<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/NCT02257255</url>
  </required_header>
  <id_info>
    <org_study_id>cesarean</org_study_id>
    <nct_id>NCT02257255</nct_id>
  </id_info>
  <brief_title>Classic Cesarean Section Versus Minimally Invasive Cesarean Section: Pain Assessment</brief_title>
  <official_title>Classic Cesarean Section Versus Minimally Invasive Cesarean Section: Pain Assessment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade do Vale do Sapucai</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade do Vale do Sapucai</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cesarean section is the most performed abdominal surgery in women, worldwide. The World&#xD;
      Health Organization (WHO) considers 15% of deliveries the ideal rate of this surgery.&#xD;
      However, Brazil presents the highest rates of cesarian section in the world, reaching 85% in&#xD;
      hospitals and private clinics.&#xD;
&#xD;
      The most used technique of cesarean section is the known as Pfannenstiel or Classical&#xD;
      technique. In 1996, a new technique was described, called Misgav Ladach or minimally invasive&#xD;
      technique.&#xD;
&#xD;
      Several studies have show that the minimally invasive technique is faster and promotes lower&#xD;
      costs and less intraoperative bleeding. There is no current evidence that this technique is&#xD;
      less painful.&#xD;
&#xD;
      This study aims to compare the postoperative pain in both techniques,by means of two pain&#xD;
      scales: a one-dimensional scale, the Visual Analogue Scale, and a multidimensional scale, the&#xD;
      McGill Scale.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. STUDY&#xD;
&#xD;
           Primary, clinical, prospective, randomized, double blind with, controlled, two parallel&#xD;
           groups interventional and analytical.&#xD;
&#xD;
        2. MATERIAL&#xD;
&#xD;
      A-CALCULATION OF SAMPLE SIZE&#xD;
&#xD;
      Were used to calculate the size of the sample study data Antalon et al. (2001), who also&#xD;
      compared the two techniques of caesarean section, and the Student's t-test was used bi flow.&#xD;
      Considering a standard deviation of 1.5 points in the Visual Analog Pain Scale, and&#xD;
      significant a difference of two points, the calculated number of patients per group was 15,&#xD;
      with a significance level of 5% and power of 95 test %.&#xD;
&#xD;
      C RANDOMIZATION AND CONFIDENTIALITY OF ALLOCATION&#xD;
&#xD;
      The allocation will be determined by random sequence generated by computer (BioStat 5.0&#xD;
      software, Mamiraua Institute, Brazil). The sequence had been held by the researcher who will&#xD;
      make allocation of patients to groups in caesarean Pfannenstiel or Misgav-Ladach, 15 in each&#xD;
      group.&#xD;
&#xD;
      D-PROCEDURES&#xD;
&#xD;
      ANESTHESIA:&#xD;
&#xD;
      In both groups will be performed spinal anesthesia at L2-L4 with heavy bupivacaine 13 mg and&#xD;
      morphine 0.1 mg% standardized by the Anesthesiology Service of HCSL.&#xD;
&#xD;
      SURGICAL PROCEDURE:&#xD;
&#xD;
      Surgical procedure (classical technique)&#xD;
&#xD;
      Once displayed, according to the behavior of the service, this will be performed according to&#xD;
      the following surgical technique:&#xD;
&#xD;
        -  Traditional Preparation: pubic shaving, prior bladder emptying.&#xD;
&#xD;
        -  Asepsis with degerminate clorhexidine and alcoholic&#xD;
&#xD;
        -  The transverse abdominal incision approximately 10 cm, 3-4 cm above the pubic symphysis.&#xD;
&#xD;
        -  Cross Opening subcutaneous tissue.&#xD;
&#xD;
        -  Opening Aponeurosis transversely, hemostasis of bleeding vessels.&#xD;
&#xD;
        -  Separation by dissection of the anterior rectus sheath muscles of the abdomen to the&#xD;
           umbilicus.&#xD;
&#xD;
        -  Separation of the muscles of the median raphe manually, exposure, clamping and opening&#xD;
           the parietal peritoneum with scissors longitudinally.&#xD;
&#xD;
        -  Opening of the visceral peritoneum transversely with scissors, taking off the bladder&#xD;
           from the uterus.&#xD;
&#xD;
