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/NCT06010602</url>
    </required_header>
    <id_info>
      <org_study_id>GaziosmanpasaTREH47</org_study_id>
      <nct_id>NCT06010602</nct_id>
    </id_info>
    <brief_title>Postoperative Analgesia After Cesarean Section</brief_title>
    <official_title>COMPARISON OF THE POSTOPERATIVE ANALGESIC EFFECTIVENESS OF QUADRATUS LUMBORUM BLOCK (QLB) and ILIOINGUINAL -ILIOHIPOGASTRIC (II-IH) NERVE BLOCK IN CAESER SECTION OPERATIONS</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Gaziosmanpasa Research and Education Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Gaziosmanpasa Research and Education Hospital</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>
        We planned to compare the post-operative analgesic efficacy of Ilioinguinal iliohypogastric&#xD;
        (II-IH) nerve block and Quadratus lumborum III Block in elective cesarean section operations.&#xD;
  &#xD;
        Our primary aim is; To compare and evaluate the first rescue analgesia requirement times&#xD;
        after Quadratus lumborum III and II-IH Block for postoperative analgesia after elective&#xD;
        cesarean section operations under spinal anesthesia.&#xD;
  &#xD;
        Our secondary aims are:&#xD;
  &#xD;
          1. To compare the amount of total analgesic use in the first 24 hours in patients&#xD;
  &#xD;
          2. To compare the NRS (Numering rating scale) values (resting and dynamic) at 2. 4. 8. 12 .&#xD;
             24. hours in the postoperative follow-up of the patients&#xD;
  &#xD;
          3. Comparing the side effects such as postoperative nausea and vomiting&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Patients who underwent elective cesarean section under spinal anesthesia will be divided into&#xD;
        two groups at the end of the operation, using the closed envelope randomization method as&#xD;
        Quadratus lumborum III and II-IH nerve block. Spinal anesthesia will be applied to all&#xD;
        patients who will undergo elective cesarean section. At the end of the operation, they will&#xD;
        be taken to the postoperative block room. All blocks will be performed by the same&#xD;
        anesthesiologist under USG guidance. 20 ml of 0.25% bupivacaine will be used in the blocks.&#xD;
        All patients will be followed in the block room for 30 minutes after the block application.&#xD;
        Patients with a Modified Aldret score above 8 will be sent to the service because they are&#xD;
        under spinal anesthesia at the end of the operation.At the end of the operation, when the&#xD;
        spinal level regresses to two dermatome levels, paracetamol 1gr IV will be administered to&#xD;
        all patients for post-op analgesia.Postoperative analgesia was planned for the patients as&#xD;
        paracetamol 4x1 gr. Tramadol hydrochloride 1mg/kg was planned as rescue analgesia in the ward&#xD;
        for patients with NRS scores greater than 3 in their postoperative follow-up.&#xD;
  &#xD;
        Patients 2.,4.,8.,12.,24. hours will be followed by an anesthesia assistant who is different&#xD;
        from the researcher who applied the block and who is blind for the study. The patients' first&#xD;
        rescue analgesia times, NRS scores, postoperative side effects, and total analgesic amounts&#xD;
        used in 24 hours will be recorded.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">May 1, 2023</start_date>
    <completion_date type="Anticipated">December 15, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 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>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Comparison of first rescue analgesia</measure>
      <time_frame>24 hour</time_frame>
      <description>For all patients, postoperative analgesia was planned as paracetamol 1g four times a day for the first 24 hours after surgery. Patients with Numeric Rating Scale (NRS) scores greater than 3 at 2, 4, 8, 12, and 24 hours postoperatively will receive rescue analgesia with tramadol hydrochloride at a dose of 1mg/kg. The time of the first administration of tramadol hydrochloride for each patient will be compared.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>comparing the amount of total analgesic use in the first 24 hours in patients</measure>
      <time_frame>24 hours</time_frame>
      <description>For all patients, postoperative analgesia was planned as paracetamol 1g four times a day for the first 24 hours after surgery. Patients with Numeric Rating Scale (NRS) scores greater than 3 at 2, 4, 8, 12, and 24 hours postoperatively will receive rescue analgesia with tramadol hydrochloride at a dose of 1mg/kg.The total tramadol consumption of patients within the first 24 hours will be compared.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Comparing the NRS values in 2,4,8,12,24 hours in the postoperative follow-up of the patients</measure>
      <time_frame>24 hours</time_frame>
      <description>To compare the Numeric Rating Scale (NRS) values (at rest and with movement) of the patients during postoperative follow-ups at 2, 4, 8, 12, and 24 hours.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Comparing side effects such as postoperative nausea and vomiting</measure>
      <time_frame>24 hours</time_frame>
