<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/NCT03244540</url>
  </required_header>
  <id_info>
    <org_study_id>KE-0254/127/2017</org_study_id>
    <nct_id>NCT03244540</nct_id>
  </id_info>
  <brief_title>Regional Analgesia After Cesarean Section</brief_title>
  <official_title>Efficacy of Regional Analgesia Techniques (Quadratus Lumborum Block and Transversus Abdominis Plane Block) in Acute and Chronic Pain Treatment in Patients After Cesarean Delivery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Lublin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Lublin</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>
      All patients will be anaesthetized with spinal technique. Each patient will be treated with&#xD;
      intravenous morphine - patient controlled analgesia (PCA). 2 of 3 groups of patients will&#xD;
      receive ultrasound-guided transversus abdominis plane or quadratus lumborum block to treat&#xD;
      postoperative pain. Postoperative pain will measured with visual-analogue scale (VAS). Total&#xD;
      morphine consumption and time to the first demand will be noted. 1, 2, 6 months after surgery&#xD;
      each patient will be called to assess neuropathic pain with Neuropathic Pain Symptom&#xD;
      Inventory (NPSI).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Written consent will be obtained before the cesarean section. Only subarachnoidally&#xD;
      anaesthetised patients may participate in the study. Pencil-point spinal needle and&#xD;
      bupivacaine (Marcaine Heavy Spinal 0.5 %) will be used.&#xD;
&#xD;
      All patients will receive PCA (patient controlled analgesia) pump with morphine (1 mg/mL, 5&#xD;
      minute interval, no loading dose) after transfer to PACU (post-anesthesia care unit). In PACU&#xD;
      vital signs will be monitored.&#xD;
&#xD;
      Each patient will be randomly assigned to one of three groups. In the first group of patients&#xD;
      no additional regional analgesia will be performed. In the second and the third group,&#xD;
      ultrasound-guided transversus abdominis plane or quadratus lumborum block will be done with&#xD;
      0.375 % ropivacaine (0.2 ml per kg on each side).&#xD;
&#xD;
      Postoperative pain will be measured with VAS (visual-analogue scale) 2, 4, 8, 12 and 24 hours&#xD;
      after the end of operation.&#xD;
&#xD;
      Paracetamol, metamizol, ketoprofen may be given as required.&#xD;
&#xD;
      1, 3, 6 months patients will be called to assess neuropathic pain. Neuropathic Pain Symptom&#xD;
      Inventory (NPSI) will be used.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 4, 2017</start_date>
  <completion_date type="Actual">August 30, 2019</completion_date>
  <primary_completion_date type="Actual">October 29, 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>
    <intervention_model_description>Participants were randomized 1:1:1</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
    <masking_description>Participants, care providers, and assessors were not aware of type of the block</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative pain measured with VAS</measure>
    <time_frame>up to 24 hours after surgery</time_frame>
    <description>Acute pain measured with VAS (visual-analogue scale)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Neuropathic pain assessed with NPSI</measure>
    <time_frame>6 months from the surgery</time_frame>
    <description>Neuropathic pain occurrence with Neuropathic Pain Symptom Inventory (NPSI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Morphine consumption</measure>
    <time_frame>up to 24 hours after surgery</time_frame>
    <description>Total morphine consumption</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">105</enrollment>
  <condition>Cesarean Section</condition>
  <condition>Pain, Postoperative</condition>
  <condition>Pain, Neuropathic</condition>
  <arm_group>
    <arm_group_label>PCA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subarchnoid anesthesia with bupivacaine PCA with morphine in the PACU</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TAP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subarchnoid anesthesia with bupivacaine TAP (transversus abdominis plane block) ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain. Stimuplex Ultra 360 needle will be used and 0.375 % ropivacaine administered (0.2 mL/kg) at the and of cesarean section.&#xD;
PCA with morphine in the PACU</description>
  </arm_group>
  <arm_group>
    <arm_group_label>QLB</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subarchnoid anesthesia with bupivacaine QLB (quadratus lumborum block) ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain. Stimuplex Ultra 360 needle will be used and 0.375 % ropivacaine administered (0.2 mL/kg) at the and of cesarean section.&#xD;
PCA with morphine in the PACU</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>TAP (transversus abdominis plane block)</intervention_name>
    <description>ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain</description>
    <arm_group_label>TAP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>QLB (quadratus lumborum block)</intervention_name>
    <description>ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain</description>
    <arm_group_label>QLB</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Stimuplex Ultra 360 needle</intervention_name>
    <description>ultrasound-guided needle will be used for QLB and TAP and regional blocks</description>
    <arm_group_label>QLB</arm_group_label>
    <arm_group_label>TAP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ropivacaine</intervention_name>
