<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/NCT03264586</url>
  </required_header>
  <id_info>
    <org_study_id>9</org_study_id>
    <nct_id>NCT03264586</nct_id>
  </id_info>
  <brief_title>The Effect of Lidocaine - Prilocaine Cream (EMLA) Versus Mepivacaine Infiltration on Pain Relief During And After Mediolateral Episiotomies</brief_title>
  <official_title>The Effect of Lidocaine - Prilocaine Cream (EMLA) Versus Mepivacaine Infiltration on Pain Relief During And After Mediolateral Episiotomies: A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</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>
      Included women were divided randomly into two groups:&#xD;
&#xD;
      Group A: (n=100): women were subjected to application of EMLA® cream &quot;Lidocaine-prilocaine&#xD;
      cream (EMLAcream; Astra Zeneca, Basiglio, Italy is an entectic mixture of 2.5% lidocaine and&#xD;
      2.5% prilocaine)&quot;for pain relief during episiotomy repair.&#xD;
&#xD;
      Group B: (n=100): women were subjected to application of local injection of 10 ml of 1%&#xD;
      mepivacaine for pain relief during episiotomy repair.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      During the second stage of labor, women were placed in the lithotomy position. 10- Patients&#xD;
      who were enrolled in the study were guaranteed to obtain additional anesthesia during&#xD;
      episiotomy repair whenever pain exceeded the tolerability threshold.&#xD;
&#xD;
      11- Volunteers were assigned randomly to have either local injection of 10 ml of 1%&#xD;
      mepivacaine or application of 5gm-dose® EMLA cream&quot;Lidocaine- prilocaine cream(EMLA cream;&#xD;
      Astra Zeneca, Basiglio, Italy is an entectic mixture of 2.5% lidocaine and 2.5% prilocaine)&quot;&#xD;
      for pain relief during episiotomy repair.&#xD;
&#xD;
        1. Group A: &quot;EMLA group&quot;&#xD;
&#xD;
             -  Women who were assigned randomly to receive EMLA cream had a 5gm dose of cream&#xD;
                applied to the intact surface of the perineum and area covered with an occlusive&#xD;
                dressing to facilitate pemetration thrug stratum corneum&#xD;
&#xD;
             -  EMLA cream was applied, 1 hour before the expected time of birth.&#xD;
&#xD;
             -  With the assistance at birth, the residue of cream was removed to prevent contact&#xD;
                with the fetus, because sodium hydroxide, which is a component of the cream, can&#xD;
                cause fetal eye irritation.&#xD;
&#xD;
             -  No additional anesthetic was applied if episiotomy was necessary.&#xD;
&#xD;
             -  Before commancement of perineal repair any residual cream was wiped off.&#xD;
&#xD;
        2. Group B: &quot;mepivacaine infiltration group&quot;.&#xD;
&#xD;
             -  In the mepivacaine group, 10 ml of 1% mepivacaine solution was injected slowly when&#xD;
                the fetal head was crowned with frequent aspiration to avoid intravascular&#xD;
                injection.&#xD;
&#xD;
             -  In the mepivacaine group, if an episiotomy was indicated, it was performed after&#xD;
                infiltration of perineal tissue with 10 ml of 1% mepivacaine solution.&#xD;
&#xD;
             -  The suture procedure was delayed 10 minutes after the injection of the aneathetic&#xD;
&#xD;
             -  All episiotomies were performed at the top of contraction as mediolateral&#xD;
                episiotomies.&#xD;
&#xD;
                12- Episiotomy repair&#xD;
&#xD;
             -  In all cases episiotomies was repaired with a loose, continous, non locking suture&#xD;
                to close the vaginal mucosa and the muscular layer of the perineum using vicryl&#xD;
                Number zero (0).&#xD;
&#xD;
             -  The suture begins about 0.5 cms above the apex of the vaginal wound The suture are&#xD;
                evenly placed to allow for approximation of the edges of the wound without causing&#xD;
                tension or wrinkling or over lapping.&#xD;
&#xD;
             -  At the end of the vaginal mucosal repair care is taken to align the edges of the&#xD;
                episiotomy wound to restore the appearance of the hymenal ring, the fourchette and&#xD;
                the beginning of the perineal skin.&#xD;
&#xD;
             -  At the point where perineal skin begins; the suture is then passed beneath the&#xD;
                vaginal mucosa, and repair of perineal muscle begins. The deep layer of muscles is&#xD;
                closed first, ensuring no dead space one left behind, and ensuring no bleeding&#xD;
                points are ignored.&#xD;
&#xD;
             -  The skin was closed with the same continuous suture to approximate the subcutinuous&#xD;
                tissue.&#xD;
&#xD;
             -  The wound is cleared with antiseptic solution and covered by addressing. 14- Before&#xD;
                leaving the delivery suite (approximately 2 hours after delivery) each patient was&#xD;
                asked to record the severity of pain that she had experienced during perineal&#xD;
                repair in a 10-cm visual analog scale, where 0 cm means no pain and 10 cm means&#xD;
                unbearable pain.&#xD;
&#xD;
             -  The patient was asked to mark the point that best indicated the perception of her&#xD;
                pain on the visual analog scale&#xD;
&#xD;
             -  Finally, women were asked to express their overall satisfaction with the anesthesia&#xD;