      <description>To compare postoperative side effects such as nausea and vomiting within the first 24 hours.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Postoperative Pain</condition>
    <arm_group>
      <arm_group_label>Quadratus lumborum block group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>the patient In the lateral decubitus position, a subcostal area and above the iliac crest in the mid-axillary line, a convex ultrasound probe is placed under sterile conditions. Using an in-plane technique, the quadratus lumborum and psoas major muscles, as well as the transverse process of the L4 vertebra, are visualized. 22G, 100 mm peripheral block needle is used to perform the block. The needle is directed between the quadratus lumborum muscle and the psoas major muscle in the subfascial plane, following hydrodissection for proper needle placement. Then, 20 mL of 0.25% bupivacaine is injected slowly, aspirating every 5 cc to ensure proper spread. The injection is performed under ultrasound guidance, visualizing the local anesthetic pushing the fascia. The same procedure will be repeated for the other side.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>İlioinguinal-İliohipogastric nerve block group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>the patient in the supine position, a linear ultrasound probe is placed over the spina iliaca anterior superior (SIAS) line, drawn from SIAS to the umbilicus. The probe is used to visualize the abdominal wall muscles, focusing on the fascial plane between the transversus abdominis and internal oblique muscles, where a flattened football-like appearance is seen. The iliohypogastric nerve is observed more laterally, and the ilioinguinal nerve is seen more medially. Using an in-plane technique with 22G, 100 mm peripheral block needle, local anesthetic is injected near the SIAS, between the transversus abdominis and internal oblique muscles. Again, 20 mL of 0.25% bupivacaine is injected slowly, aspirating every 5 cc, and the injection is visualized under ultrasound guidance, ensuring proper fascial spread. The same procedure will be repeated for the other side.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Quadratus lumborum block</intervention_name>
      <description>For all patients, postoperative analgesia was planned as paracetamol 1g four times a day for the first 24 hours after surgery. Patients with Numeric Rating Scale (NRS) scores greater than 3 at 2, 4, 8, 12, and 24 hours postoperatively were administered rescue analgesia with tramadol hydrochloride at a dose of 1mg/kg.</description>
      <arm_group_label>Quadratus lumborum block group</arm_group_label>
      <other_name>Intravenous analgesic medication</other_name>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>İlioinguinal-İliohipogastric nerve block</intervention_name>
      <description>For all patients, postoperative analgesia was planned as paracetamol 1g four times a day for the first 24 hours after surgery. Patients with Numeric Rating Scale (NRS) scores greater than 3 at 2, 4, 8, 12, and 24 hours postoperatively were administered rescue analgesia with tramadol hydrochloride at a dose of 1mg/kg.</description>
      <arm_group_label>İlioinguinal-İliohipogastric nerve block group</arm_group_label>
      <other_name>Intravenous analgesic medication</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria: ASA 1-2, Patients at 37-41 weeks of pregnancy&#xD;
  &#xD;
          -&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          The patient does not accept the procedure. Patients with a history of eclampsia and&#xD;
          preeclampsia during pregnancy local anesthetic allergy Infection at the procedure site&#xD;
          Anticoagulant use with bleeding disorder Chronic analgesia and opioid use Mental,&#xD;
          psychiatric and neurological problems Patients with ASA 3 and above with a history of any&#xD;
          chronic disease.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>serpil sehirlioglu</last_name>
      <role>Principal Investigator</role>
      <affiliation>Gaziosmanpasa Research and Education Hospital</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Gaziosmanpasa Research and Education Hospital</name>
        <address>
          <city>Istanbul</city>
          <zip>34000</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <results_reference>
      <citation>Irwin R, Stanescu S, Buzaianu C, Rademan M, Roddy J, Gormley C, Tan T. Quadratus lumborum block for analgesia after caesarean section: a randomised controlled trial. Anaesthesia. 2020 Jan;75(1):89-95. doi: 10.1111/anae.14852. Epub 2019 Sep 15.</citation>
      <PMID>31523801</PMID>
    </results_reference>
    <results_reference>
      <citation>Yetik F, Yilmaz C, Karasu D, Haliloglu Dastan N, Dayioglu M, Baytar C. Comparison of ultrasound-guided quadratus lumborum block-2 and quadratus lumborum block-3 for postoperative pain in cesarean section: A randomized clinical trial. Medicine (Baltimore). 2022 Dec 9;101(49):e31844. doi: 10.1097/MD.0000000000031844.</citation>
      <PMID>36626453</PMID>
    </results_reference>
    <results_reference>
      <citation>Koksal E, Aygun H, Genc C, Kaya C, Dost B. Comparison of the analgesic effects of two quadratus lumborum blocks (QLBs), QLB type II vs QLB type III, in caesarean delivery: A randomised study. Int J Clin Pract. 2021 Oct;75(10):e14513. doi: 10.1111/ijcp.14513. Epub 2021 Jun 23.</citation>