    <description>0.375 % ropivacaine will be administered for both QLB and TAP (0.2 mL per kg on both sides)</description>
    <arm_group_label>QLB</arm_group_label>
    <arm_group_label>TAP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paracetamol</intervention_name>
    <description>Intravenous paracetamol will be used (1.0 gram), up to 4 grams per day</description>
    <arm_group_label>PCA</arm_group_label>
    <arm_group_label>QLB</arm_group_label>
    <arm_group_label>TAP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>subarachnoid anesthesia</intervention_name>
    <description>subarachnoid anesthesia for each patients participating in the study with pencil point needle</description>
    <arm_group_label>PCA</arm_group_label>
    <arm_group_label>QLB</arm_group_label>
    <arm_group_label>TAP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>PCA (patient controlled analgesia)</intervention_name>
    <description>All patients will receive PCA pump with morphine (1 mg/mL, 5 minute interval, no loading dose) after transfer to PACU (post-anesthesia care unit)</description>
    <arm_group_label>PCA</arm_group_label>
    <arm_group_label>QLB</arm_group_label>
    <arm_group_label>TAP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metamizol</intervention_name>
    <description>Intravenous metamizol will be used (1.0 gram), up to 4 grams per day</description>
    <arm_group_label>PCA</arm_group_label>
    <arm_group_label>QLB</arm_group_label>
    <arm_group_label>TAP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ketoprofen</intervention_name>
    <description>Intravenous ketoprofen will be used (0.1 gram), up to 200 milligrams per day</description>
    <arm_group_label>PCA</arm_group_label>
    <arm_group_label>QLB</arm_group_label>
    <arm_group_label>TAP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine</intervention_name>
    <description>Subarachnoid anesthesia with spinal bupivacaine (MARCAINE SPINAL 0.5% HEAVY)</description>
    <arm_group_label>PCA</arm_group_label>
    <arm_group_label>QLB</arm_group_label>
    <arm_group_label>TAP</arm_group_label>
    <other_name>Marcaine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  obtained consent&#xD;
&#xD;
          -  singleton pregnancy&#xD;
&#xD;
          -  subarachnoid anaesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  coagulopathy&#xD;
&#xD;
          -  allergy to morphine and local anesthetics&#xD;
&#xD;
          -  depression, antidepressant drugs treatment&#xD;
&#xD;
          -  epilepsy&#xD;
&#xD;
          -  usage of painkiller before surgery&#xD;
&#xD;
          -  addiction to alcohol or recreational drugs&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Szpital Specjalistyczny PRO-FAMILIA w Rzeszowie</name>
      <address>
        <city>Rzeszów</city>
        <zip>35-001</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpital Kliniczny Dzieciątka Jezus</name>
      <address>
        <city>Warszawa</city>
        <zip>02-005</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <reference>
    <citation>Kadam VR. Ultrasound-guided quadratus lumborum block as a postoperative analgesic technique for laparotomy. J Anaesthesiol Clin Pharmacol. 2013 Oct;29(4):550-2. doi: 10.4103/0970-9185.119148.</citation>
    <PMID>24249997</PMID>
  </reference>
  <reference>
    <citation>Kadam VR. Ultrasound guided quadratus lumborum block or posterior transversus abdominis plane block catheter infusion as a postoperative analgesic technique for abdominal surgery. J Anaesthesiol Clin Pharmacol. 2015 Jan-Mar;31(1):130-1. doi: 10.4103/0970-9185.150575. No abstract available.</citation>
    <PMID>25788791</PMID>
  </reference>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>August 4, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>February 16, 2020</last_update_submitted>
  <last_update_submitted_qc>February 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Lublin</investigator_affiliation>
    <investigator_full_name>Michał Borys</investigator_full_name>
    <investigator_title>associate professor</investigator_title>
  </responsible_party>
  <keyword>postoperative pain</keyword>
  <keyword>transversus abdominis plane block</keyword>
  <keyword>quadratus lumborum block</keyword>
  <keyword>neuropathic pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neuralgia</mesh_term>
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetaminophen</mesh_term>
    <mesh_term>Dipyrone</mesh_term>
    <mesh_term>Ketoprofen</mesh_term>
    <mesh_term>Bupivacaine</mesh_term>
    <mesh_term>Ropivacaine</mesh_term>
  </intervention_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/NCT03244540
org study id: KE-0254/127/2017
nct id: NCT03244540
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
All patients will be anaesthetized with spinal technique. Each patient will be treated with
      intravenous morphine - patient controlled analgesia (PCA). 2 of 3 groups of patients will
      receive ultrasound-guided transversus abdominis plane or quadratus lumborum block to treat
      postoperative pain. Postoperative pain will measured with visual-analogue scale (VAS). Total
      morphine consumption and time to the first demand will be noted. 1, 2, 6 months after surgery
      each patient will be called to assess neuropathic pain with Neuropathic Pain Symptom
      Inventory (NPSI).
Written consent will be obtained before the cesarean section. Only subarachnoidally
      anaesthetised patients may participate in the study. Pencil-point spinal needle and
      bupivacaine (Marcaine Heavy Spinal 0.5 %) will be used.

