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/NCT05999981</url>
    </required_header>
    <id_info>
      <org_study_id>MSKU 13-IV</org_study_id>
      <nct_id>NCT05999981</nct_id>
    </id_info>
    <brief_title>Comparison of the Quality of Recovery After Cesarean Section Surgery</brief_title>
    <official_title>Comparison Between Ultrasound Guided Transversalis Fascia Plane Block and Transversus Abdominis Plane Block on Postoperative Recovery in Patients Undergoing Cesarean Section Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Muğla Sıtkı Koçman University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Muğla Sıtkı Koçman 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>
        Inadequate pain control after cesarean section surgery causes postpartum depression,&#xD;
        persistent pain and delayed mother-infant bonding. The investigator's aim is to asses whether&#xD;
        ultrasound guided transversalis fascia plane block (TFPB) or transversus abdominis plane&#xD;
        (TAP) block would improve postoperative quality of recovery and decrease postoperative opioid&#xD;
        consumption after cesarean section surgery.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 24, 2023</start_date>
    <completion_date type="Anticipated">November 2, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 1, 2023</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>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Postoperative quality of recovery</measure>
      <time_frame>Postoperative 24th hour</time_frame>
      <description>Postoperative quality of recovery will be assessed by Obstetric Quality of Recovery 11 Turkish (ObsQoR-11T) score</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Postoperative opioid consumption</measure>
      <time_frame>Postoperative 1st, 2nd, 4th, 8th 12th and 24th hour</time_frame>
      <description>Morphine consumption will be assessed by checking patient controlled analgesia (PCA) device records and fentanyl consumption will be assessed by checking patient daily drug order records</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Numeric Rating Scale</measure>
      <time_frame>Postoperative 1st, 2nd, 4th, 8th 12th and 24th hour</time_frame>
      <description>A blinded nurse will assess postoperative pain during resting and movement at postoperative 1st, 2nd, 4th, 8th 12th and 24th hour by using 11-point Numerical Rating Scale which ranges from '0' (means no pain) to '10' (means worst pain imaginable)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse Reactions</measure>
      <time_frame>Postoperative 24th hour</time_frame>
      <description>Nausea, vomiting, constipation, urinary retention and skin rash/pruritus will be assessed</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Postoperative Recovery</condition>
    <condition>Abdominal Pain</condition>
    <condition>Cesarean Section</condition>
    <arm_group>
      <arm_group_label>Transversalis Fascia Plane Block (TFPB) Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>At TFPB group, the block will be performed by ultrasound guidance after completion of surgery. TFPB will be performed under ultrasonography guidance using a linear 6 to 13 megahertz ultrasound probe by the anesthesiologist. In TFPB group patients will receive 40 ml %0.25 bupivacaine divided into 2 equal doses between transversus abdominis muscle and transversalis fascia bilaterally.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Transversus Abdominis Plane (TAP) Block Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>At TAP block group, the block will be performed by ultrasound guidance after completion of surgery. TAP blocks will be performed under ultrasonography guidance using a linear 6 to 13 megahertz ultrasound probe by the anesthesiologist. In TAP block group patients will receive 40 ml %0.25 bupivacaine divided into 2 equal doses in the fascial plane between internal oblique muscle and transversus abdominis muscle bilaterally.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Transversalis Fascia Plane Block</intervention_name>
      <description>40 ml %0.25 bupivacaine divided into 2 equal doses will be injected by the anesthesiologist under ultrasonography guidance between transversus abdominis muscle and transversalis fascia bilaterally</description>
      <arm_group_label>Transversalis Fascia Plane Block (TFPB) Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Transversus Abdominis Plane Block</intervention_name>
      <description>40 ml %0.25 bupivacaine divided into 2 equal doses will be injected by the anesthesiologist under ultrasonography guidance in the fascial plane between internal oblique muscle and transversus abdominis muscle bilaterally</description>
      <arm_group_label>Transversus Abdominis Plane (TAP) Block Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  American Society of Anesthesiologists physical status II-III&#xD;
  &#xD;
            -  Cesarean section surgery under spinal anesthesia&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  American Society of Anesthesiologists physical status IV&#xD;