      <PMID>34117829</PMID>
    </results_reference>
    <results_reference>
      <citation>Staker JJ, Liu D, Church R, Carlson DJ, Panahkhahi M, Lim A, LeCong T. A triple-blind, placebo-controlled randomised trial of the ilioinguinal-transversus abdominis plane (I-TAP) nerve block for elective caesarean section. Anaesthesia. 2018 May;73(5):594-602. doi: 10.1111/anae.14222. Epub 2018 Jan 29.</citation>
      <PMID>29377066</PMID>
    </results_reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>August 20, 2023</study_first_submitted>
    <study_first_submitted_qc>August 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 20, 2023</last_update_submitted>
    <last_update_submitted_qc>August 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>cesarean section</keyword>
    <keyword>Quadratus lumborum III block</keyword>
    <keyword>Ilioinguinal iliohypogastric block</keyword>
    <keyword>analgesia</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pain, Postoperative</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Analgesics</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/NCT06010602
  org study id: GaziosmanpasaTREH47
  nct id: NCT06010602
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  We planned to compare the post-operative analgesic efficacy of Ilioinguinal iliohypogastric
        (II-IH) nerve block and Quadratus lumborum III Block in elective cesarean section operations.
  
        Our primary aim is; To compare and evaluate the first rescue analgesia requirement times
        after Quadratus lumborum III and II-IH Block for postoperative analgesia after elective
        cesarean section operations under spinal anesthesia.
  
        Our secondary aims are:
  
          1. To compare the amount of total analgesic use in the first 24 hours in patients
  
          2. To compare the NRS (Numering rating scale) values (resting and dynamic) at 2. 4. 8. 12 .
             24. hours in the postoperative follow-up of the patients
  
          3. Comparing the side effects such as postoperative nausea and vomiting
  Patients who underwent elective cesarean section under spinal anesthesia will be divided into
        two groups at the end of the operation, using the closed envelope randomization method as
        Quadratus lumborum III and II-IH nerve block. Spinal anesthesia will be applied to all
        patients who will undergo elective cesarean section. At the end of the operation, they will
        be taken to the postoperative block room. All blocks will be performed by the same
        anesthesiologist under USG guidance. 20 ml of 0.25% bupivacaine will be used in the blocks.
        All patients will be followed in the block room for 30 minutes after the block application.
        Patients with a Modified Aldret score above 8 will be sent to the service because they are
        under spinal anesthesia at the end of the operation.At the end of the operation, when the
        spinal level regresses to two dermatome levels, paracetamol 1gr IV will be administered to
        all patients for post-op analgesia.Postoperative analgesia was planned for the patients as
        paracetamol 4x1 gr. Tramadol hydrochloride 1mg/kg was planned as rescue analgesia in the ward
        for patients with NRS scores greater than 3 in their postoperative follow-up.
  
        Patients 2.,4.,8.,12.,24. hours will be followed by an anesthesia assistant who is different
        from the researcher who applied the block and who is blind for the study. The patients' first
        rescue analgesia times, NRS scores, postoperative side effects, and total analgesic amounts
        used in 24 hours will be recorded.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Comparison of first rescue analgesia
  time frame: 24 hour
  description: For all patients, postoperative analgesia was planned as paracetamol 1g four times a day for the first 24 hours after surgery. Patients with Numeric Rating Scale (NRS) scores greater than 3 at 2, 4, 8, 12, and 24 hours postoperatively will receive rescue analgesia with tramadol hydrochloride at a dose of 1mg/kg. The time of the first administration of tramadol hydrochloride for each patient will be compared.
  measure: comparing the amount of total analgesic use in the first 24 hours in patients
  time frame: 24 hours
  description: For all patients, postoperative analgesia was planned as paracetamol 1g four times a day for the first 24 hours after surgery. Patients with Numeric Rating Scale (NRS) scores greater than 3 at 2, 4, 8, 12, and 24 hours postoperatively will receive rescue analgesia with tramadol hydrochloride at a dose of 1mg/kg.The total tramadol consumption of patients within the first 24 hours will be compared.
  measure: Comparing the NRS values in 2,4,8,12,24 hours in the postoperative follow-up of the patients
  time frame: 24 hours
  description: To compare the Numeric Rating Scale (NRS) values (at rest and with movement) of the patients during postoperative follow-ups at 2, 4, 8, 12, and 24 hours.
  measure: Comparing side effects such as postoperative nausea and vomiting
  time frame: 24 hours
  description: To compare postoperative side effects such as nausea and vomiting within the first 24 hours.