      All patients will receive PCA (patient controlled analgesia) pump with morphine (1 mg/mL, 5
      minute interval, no loading dose) after transfer to PACU (post-anesthesia care unit). In PACU
      vital signs will be monitored.

      Each patient will be randomly assigned to one of three groups. In the first group of patients
      no additional regional analgesia will be performed. In the second and the third group,
      ultrasound-guided transversus abdominis plane or quadratus lumborum block will be done with
      0.375 % ropivacaine (0.2 ml per kg on each side).

      Postoperative pain will be measured with VAS (visual-analogue scale) 2, 4, 8, 12 and 24 hours
      after the end of operation.

      Paracetamol, metamizol, ketoprofen may be given as required.

      1, 3, 6 months patients will be called to assess neuropathic pain. Neuropathic Pain Symptom
      Inventory (NPSI) will be used.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants were randomized 1:1:1
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
masking description: Participants, care providers, and assessors were not aware of type of the block
measure: Postoperative pain measured with VAS
time frame: up to 24 hours after surgery
description: Acute pain measured with VAS (visual-analogue scale)
measure: Neuropathic pain assessed with NPSI
time frame: 6 months from the surgery
description: Neuropathic pain occurrence with Neuropathic Pain Symptom Inventory (NPSI)
measure: Morphine consumption
time frame: up to 24 hours after surgery
description: Total morphine consumption
arm group label: PCA
arm group type: Experimental
description: Subarchnoid anesthesia with bupivacaine PCA with morphine in the PACU
arm group label: TAP
arm group type: Experimental
description: Subarchnoid anesthesia with bupivacaine TAP (transversus abdominis plane block) ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain. Stimuplex Ultra 360 needle will be used and 0.375 % ropivacaine administered (0.2 mL/kg) at the and of cesarean section.
PCA with morphine in the PACU
arm group label: QLB
arm group type: Experimental
description: Subarchnoid anesthesia with bupivacaine QLB (quadratus lumborum block) ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain. Stimuplex Ultra 360 needle will be used and 0.375 % ropivacaine administered (0.2 mL/kg) at the and of cesarean section.
PCA with morphine in the PACU
intervention type: Procedure
intervention name: TAP (transversus abdominis plane block)
description: ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain
arm group label: TAP
intervention type: Procedure
intervention name: QLB (quadratus lumborum block)
description: ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain
arm group label: QLB
intervention type: Device
intervention name: Stimuplex Ultra 360 needle
description: ultrasound-guided needle will be used for QLB and TAP and regional blocks
arm group label: QLB
arm group label: TAP
intervention type: Drug
intervention name: Ropivacaine
description: 0.375 % ropivacaine will be administered for both QLB and TAP (0.2 mL per kg on both sides)
arm group label: QLB
arm group label: TAP
intervention type: Drug
intervention name: Paracetamol
description: Intravenous paracetamol will be used (1.0 gram), up to 4 grams per day
arm group label: PCA
arm group label: QLB
arm group label: TAP
intervention type: Procedure
intervention name: subarachnoid anesthesia
description: subarachnoid anesthesia for each patients participating in the study with pencil point needle
arm group label: PCA
arm group label: QLB
arm group label: TAP
intervention type: Procedure
intervention name: PCA (patient controlled analgesia)
description: All patients will receive PCA pump with morphine (1 mg/mL, 5 minute interval, no loading dose) after transfer to PACU (post-anesthesia care unit)
arm group label: PCA
arm group label: QLB
arm group label: TAP
intervention type: Drug
intervention name: Metamizol
description: Intravenous metamizol will be used (1.0 gram), up to 4 grams per day
arm group label: PCA
arm group label: QLB
arm group label: TAP
intervention type: Drug
intervention name: Ketoprofen
description: Intravenous ketoprofen will be used (0.1 gram), up to 200 milligrams per day
arm group label: PCA
arm group label: QLB
arm group label: TAP
intervention type: Drug
intervention name: Bupivacaine
description: Subarachnoid anesthesia with spinal bupivacaine (MARCAINE SPINAL 0.5% HEAVY)
arm group label: PCA
arm group label: QLB
arm group label: TAP
other name: Marcaine
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
facility: 
country: Poland
citation: Kadam VR. Ultrasound-guided quadratus lumborum block as a postoperative analgesic technique for laparotomy. J Anaesthesiol Clin Pharmacol. 2013 Oct;29(4):550-2. doi: 10.4103/0970-9185.119148.
PMID: 24249997
citation: Kadam VR. Ultrasound guided quadratus lumborum block or posterior transversus abdominis plane block catheter infusion as a postoperative analgesic technique for abdominal surgery. J Anaesthesiol Clin Pharmacol. 2015 Jan-Mar;31(1):130-1. doi: 10.4103/0970-9185.150575. No abstract available.
PMID: 25788791
responsible party type: Principal Investigator
investigator affiliation: Medical University of Lublin
investigator full name: Michał Borys
investigator title: associate professor
mesh term: Neuralgia
mesh term: Pain, Postoperative
mesh term: Acetaminophen
mesh term: Dipyrone
mesh term: Ketoprofen
mesh term: Bupivacaine
mesh term: Ropivacaine
sharing ipd: No