                method during perineal repair with &quot;yes&quot; or &quot;no&quot; answers&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 2017</start_date>
  <completion_date type="Anticipated">March 2018</completion_date>
  <primary_completion_date type="Anticipated">March 2018</primary_completion_date>
  <phase>Phase 4</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>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>pain</measure>
    <time_frame>24 hours after delivery</time_frame>
    <description>The patient was asked to mark the point that best indicated the perception of her pain on the visual analog scale</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Episiotomy Pain</condition>
  <arm_group>
    <arm_group_label>Lidocaine-prilocaine cream</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Women who were assigned randomly to receive EMLA cream had a 5gm dose of cream applied to the intact surface of the perineum and area covered with an occlusive dressing to facilitate pemetration thrug stratum corneum&#xD;
EMLA cream was applied, 1 hour before the expected time of birth.&#xD;
With the assistance at birth, the residue of cream was removed to prevent contact with the fetus, because sodium hydroxide, which is a component of the cream, can cause fetal eye irritation.&#xD;
No additional anesthetic was applied if episiotomy was necessary.&#xD;
Before commancement of perineal repair any residual cream was wiped off.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>mepivacaine infiltration group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In the mepivacaine group, 10 ml of 1% mepivacaine solution was injected slowly when the fetal head was crowned with frequent aspiration to avoid intravascular injection.&#xD;
In the mepivacaine group, if an episiotomy was indicated, it was performed after infiltration of perineal tissue with 10 ml of 1% mepivacaine solution.&#xD;
The suture procedure was delayed 10 minutes after the injection of the aneathetic</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lidocaine-prilocaine cream</intervention_name>
    <description>5gm dose of cream applied to the intact surface of the perineum and area covered with an occlusive dressing to facilitate penetration&#xD;
- EMLA cream was applied, 1 hour before the expected time of birth.</description>
    <arm_group_label>Lidocaine-prilocaine cream</arm_group_label>
    <other_name>EMLA cream</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>mepivacaine infiltration group</intervention_name>
    <description>10 ml of 1% mepivacaine solution was injected slowly when the fetal head was crowned with frequent aspiration to avoid intravascular injection.&#xD;
In the mepivacaine group, if an episiotomy was indicated, it was performed after infiltration of perineal tissue with 10 ml of 1% mepivacaine solution.&#xD;
The suture procedure was delayed 10 minutes after the injection of the aneathetic</description>
    <arm_group_label>mepivacaine infiltration group</arm_group_label>
    <other_name>1% mepivacaine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>mediolateral episiotomy</intervention_name>
    <description>Episiotomy repair a loose, continous, non locking suture to close the vaginal mucosa and the muscular layer of the perineum using vicryl Number zero (0).&#xD;
At the end of the vaginal mucosal repair care is taken to align the edges of the episiotomy wound&#xD;
At the point where perineal skin begins; the suture is then passed beneath the vaginal mucosa, and repair of perineal muscle begins. The deep layer of muscles is closed first, ensuring no dead space one left behind&#xD;
The skin was closed with the same continuous suture to approximate the subcutinuous tissue.</description>
    <arm_group_label>Lidocaine-prilocaine cream</arm_group_label>
    <arm_group_label>mepivacaine infiltration group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Gestational age 37 weeks or more&#xD;
&#xD;
          2. Singleton gestation.&#xD;
&#xD;
          3. Uncomplicated pregnancy.&#xD;
&#xD;
          4. Vertex presentation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Epidural analgesia request.&#xD;
&#xD;
          2. Operative delivery.&#xD;
&#xD;
          3. No other methods are used for pain control 2hours befor episiotomy&#xD;
&#xD;
          4. Previous adverse reaction to local anesthetic.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>39 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmed Maged, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>kasr Alainy medical school</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ahmed Maged, MD</last_name>
    <phone>01005227404</phone>
    <email>prof.ahmedmaged@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ahmed Abd ElHak, MD</last_name>
    <email>ah.abdelhak73@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Kasr Alainy medical school</name>
      <address>
        <city>Cairo</city>
        <zip>12151</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>August 25, 2017</last_update_submitted>
  <last_update_submitted_qc>August 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Ahmed Maged</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
    <mesh_term>Prilocaine</mesh_term>
    <mesh_term>Mepivacaine</mesh_term>
    <mesh_term>Lidocaine, Prilocaine Drug Combination</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03264586
org study id: 9
nct id: NCT03264586
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Included women were divided randomly into two groups:

      Group A: (n=100): women were subjected to application of EMLA® cream "Lidocaine-prilocaine
      cream (EMLAcream; Astra Zeneca, Basiglio, Italy is an entectic mixture of 2.5% lidocaine and
      2.5% prilocaine)"for pain relief during episiotomy repair.

      Group B: (n=100): women were subjected to application of local injection of 10 ml of 1%
      mepivacaine for pain relief during episiotomy repair.
During the second stage of labor, women were placed in the lithotomy position. 10- Patients
      who were enrolled in the study were guaranteed to obtain additional anesthesia during
      episiotomy repair whenever pain exceeded the tolerability threshold.

      11- Volunteers were assigned randomly to have either local injection of 10 ml of 1%
      mepivacaine or application of 5gm-dose® EMLA cream"Lidocaine- prilocaine cream(EMLA cream;
      Astra Zeneca, Basiglio, Italy is an entectic mixture of 2.5% lidocaine and 2.5% prilocaine)"
      for pain relief during episiotomy repair.

        1. Group A: "EMLA group"

             -  Women who were assigned randomly to receive EMLA cream had a 5gm dose of cream
                applied to the intact surface of the perineum and area covered with an occlusive
                dressing to facilitate pemetration thrug stratum corneum

             -  EMLA cream was applied, 1 hour before the expected time of birth.

             -  With the assistance at birth, the residue of cream was removed to prevent contact
                with the fetus, because sodium hydroxide, which is a component of the cream, can
                cause fetal eye irritation.

             -  No additional anesthetic was applied if episiotomy was necessary.

             -  Before commancement of perineal repair any residual cream was wiped off.

        2. Group B: "mepivacaine infiltration group".

             -  In the mepivacaine group, 10 ml of 1% mepivacaine solution was injected slowly when
                the fetal head was crowned with frequent aspiration to avoid intravascular
                injection.

             -  In the mepivacaine group, if an episiotomy was indicated, it was performed after
                infiltration of perineal tissue with 10 ml of 1% mepivacaine solution.

             -  The suture procedure was delayed 10 minutes after the injection of the aneathetic

             -  All episiotomies were performed at the top of contraction as mediolateral
                episiotomies.

                12- Episiotomy repair

             -  In all cases episiotomies was repaired with a loose, continous, non locking suture
                to close the vaginal mucosa and the muscular layer of the perineum using vicryl
                Number zero (0).

             -  The suture begins about 0.5 cms above the apex of the vaginal wound The suture are
                evenly placed to allow for approximation of the edges of the wound without causing
                tension or wrinkling or over lapping.

             -  At the end of the vaginal mucosal repair care is taken to align the edges of the
                episiotomy wound to restore the appearance of the hymenal ring, the fourchette and
                the beginning of the perineal skin.