  &#xD;
            -  Emergency surgery&#xD;
  &#xD;
            -  General anesthesia&#xD;
  &#xD;
            -  Additional surgical intervention at the same session&#xD;
  &#xD;
            -  Body mass index of more than 35 kg/m2&#xD;
  &#xD;
            -  Allergy to any study drugs&#xD;
  &#xD;
            -  Local infection at the injection site&#xD;
  &#xD;
            -  History of drug abuse&#xD;
  &#xD;
            -  Communication problem&#xD;
  &#xD;
            -  Coagulopathy&#xD;
  &#xD;
            -  Preeclampsia and eclampsia&#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>Melike Korkmaz Toker, Associate Professor</last_name>
      <role>Principal Investigator</role>
      <affiliation>Mugla Sıtkı Kocman University Department of Anesthesiology and Reanimation</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Melike Korkmaz Toker, Associate Professor</last_name>
      <phone>00905054747098</phone>
      <email>meltoker@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Mugla Sıtkı Kocman University Training and Research Hospital</name>
        <address>
          <city>Mugla</city>
          <country>Turkey</country>
        </address>
      </facility>
      <contact>
        <last_name>Melike Korkmaz Toker, MD</last_name>
        <phone>00905054747098</phone>
        <email>meltoker@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Jadon A, Jain P, Chakraborty S, Motaka M, Parida SS, Sinha N, Agrawal A, Pati AK. Role of ultrasound guided transversus abdominis plane block as a component of multimodal analgesic regimen for lower segment caesarean section: a randomized double blind clinical study. BMC Anesthesiol. 2018 May 14;18(1):53. doi: 10.1186/s12871-018-0512-x.</citation>
      <PMID>29759061</PMID>
    </reference>
    <reference>
      <citation>Aydin ME, Bedir Z, Yayik AM, Celik EC, Ates I, Ahiskalioglu EO, Ahiskalioglu A. Subarachnoid block and ultrasound-guided transversalis fascia plane block for caesarean section: A randomised, double-blind, placebo-controlled trial. Eur J Anaesthesiol. 2020 Sep;37(9):765-772. doi: 10.1097/EJA.0000000000001222.</citation>
      <PMID>32412986</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Muğla Sıtkı Koçman University</investigator_affiliation>
      <investigator_full_name>Melike Korkmaz Toker</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <keyword>cesarean section surgery</keyword>
    <keyword>postoperative recovery</keyword>
    <keyword>postoperative pain</keyword>
    <keyword>trasversalis fascia plane block</keyword>
    <keyword>transversus abdominis plane block</keyword>
    <keyword>obstetric quality of recovery 11 Turkish score</keyword>
    <keyword>numeric rating scale</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Abdominal Pain</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>via mail</ipd_description>
    </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/NCT05999981
  org study id: MSKU 13-IV
  nct id: NCT05999981
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Inadequate pain control after cesarean section surgery causes postpartum depression,
        persistent pain and delayed mother-infant bonding. The investigator's aim is to asses whether
        ultrasound guided transversalis fascia plane block (TFPB) or transversus abdominis plane
        (TAP) block would improve postoperative quality of recovery and decrease postoperative opioid
        consumption after cesarean section surgery.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Care Provider, Outcomes Assessor)
  measure: Postoperative quality of recovery
  time frame: Postoperative 24th hour
  description: Postoperative quality of recovery will be assessed by Obstetric Quality of Recovery 11 Turkish (ObsQoR-11T) score
  measure: Postoperative opioid consumption
  time frame: Postoperative 1st, 2nd, 4th, 8th 12th and 24th hour
  description: Morphine consumption will be assessed by checking patient controlled analgesia (PCA) device records and fentanyl consumption will be assessed by checking patient daily drug order records
  measure: Numeric Rating Scale
  time frame: Postoperative 1st, 2nd, 4th, 8th 12th and 24th hour
  description: A blinded nurse will assess postoperative pain during resting and movement at postoperative 1st, 2nd, 4th, 8th 12th and 24th hour by using 11-point Numerical Rating Scale which ranges from '0' (means no pain) to '10' (means worst pain imaginable)
  measure: Adverse Reactions
  time frame: Postoperative 24th hour
  description: Nausea, vomiting, constipation, urinary retention and skin rash/pruritus will be assessed
  arm group label: Transversalis Fascia Plane Block (TFPB) Group
  arm group type: Active Comparator
  description: At TFPB group, the block will be performed by ultrasound guidance after completion of surgery. TFPB will be performed under ultrasonography guidance using a linear 6 to 13 megahertz ultrasound probe by the anesthesiologist. In TFPB group patients will receive 40 ml %0.25 bupivacaine divided into 2 equal doses between transversus abdominis muscle and transversalis fascia bilaterally.