        -  Hysterotomy segment transverse, arcuate, superior concavity, made a small incision with&#xD;
           a scalpel and that is complete with Kelly forceps to reach the uterine cavity and then&#xD;
           enlarging it with fingers without taking off the bladder from the uterus.&#xD;
&#xD;
        -  Disposal of amniotic fluid. fetal extraction, using the leverage if necessary.&#xD;
&#xD;
        -  Clamping of the umbilical cord and immediate care to the newborn.&#xD;
&#xD;
        -  Administration of cefazolin 2g IV and 10 IU oxytocin.&#xD;
&#xD;
        -  Afterbirth and revision of the uterine cavity.&#xD;
&#xD;
        -  Hysterorrhaphy with Catgut chrome one in a continuous suture not anchored.&#xD;
&#xD;
        -  Visceral peritonization simple catgut and 2-0 suture in simple running suture.&#xD;
&#xD;
        -  Revision of the abdominal cavity.&#xD;
&#xD;
        -  Closure of the parietal peritoneum and with simple catgut 2-0 suture in simple running&#xD;
           suture.&#xD;
&#xD;
        -  Closing the muscular plane is separated into &quot;U&quot;, with simple catgut fioa 2-0 points.&#xD;
&#xD;
        -  Closing the aponeurosis chrome catgut sutures in one not anchored.&#xD;
&#xD;
        -  Approximation of the subcutaneous tissue with 2-0 catgut simple in separate points.&#xD;
&#xD;
        -  Skin closure is made with nylon suture with 4-0 points Donati modified.&#xD;
&#xD;
        -  Dressing kept simple in the early hours.&#xD;
&#xD;
      Surgery (minimally invasive technique)&#xD;
&#xD;
      Once displayed, according to the behavior of the service, this will be performed according to&#xD;
      the following surgical technique:&#xD;
&#xD;
        -  Traditional Preparation: pubic shaving, prior bladder emptying.&#xD;
&#xD;
        -  Asepsis and degermante with alcoholic chlorhexidine.&#xD;
&#xD;
        -  The transverse abdominal incision approximately 10 cm, 3-4 cm above the pubic symphysis.&#xD;
&#xD;
        -  Cross Opening subcutaneous tissue with electrocautery used in clotting.&#xD;
&#xD;
        -  Opening Aponeurosis transversely, hemostasis of bleeding vessels.&#xD;
&#xD;
        -  Separation of the Muscles of the median raphe manually, exposure, clamping the parietal&#xD;
           peritoneum, small opening with scissors. Through digital dilatation peritoneum is opened&#xD;
           across the entire length of the incision.&#xD;
&#xD;
        -  Hysterotomies Segment transverse, arcuate, superior concavity, made a small incision&#xD;
           with a scalpel and that is complete with Kelly forceps to reach the uterine cavity and&#xD;
           then enlarging it with fingers without taking off the bladder from the uterus.&#xD;
&#xD;
        -  Disposal of amniotic fluid. Fetal extraction, using the leverage if necessary.&#xD;
&#xD;
        -  Clamping of the umbilical cord and immediate care to the newborn.&#xD;
&#xD;
        -  Administration of cefazolin 1 g IV and 10 IU oxytocin.&#xD;
&#xD;
        -  And revision of the uterine cavity.&#xD;
&#xD;
        -  Hysterorrhaphy with Catgut chrome one in a continuous suture not anchored.&#xD;
&#xD;
        -  Revision of the abdominal cavity.&#xD;
&#xD;
        -  Closing the aponeurosis chrome catgut sutures in one not anchored.&#xD;
&#xD;
        -  Approximation of the subcutaneous tissue with 2-0 catgut simple in separate points.&#xD;
&#xD;
        -  Skin closure is made with nylon suture with 4-0 points Donati modified.&#xD;
&#xD;
        -  Dressing kept simple in the early hours]. Postoperative medication&#xD;
&#xD;
        -  Intravenous hydration with 1000 ml of glucose 5% and 500 ml of 0.9% saline solution in&#xD;
           drip 60 drops / minute.&#xD;
&#xD;
        -  Use (dimethicone) every 8 hours the first dose at 12 hours postoperatively.&#xD;
&#xD;
        -  Use of analgesic and anti-spasmodic every 6 hours if needed (Buscopan composts®&#xD;
           (scopolamine butylbromide 20mg and dipyrone 2.5 mg).&#xD;
&#xD;
      F-STATISTICAL METHOD The data will be tabulated and subjected to statistical analysis. The&#xD;
      level of rejection of the null hypothesis will be set at 5% (α &lt;0.05).&#xD;
&#xD;
      For numeric variables will be used descriptive statistics, with calculations of median, mean&#xD;