             -  At the point where perineal skin begins; the suture is then passed beneath the
                vaginal mucosa, and repair of perineal muscle begins. The deep layer of muscles is
                closed first, ensuring no dead space one left behind, and ensuring no bleeding
                points are ignored.

             -  The skin was closed with the same continuous suture to approximate the subcutinuous
                tissue.

             -  The wound is cleared with antiseptic solution and covered by addressing. 14- Before
                leaving the delivery suite (approximately 2 hours after delivery) each patient was
                asked to record the severity of pain that she had experienced during perineal
                repair in a 10-cm visual analog scale, where 0 cm means no pain and 10 cm means
                unbearable pain.

             -  The patient was asked to mark the point that best indicated the perception of her
                pain on the visual analog scale

             -  Finally, women were asked to express their overall satisfaction with the anesthesia
                method during perineal repair with "yes" or "no" answers
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: pain
time frame: 24 hours after delivery
description: The patient was asked to mark the point that best indicated the perception of her pain on the visual analog scale
arm group label: Lidocaine-prilocaine cream
arm group type: Active Comparator
description: Women who were assigned randomly to receive EMLA cream had a 5gm dose of cream applied to the intact surface of the perineum and area covered with an occlusive dressing to facilitate pemetration thrug stratum corneum
EMLA cream was applied, 1 hour before the expected time of birth.
With the assistance at birth, the residue of cream was removed to prevent contact with the fetus, because sodium hydroxide, which is a component of the cream, can cause fetal eye irritation.
No additional anesthetic was applied if episiotomy was necessary.
Before commancement of perineal repair any residual cream was wiped off.
arm group label: mepivacaine infiltration group
arm group type: Active Comparator
description: In the mepivacaine group, 10 ml of 1% mepivacaine solution was injected slowly when the fetal head was crowned with frequent aspiration to avoid intravascular injection.
In the mepivacaine group, if an episiotomy was indicated, it was performed after infiltration of perineal tissue with 10 ml of 1% mepivacaine solution.
The suture procedure was delayed 10 minutes after the injection of the aneathetic
intervention type: Drug
intervention name: Lidocaine-prilocaine cream
description: 5gm dose of cream applied to the intact surface of the perineum and area covered with an occlusive dressing to facilitate penetration
- EMLA cream was applied, 1 hour before the expected time of birth.
arm group label: Lidocaine-prilocaine cream
other name: EMLA cream
intervention type: Drug
intervention name: mepivacaine infiltration group
description: 10 ml of 1% mepivacaine solution was injected slowly when the fetal head was crowned with frequent aspiration to avoid intravascular injection.
In the mepivacaine group, if an episiotomy was indicated, it was performed after infiltration of perineal tissue with 10 ml of 1% mepivacaine solution.
The suture procedure was delayed 10 minutes after the injection of the aneathetic
arm group label: mepivacaine infiltration group
other name: 1% mepivacaine
intervention type: Procedure
intervention name: mediolateral episiotomy
description: Episiotomy repair a loose, continous, non locking suture to close the vaginal mucosa and the muscular layer of the perineum using vicryl Number zero (0).
At the end of the vaginal mucosal repair care is taken to align the edges of the episiotomy wound
At the point where perineal skin begins; the suture is then passed beneath the vaginal mucosa, and repair of perineal muscle begins. The deep layer of muscles is closed first, ensuring no dead space one left behind
The skin was closed with the same continuous suture to approximate the subcutinuous tissue.
arm group label: Lidocaine-prilocaine cream
arm group label: mepivacaine infiltration group
criteria: 
gender: Female
gender based: Yes
minimum age: 19 Years
maximum age: 39 Years
healthy volunteers: No
last name: Ahmed Maged, MD
role: Principal Investigator
affiliation: kasr Alainy medical school
last name: Ahmed Maged, MD
phone: 01005227404
email: prof.ahmedmaged@gmail.com
last name: Ahmed Abd ElHak, MD
email: ah.abdelhak73@gmail.com
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Ahmed Maged
investigator title: Professor
mesh term: Lidocaine
mesh term: Prilocaine
mesh term: Mepivacaine
mesh term: Lidocaine, Prilocaine Drug Combination