  arm group label: Transversus Abdominis Plane (TAP) Block Group
  arm group type: Active Comparator
  description: At TAP block group, the block will be performed by ultrasound guidance after completion of surgery. TAP blocks will be performed under ultrasonography guidance using a linear 6 to 13 megahertz ultrasound probe by the anesthesiologist. In TAP block group patients will receive 40 ml %0.25 bupivacaine divided into 2 equal doses in the fascial plane between internal oblique muscle and transversus abdominis muscle bilaterally.
  intervention type: Procedure
  intervention name: Transversalis Fascia Plane Block
  description: 40 ml %0.25 bupivacaine divided into 2 equal doses will be injected by the anesthesiologist under ultrasonography guidance between transversus abdominis muscle and transversalis fascia bilaterally
  arm group label: Transversalis Fascia Plane Block (TFPB) Group
  intervention type: Procedure
  intervention name: Transversus Abdominis Plane Block
  description: 40 ml %0.25 bupivacaine divided into 2 equal doses will be injected by the anesthesiologist under ultrasonography guidance in the fascial plane between internal oblique muscle and transversus abdominis muscle bilaterally
  arm group label: Transversus Abdominis Plane (TAP) Block Group
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 45 Years
  healthy volunteers: No
  last name: Melike Korkmaz Toker, Associate Professor
  role: Principal Investigator
  affiliation: Mugla Sıtkı Kocman University Department of Anesthesiology and Reanimation
  last name: Melike Korkmaz Toker, Associate Professor
  phone: 00905054747098
  email: meltoker@gmail.com
  facility: 
  contact: 
  country: Turkey
  citation: Jadon A, Jain P, Chakraborty S, Motaka M, Parida SS, Sinha N, Agrawal A, Pati AK. Role of ultrasound guided transversus abdominis plane block as a component of multimodal analgesic regimen for lower segment caesarean section: a randomized double blind clinical study. BMC Anesthesiol. 2018 May 14;18(1):53. doi: 10.1186/s12871-018-0512-x.
  PMID: 29759061
  citation: Aydin ME, Bedir Z, Yayik AM, Celik EC, Ates I, Ahiskalioglu EO, Ahiskalioglu A. Subarachnoid block and ultrasound-guided transversalis fascia plane block for caesarean section: A randomised, double-blind, placebo-controlled trial. Eur J Anaesthesiol. 2020 Sep;37(9):765-772. doi: 10.1097/EJA.0000000000001222.
  PMID: 32412986
  responsible party type: Principal Investigator
  investigator affiliation: Muğla Sıtkı Koçman University
  investigator full name: Melike Korkmaz Toker
  investigator title: Associate Professor
  mesh term: Abdominal Pain
  sharing ipd: No
  ipd description: via mail