      and deviation padrão.O Mann-Whitney test is used to compare two independent groups with&#xD;
      nonparametric behavior and the chi-square test for categorical variables.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2014</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</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>Supportive Care</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain</measure>
    <time_frame>Postoperative 24 hours</time_frame>
    <description>pain assessment using two kinds of pain scales VAS and McGILL scale at 6, 12 and 24 hours of postoperative</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>time spent in two different techniques for cesarean</measure>
    <time_frame>1 hour</time_frame>
    <description>compare time spent in each technique, considering only cesarean that spent less than 1 hour</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Pregnancy</condition>
  <arm_group>
    <arm_group_label>Pfannenstiel cesarean section</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Women in 36 to 40 weeks of pregnancy undergoing first cesarean section by Pfannenstiel technique. Pain assessment on postoperative hours 6, 12 and 24.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Misgav-Ladach cesarean section</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Women in 36 to 40 weeks of pregnancy undergoing first cesarean section by minimally invasive technique. Pain assessment on postoperative hours 6, 12 and 24.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Pfannenstiel cesarean section</intervention_name>
    <description>Pain scales ( VAS and McGill ) 6, 12 and 24 hours after cesarean to pain assessment</description>
    <arm_group_label>Pfannenstiel cesarean section</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Misgav-Ladach cesarean section</intervention_name>
    <description>Pain scales (VAS and McGill) 6, 12 and 24 hours ater cesarean to pain assessment</description>
    <arm_group_label>Misgav-Ladach cesarean section</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        INCLUSION CRITERIA:&#xD;
&#xD;
          -  Primiparous patients who are undergoing cesarean section&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
          -  Previous pelvic and/or abdominal surgery ;&#xD;
&#xD;
          -  Emergency cesarean section, due to placenta previa, fetal distress, cord prolapse or&#xD;
             other obstetric emergencies;&#xD;
&#xD;
          -  Pregnancies below 36 weeks.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>IVANILDO ARCHANGELO</last_name>
    <role>Principal Investigator</role>
    <affiliation>UNIVERSIDADE DO VALE DO SAPUCAÍ</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Daniela F Veiga, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Universidade do Vale do Sapucaí</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ivanildo Archangelo Jr</name>
      <address>
        <city>Pouso Alegre</city>
        <state>Minas Gerais</state>
        <zip>37550-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>August 18, 2014</study_first_submitted>
  <study_first_submitted_qc>October 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 6, 2014</study_first_posted>
  <last_update_submitted>May 27, 2015</last_update_submitted>
  <last_update_submitted_qc>May 27, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 28, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade do Vale do Sapucai</investigator_affiliation>
    <investigator_full_name>Ivanildo Archangelo Junior</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>cesarean section</keyword>
  <keyword>pain, postoperative/diagnosis</keyword>
  <keyword>pain measurement/methods</keyword>
  <!-- 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/NCT02257255
org study id: cesarean
nct id: NCT02257255
lead sponsor: 
has dmc: No
Cesarean section is the most performed abdominal surgery in women, worldwide. The World
      Health Organization (WHO) considers 15% of deliveries the ideal rate of this surgery.
      However, Brazil presents the highest rates of cesarian section in the world, reaching 85% in
      hospitals and private clinics.

