<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/NCT03811067</url>
  </required_header>
  <id_info>
    <org_study_id>KAEK 2017/348</org_study_id>
    <nct_id>NCT03811067</nct_id>
  </id_info>
  <brief_title>Transversus Abdominis Plane Block Versus Rectus Sheath Block After Cesarean Delivery</brief_title>
  <official_title>Transversus Abdominis Plane Block Versus Rectus Sheath Block for Postoperative Pain After Cesarean Delivery: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kocaeli University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kocaeli University</source>
  <oversight_info>
    <has_dmc>No</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>
      Importance of effective postoperative pain management is well known. The undesired effects of&#xD;
      pain can be prevented with multimodal analgesia for the patient. Overall, for cesarean&#xD;
      delivery, interaction between the mother and her newborn baby can be provided earlier. Many&#xD;
      regional anesthesia techniques can be prefferred after cesarean delivery. Aim of the study is&#xD;
      to compare the postoperative analgesia effects of transversus abdominis plane block and&#xD;
      rectus sheath block after elective cesarean delivery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 25, 2019</start_date>
  <completion_date type="Actual">July 15, 2019</completion_date>
  <primary_completion_date type="Actual">July 1, 2019</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>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Morphine consumption</measure>
    <time_frame>Postoperative 24th hour.</time_frame>
    <description>Morphine consumption (mg) of patients with patient controlled device</description>
  </primary_outcome>
  <primary_outcome>
    <measure>NRS score</measure>
    <time_frame>Postoperative 24th hour</time_frame>
    <description>Numerating rating scale of patients</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>TAP group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Transversus abdominis plane block administered group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RS group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Rectus sheath block administered group</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Transversus abdominis plane block</intervention_name>
    <description>Transversus abdominis plane block will be performed bilaterally after the surgery.</description>
    <arm_group_label>TAP group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Rectus sheath block</intervention_name>
    <description>Rectus sheath block will be performed bilaterally after the surgery.</description>
    <arm_group_label>RS group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        ASA I-II patients Patients undergo elective cesarean delivery Gestation period between&#xD;
        37-40 weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        obesity (body mass index &gt;35 kg/m2) infection of the skin at the site of needle puncture&#xD;
        area patients with known allergies to any of the study drugs coagulopathy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hadi Ufuk MD Yörükoğlu</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kocaeli University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kocaeli University</name>
      <address>
        <city>Kocaeli</city>
        <zip>41350</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>January 18, 2019</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>July 22, 2019</last_update_submitted>
  <last_update_submitted_qc>July 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kocaeli University</investigator_affiliation>
    <investigator_full_name>Hadi Ufuk Yörükoğlu</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>Postoperative pain</keyword>
  <keyword>Transversus abdominis plane block</keyword>
  <keyword>Rectus sheath block</keyword>
  <keyword>Cesarean delivery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_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/NCT03811067
org study id: KAEK 2017/348
nct id: NCT03811067
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Importance of effective postoperative pain management is well known. The undesired effects of
      pain can be prevented with multimodal analgesia for the patient. Overall, for cesarean
      delivery, interaction between the mother and her newborn baby can be provided earlier. Many
      regional anesthesia techniques can be prefferred after cesarean delivery. Aim of the study is
      to compare the postoperative analgesia effects of transversus abdominis plane block and
      rectus sheath block after elective cesarean delivery.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Morphine consumption
time frame: Postoperative 24th hour.
description: Morphine consumption (mg) of patients with patient controlled device
measure: NRS score
time frame: Postoperative 24th hour
description: Numerating rating scale of patients
arm group label: Control group
arm group type: No Intervention
arm group label: TAP group
arm group type: Active Comparator
description: Transversus abdominis plane block administered group
arm group label: RS group
arm group type: Active Comparator
description: Rectus sheath block administered group
intervention type: Procedure
intervention name: Transversus abdominis plane block
description: Transversus abdominis plane block will be performed bilaterally after the surgery.
arm group label: TAP group
intervention type: Procedure
intervention name: Rectus sheath block
description: Rectus sheath block will be performed bilaterally after the surgery.
arm group label: RS group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Hadi Ufuk MD Yörükoğlu
role: Principal Investigator
affiliation: Kocaeli University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Kocaeli University
investigator full name: Hadi Ufuk Yörükoğlu
investigator title: Principal investigator
mesh term: Pain, Postoperative
sharing ipd: No