  arm group label: Quadratus lumborum block group
  arm group type: Active Comparator
  description: the patient In the lateral decubitus position, a subcostal area and above the iliac crest in the mid-axillary line, a convex ultrasound probe is placed under sterile conditions. Using an in-plane technique, the quadratus lumborum and psoas major muscles, as well as the transverse process of the L4 vertebra, are visualized. 22G, 100 mm peripheral block needle is used to perform the block. The needle is directed between the quadratus lumborum muscle and the psoas major muscle in the subfascial plane, following hydrodissection for proper needle placement. Then, 20 mL of 0.25% bupivacaine is injected slowly, aspirating every 5 cc to ensure proper spread. The injection is performed under ultrasound guidance, visualizing the local anesthetic pushing the fascia. The same procedure will be repeated for the other side.
  arm group label: İlioinguinal-İliohipogastric nerve block group
  arm group type: Active Comparator
  description: the patient in the supine position, a linear ultrasound probe is placed over the spina iliaca anterior superior (SIAS) line, drawn from SIAS to the umbilicus. The probe is used to visualize the abdominal wall muscles, focusing on the fascial plane between the transversus abdominis and internal oblique muscles, where a flattened football-like appearance is seen. The iliohypogastric nerve is observed more laterally, and the ilioinguinal nerve is seen more medially. Using an in-plane technique with 22G, 100 mm peripheral block needle, local anesthetic is injected near the SIAS, between the transversus abdominis and internal oblique muscles. Again, 20 mL of 0.25% bupivacaine is injected slowly, aspirating every 5 cc, and the injection is visualized under ultrasound guidance, ensuring proper fascial spread. The same procedure will be repeated for the other side.
  intervention type: Procedure
  intervention name: Quadratus lumborum block
  description: For all patients, postoperative analgesia was planned as paracetamol 1g four times a day for the first 24 hours after surgery. Patients with Numeric Rating Scale (NRS) scores greater than 3 at 2, 4, 8, 12, and 24 hours postoperatively were administered rescue analgesia with tramadol hydrochloride at a dose of 1mg/kg.
  arm group label: Quadratus lumborum block group
  other name: Intravenous analgesic medication
  intervention type: Procedure
  intervention name: İlioinguinal-İliohipogastric nerve block
  description: For all patients, postoperative analgesia was planned as paracetamol 1g four times a day for the first 24 hours after surgery. Patients with Numeric Rating Scale (NRS) scores greater than 3 at 2, 4, 8, 12, and 24 hours postoperatively were administered rescue analgesia with tramadol hydrochloride at a dose of 1mg/kg.
  arm group label: İlioinguinal-İliohipogastric nerve block group
  other name: Intravenous analgesic medication
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 40 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: serpil sehirlioglu
  role: Principal Investigator
  affiliation: Gaziosmanpasa Research and Education Hospital
  facility: 
  country: Turkey
  citation: Irwin R, Stanescu S, Buzaianu C, Rademan M, Roddy J, Gormley C, Tan T. Quadratus lumborum block for analgesia after caesarean section: a randomised controlled trial. Anaesthesia. 2020 Jan;75(1):89-95. doi: 10.1111/anae.14852. Epub 2019 Sep 15.
  PMID: 31523801
  citation: Yetik F, Yilmaz C, Karasu D, Haliloglu Dastan N, Dayioglu M, Baytar C. Comparison of ultrasound-guided quadratus lumborum block-2 and quadratus lumborum block-3 for postoperative pain in cesarean section: A randomized clinical trial. Medicine (Baltimore). 2022 Dec 9;101(49):e31844. doi: 10.1097/MD.0000000000031844.
  PMID: 36626453
  citation: Koksal E, Aygun H, Genc C, Kaya C, Dost B. Comparison of the analgesic effects of two quadratus lumborum blocks (QLBs), QLB type II vs QLB type III, in caesarean delivery: A randomised study. Int J Clin Pract. 2021 Oct;75(10):e14513. doi: 10.1111/ijcp.14513. Epub 2021 Jun 23.
  PMID: 34117829
  citation: Staker JJ, Liu D, Church R, Carlson DJ, Panahkhahi M, Lim A, LeCong T. A triple-blind, placebo-controlled randomised trial of the ilioinguinal-transversus abdominis plane (I-TAP) nerve block for elective caesarean section. Anaesthesia. 2018 May;73(5):594-602. doi: 10.1111/anae.14222. Epub 2018 Jan 29.
  PMID: 29377066
  responsible party type: Sponsor
  mesh term: Pain, Postoperative
  mesh term: Analgesics
  sharing ipd: No