      The most used technique of cesarean section is the known as Pfannenstiel or Classical
      technique. In 1996, a new technique was described, called Misgav Ladach or minimally invasive
      technique.

      Several studies have show that the minimally invasive technique is faster and promotes lower
      costs and less intraoperative bleeding. There is no current evidence that this technique is
      less painful.

      This study aims to compare the postoperative pain in both techniques,by means of two pain
      scales: a one-dimensional scale, the Visual Analogue Scale, and a multidimensional scale, the
      McGill Scale.
1. STUDY

           Primary, clinical, prospective, randomized, double blind with, controlled, two parallel
           groups interventional and analytical.

        2. MATERIAL

      A-CALCULATION OF SAMPLE SIZE

      Were used to calculate the size of the sample study data Antalon et al. (2001), who also
      compared the two techniques of caesarean section, and the Student's t-test was used bi flow.
      Considering a standard deviation of 1.5 points in the Visual Analog Pain Scale, and
      significant a difference of two points, the calculated number of patients per group was 15,
      with a significance level of 5% and power of 95 test %.

      C RANDOMIZATION AND CONFIDENTIALITY OF ALLOCATION

      The allocation will be determined by random sequence generated by computer (BioStat 5.0
      software, Mamiraua Institute, Brazil). The sequence had been held by the researcher who will
      make allocation of patients to groups in caesarean Pfannenstiel or Misgav-Ladach, 15 in each
      group.

      D-PROCEDURES

      ANESTHESIA:

      In both groups will be performed spinal anesthesia at L2-L4 with heavy bupivacaine 13 mg and
      morphine 0.1 mg% standardized by the Anesthesiology Service of HCSL.

      SURGICAL PROCEDURE:

      Surgical procedure (classical technique)

      Once displayed, according to the behavior of the service, this will be performed according to
      the following surgical technique:

        -  Traditional Preparation: pubic shaving, prior bladder emptying.

        -  Asepsis with degerminate clorhexidine and alcoholic

        -  The transverse abdominal incision approximately 10 cm, 3-4 cm above the pubic symphysis.

        -  Cross Opening subcutaneous tissue.

        -  Opening Aponeurosis transversely, hemostasis of bleeding vessels.

        -  Separation by dissection of the anterior rectus sheath muscles of the abdomen to the
           umbilicus.

        -  Separation of the muscles of the median raphe manually, exposure, clamping and opening
           the parietal peritoneum with scissors longitudinally.

        -  Opening of the visceral peritoneum transversely with scissors, taking off the bladder
           from the uterus.

        -  Hysterotomy segment transverse, arcuate, superior concavity, made a small incision with
           a scalpel and that is complete with Kelly forceps to reach the uterine cavity and then
           enlarging it with fingers without taking off the bladder from the uterus.

        -  Disposal of amniotic fluid. fetal extraction, using the leverage if necessary.

        -  Clamping of the umbilical cord and immediate care to the newborn.

        -  Administration of cefazolin 2g IV and 10 IU oxytocin.

        -  Afterbirth and revision of the uterine cavity.

        -  Hysterorrhaphy with Catgut chrome one in a continuous suture not anchored.

        -  Visceral peritonization simple catgut and 2-0 suture in simple running suture.

        -  Revision of the abdominal cavity.

        -  Closure of the parietal peritoneum and with simple catgut 2-0 suture in simple running
           suture.

        -  Closing the muscular plane is separated into "U", with simple catgut fioa 2-0 points.

        -  Closing the aponeurosis chrome catgut sutures in one not anchored.

        -  Approximation of the subcutaneous tissue with 2-0 catgut simple in separate points.

        -  Skin closure is made with nylon suture with 4-0 points Donati modified.

        -  Dressing kept simple in the early hours.

