. The&#xD;
        prevalence of epidural analgesia use among women who underwent vaginal delivery in&#xD;
        cross-sectional study of over 2 million deliveries in the United States was 71.1%. Once the&#xD;
        analgesic effect of the epidural analgesia fades, the laceration may cause uncontrolled&#xD;
        postpartum pain which can affect both the physical and mental recovery period, extend&#xD;
        hospital stays, and increase the potential for serious adverse reactions with pain&#xD;
        medications.&#xD;
  &#xD;
        The research hypothesis of this study is that adding a locally injected analgesic, which will&#xD;
        take effect once the epidural analgesia fades, may alleviate perineal pain and improve&#xD;
        women's overall well-being and satisfaction.&#xD;
  &#xD;
        The proposed trial is a two-arm, single-masked, prospective randomized superiority control&#xD;
        trial. Women with a working epidural analgesia, and status post a vaginal delivery involving&#xD;
        a second-degree laceration will be invited to participate. Women in the local anesthesia (LA)&#xD;
        arm will get a LA injected to the laceration and women in the sham arm will get an injection&#xD;
        with saline. The differences in perineal pain between the groups will be evaluated at time of&#xD;
        the first analgesic (TFA) demand, maternal satisfaction at 24 hours, and visual analog scale&#xD;
        (VAS) pain score.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">September 2024</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>Time to first analgesic</measure>
      <time_frame>Up to 24 hours after perineal laceration</time_frame>
      <description>Average time to first analgesic (TFA) will be evaluated per patient as the duration interval following injection to administration of the first analgesic, as applicable.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Maternal Satisfaction</measure>
      <time_frame>24 hours after perineal laceration</time_frame>
      <description>Maternal satisfaction will be assessed by participants' rating their ability to carry out their daily living activities at 24hrs using a 4-point scale (very poor; poor; good; or very good)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pain score after injection at perineal laceration</measure>
      <time_frame>Immediately and 24 hours after perineal laceration</time_frame>
      <description>Participants will self-report measures of symptoms using the Visual Analog Scale (VAS) to determine acute and chronic pain. Participants record a single handwritten mark at one point along the length of a 10-cm line that represents a continuum between the two ends of a scale where &quot;no pain&quot; is on the left end (0 cm) of the scale and the &quot;worst pain&quot; is on the right end of the scale (10 cm). Measurements from the starting point (left end) of the scale to the patients' marks are recorded in centimeters and are interpreted as the intensity of pain. The values will be used to track pain progression for a patient and to compare pain between patients with similar conditions</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Vaginal Laceration During Delivery</condition>
    <arm_group>
      <arm_group_label>Bupivacaine with epinephrine arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Normal saline sham arm</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Bupivacaine with epinephrine arm</intervention_name>
      <description>Women in the bupivacaine with epinephrine arm will get 10 milliliters (ml) of bupivacaine with epinephrine injected to the vaginal laceration site.</description>
      <arm_group_label>Bupivacaine with epinephrine arm</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Sham normal saline arm</intervention_name>
      <description>Women in the sham normal saline arm will get 10 milliliter (ml) of normal saline injected to the vaginal laceration site.</description>
      <arm_group_label>Normal saline sham arm</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  &gt;= 18 years old&#xD;
  &#xD;
            -  Healthy with a singleton pregnancy&#xD;
  &#xD;
            -  English or Spanish speaking&#xD;
  &#xD;
            -  Ability to consent for themselves&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Women who underwent an operative vaginal delivery and whose vaginal delivery was&#xD;
               complicated by a postpartum hemorrhage&#xD;
  &#xD;
            -  Multiple gestation&#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_contact>
      <last_name>Clarissa P Diniz, MD</last_name>
      <phone>718-904-2767</phone>
      <email>cdiniz@montefiore.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Fatima Estrada, MD</last_name>
      <phone>718-904-2767</phone>
      <email>festrada@montefiore.org</email>
    </overall_contact_backup>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 17, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</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>Lacerations</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Epinephrine</mesh_term>
      <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>
  
  
text: 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/NCT05972681
  org study id: 2023-14825
  nct id: NCT05972681
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The prevalence of perineal lacerations is more than 75% of all vaginal deliveries. The repair
        of such lacerations in our institution is usually done using lidocaine for non-epiduralized
        patients versus no local injection in patients with a pre-existing epidural analgesia. The
        prevalence of epidural analgesia use among women who underwent vaginal delivery in
        cross-sectional study of over 2 million deliveries in the United States was 71.1%. Once the
        analgesic effect of the epidural analgesia fades, the laceration may cause uncontrolled
        postpartum pain which can affect both the physical and mental recovery period, extend
        hospital stays, and increase the potential for serious adverse reactions with pain
        medications.
  
        The research hypothesis of this study is that adding a locally injected analgesic, which will
        take effect once the epidural analgesia fades, may alleviate perineal pain and improve
        women's overall well-being and satisfaction.
  
        The proposed trial is a two-arm, single-masked, prospective randomized superiority control
        trial. Women with a working epidural analgesia, and status post a vaginal delivery involving
        a second-degree laceration will be invited to participate. Women in the local anesthesia (LA)
        arm will get a LA injected to the laceration and women in the sham arm will get an injection
        with saline. The differences in perineal pain between the groups will be evaluated at time of
        the first analgesic (TFA) demand, maternal satisfaction at 24 hours, and visual analog scale
        (VAS) pain score.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Time to first analgesic
  time frame: Up to 24 hours after perineal laceration
  description: Average time to first analgesic (TFA) will be evaluated per patient as the duration interval following injection to administration of the first analgesic, as applicable.
  measure: Maternal Satisfaction
  time frame: 24 hours after perineal laceration
  description: Maternal satisfaction will be assessed by participants' rating their ability to carry out their daily living activities at 24hrs using a 4-point scale (very poor; poor; good; or very good)
  measure: Pain score after injection at perineal laceration
  time frame: Immediately and 24 hours after perineal laceration
  description: Participants will self-report measures of symptoms using the Visual Analog Scale (VAS) to determine acute and chronic pain. Participants record a single handwritten mark at one point along the length of a 10-cm line that represents a continuum between the two ends of a scale where "no pain" is on the left end (0 cm) of the scale and the "worst pain" is on the right end of the scale (10 cm). Measurements from the starting point (left end) of the scale to the patients' marks are recorded in centimeters and are interpreted as the intensity of pain. The values will be used to track pain progression for a patient and to compare pain between patients with similar conditions
  arm group label: Bupivacaine with epinephrine arm
  arm group type: Experimental
  arm group label: Normal saline sham arm
  arm group type: Sham Comparator
  intervention type: Drug
  intervention name: Bupivacaine with epinephrine arm
  description: Women in the bupivacaine with epinephrine arm will get 10 milliliters (ml) of bupivacaine with epinephrine injected to the vaginal laceration site.
  arm group label: Bupivacaine with epinephrine arm
  intervention type: Other
  intervention name: Sham normal saline arm
  description: Women in the sham normal saline arm will get 10 milliliter (ml) of normal saline injected to the vaginal laceration site.
  arm group label: Normal saline sham arm
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Clarissa P Diniz, MD
  phone: 718-904-2767
  email: cdiniz@montefiore.org
  last name: Fatima Estrada, MD
  phone: 718-904-2767
  email: festrada@montefiore.org
  responsible party type: Sponsor
  mesh term: Lacerations
  mesh term: Epinephrine
  mesh term: Bupivacaine
  sharing ipd: No