      Surgery (minimally invasive technique)

      Once displayed, according to the behavior of the service, this will be performed according to
      the following surgical technique:

        -  Traditional Preparation: pubic shaving, prior bladder emptying.

        -  Asepsis and degermante with alcoholic chlorhexidine.

        -  The transverse abdominal incision approximately 10 cm, 3-4 cm above the pubic symphysis.

        -  Cross Opening subcutaneous tissue with electrocautery used in clotting.

        -  Opening Aponeurosis transversely, hemostasis of bleeding vessels.

        -  Separation of the Muscles of the median raphe manually, exposure, clamping the parietal
           peritoneum, small opening with scissors. Through digital dilatation peritoneum is opened
           across the entire length of the incision.

        -  Hysterotomies Segment transverse, arcuate, superior concavity, made a small incision
           with a scalpel and that is complete with Kelly forceps to reach the uterine cavity and
           then enlarging it with fingers without taking off the bladder from the uterus.

        -  Disposal of amniotic fluid. Fetal extraction, using the leverage if necessary.

        -  Clamping of the umbilical cord and immediate care to the newborn.

        -  Administration of cefazolin 1 g IV and 10 IU oxytocin.

        -  And revision of the uterine cavity.

        -  Hysterorrhaphy with Catgut chrome one in a continuous suture not anchored.

        -  Revision of the abdominal cavity.

        -  Closing the aponeurosis chrome catgut sutures in one not anchored.

        -  Approximation of the subcutaneous tissue with 2-0 catgut simple in separate points.

        -  Skin closure is made with nylon suture with 4-0 points Donati modified.

        -  Dressing kept simple in the early hours]. Postoperative medication

        -  Intravenous hydration with 1000 ml of glucose 5% and 500 ml of 0.9% saline solution in
           drip 60 drops / minute.

        -  Use (dimethicone) every 8 hours the first dose at 12 hours postoperatively.

        -  Use of analgesic and anti-spasmodic every 6 hours if needed (Buscopan composts®
           (scopolamine butylbromide 20mg and dipyrone 2.5 mg).

      F-STATISTICAL METHOD The data will be tabulated and subjected to statistical analysis. The
      level of rejection of the null hypothesis will be set at 5% (α <0.05).

      For numeric variables will be used descriptive statistics, with calculations of median, mean
      and deviation padrão.O Mann-Whitney test is used to compare two independent groups with
      nonparametric behavior and the chi-square test for categorical variables.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Pain
time frame: Postoperative 24 hours
description: pain assessment using two kinds of pain scales VAS and McGILL scale at 6, 12 and 24 hours of postoperative
measure: time spent in two different techniques for cesarean
time frame: 1 hour
description: compare time spent in each technique, considering only cesarean that spent less than 1 hour
arm group label: Pfannenstiel cesarean section
arm group type: Active Comparator
description: Women in 36 to 40 weeks of pregnancy undergoing first cesarean section by Pfannenstiel technique. Pain assessment on postoperative hours 6, 12 and 24.
arm group label: Misgav-Ladach cesarean section
arm group type: Experimental
description: Women in 36 to 40 weeks of pregnancy undergoing first cesarean section by minimally invasive technique. Pain assessment on postoperative hours 6, 12 and 24.
intervention type: Procedure
intervention name: Pfannenstiel cesarean section
description: Pain scales ( VAS and McGill ) 6, 12 and 24 hours after cesarean to pain assessment
arm group label: Pfannenstiel cesarean section
intervention type: Procedure
intervention name: Misgav-Ladach cesarean section
description: Pain scales (VAS and McGill) 6, 12 and 24 hours ater cesarean to pain assessment
arm group label: Misgav-Ladach cesarean section
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: IVANILDO ARCHANGELO
role: Principal Investigator
affiliation: UNIVERSIDADE DO VALE DO SAPUCAÍ
last name: Daniela F Veiga, MD, PhD
role: Study Chair
affiliation: Universidade do Vale do Sapucaí
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Universidade do Vale do Sapucai
investigator full name: Ivanildo Archangelo Junior
investigator title: MD