<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/NCT04402411</url>
  </required_header>
  <id_info>
    <org_study_id>201617049.3</org_study_id>
    <nct_id>NCT04402411</nct_id>
  </id_info>
  <brief_title>Quadratus Lumborum Block vs Transversus Abdominis Plane Block in Bladder Cancer Surgeries</brief_title>
  <official_title>Comparison Between Quadratus Lumborum Block and Transversus Abdominis Plane Block in Bladder Cancer Surgeries</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cancer Institute, Egypt</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Cancer Institute, Egypt</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Transversus abdominis plane (TAP) block can be used to provide effective analgesia during the&#xD;
      postoperative period following a range of surgeries.&#xD;
&#xD;
      TAP block administers local anesthetics between the T6 to L1 spinal nerve roots to stop the&#xD;
      nerve signal and to alleviate pain for abdominal procedures 4, 5.&#xD;
&#xD;
      The viscera are innervated by the vagal nerve (parasympathetic innervation) and by the&#xD;
      splanchnic nerves (sympathetic innervation). The splanchnic nerves carry both visceral&#xD;
      efferent and afferent nerve fibers. The sensory (or afferent) part of the splanchnic nerves&#xD;
      reach the spinal column at certain spinal segments, It is possible to block central visceral&#xD;
      pain conduction with thoracic paravertebral blockade or maybe even with the novel quadratus&#xD;
      lumborum (QL) block.&#xD;
&#xD;
      The effect of the QL block is believed to result from a spread of LA from its lumbar&#xD;
      deposition cranially into the thoracic paravertebral space (TPVS), since Carney et al found&#xD;
      traces of contrast agent in the TPVS following application of this block. Hence, the QL block&#xD;
      would seem to be able to alleviate both somatic and visceral pain.10&#xD;
&#xD;
      The aim of this study is to compare between quadratus lumborum block, transversus abdominis&#xD;
      plane block regarding perioperative analgesia after bladder cancer surgeries by measuring&#xD;
      intraoperative hemodynamics, postoperative pain scores and morphine consumption in the first&#xD;
      24 h postoperative.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Somatic post-surgical pain is very distressing to patients which leads to important&#xD;
      complications. Combined multimodal strategies involving nerve blocks, neuroaxial blocks,&#xD;
      opiates, and non-steroidal anti-inflammatory drugs are necessary for optimal pain control.&#xD;
&#xD;
      Transversus abdominis plane (TAP) block can be used to provide effective analgesia during the&#xD;
      postoperative period following a range of surgeries.&#xD;
&#xD;
      TAP block administers local anesthetics between the T6 to L1 spinal nerve roots to stop the&#xD;
      nerve signal and to alleviate pain for abdominal procedures.&#xD;
&#xD;
      A number of systematic reviews have assessed TAP block as a postoperative analgesic compared&#xD;
      to one or more specific procedures.&#xD;
&#xD;
      Anterior abdominal wall blocks, as transverse abdominal plexus block, have an important role&#xD;
      for only somatic intraoperative and postoperative pain control.&#xD;
&#xD;
      The viscera are innervated by the vagal nerve (parasympathetic innervation) and by the&#xD;
      splanchnic nerves (sympathetic innervation). The splanchnic nerves carry both visceral&#xD;
      efferent and afferent nerve fibers. The sensory (or afferent) part of the splanchnic nerves&#xD;
      reach the spinal column at certain spinal segments, It is possible to block central visceral&#xD;
      pain conduction with thoracic paravertebral blockade or maybe even with the novel quadratus&#xD;
      lumborum (QL) block.&#xD;
&#xD;
      The effect of the QL block is believed to result from a spread of LA from its lumbar&#xD;
      deposition cranially into the thoracic paravertebral space (TPVS), since Carney et al found&#xD;
      traces of contrast agent in the TPVS following application of this block. Hence, the QL block&#xD;
      would seem to be able to alleviate both somatic and visceral pain.10 Quadratus lumborum block&#xD;
      was first described by Blanco in 2007. Blanco described a potential space posterior to the&#xD;
      abdominal wall muscles and lateral to the quadratus lumborum muscle. It has been used in&#xD;
      abdominoplasties, caesarean sections and lower abdominal operations providing complete pain&#xD;
      relief in the distribution area from Th6 to L1 dermatomes. It may be seen as a lumbar&#xD;
      approach to the Thoracic Paravertebral Space. The block apparently produces distribution of&#xD;
      the local anesthetic extending proximally and over both sides of the surface of the QL&#xD;
      muscle, in between the anterior and intermediate layers of the thoracolumbar fascia.&#xD;
&#xD;
      Quadratus lumborum muscle inserts on the lower border of the last rib and by four small&#xD;
      tendons into the apices of the transverse processes of the upper four lumbar vertebrae.&#xD;
&#xD;
      Running between its fascia and the muscle are the twelfth thoracic (subcostal), ilioinguinal,&#xD;
      and iliohypogastric nerves, The block does not rely on the feeling of any pops or fascial&#xD;
      clicks because depending of the angle of the needle several pops can be felt without reaching&#xD;
      the target zone, which is lateral to the quadratus lumborum muscle. Actually, the block has&#xD;
      never been intended to be conducted without the use of US guidance, and the block is thus a&#xD;
      purely USG block.&#xD;
&#xD;
      Aim of study Comparison between quadratus lumborum block, transversus abdominis plane block&#xD;
      regarding perioperative analgesia after bladder cancer surgeries by measuring intraoperative&#xD;
      hemodynamics, postoperative pain scores and morphine consumption in the first 24 h&#xD;
      postoperative.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Anticipated">October 5, 2020</completion_date>
  <primary_completion_date type="Actual">September 30, 2020</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to first rescue dose of morphine</measure>
    <time_frame>24 hours</time_frame>
    <description>First time at which morphine was given postoperatively (If Vsual analogue scale (VAS) was &gt;4, 3 mg morphine IV was administered as a rescue analgesia for the first 24 hours)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total dose of postoperative morphine consumption</measure>
    <time_frame>24 hours</time_frame>
    <description>Postoperative analgesia was provided by 1 gm paracetamol IV every 8 hours as a routine analgesia and if VAS was &gt;4, 3 mg morphine IV was administered as a rescue analgesia for the first 24 hours.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain intensity by visual analogue scale (VAS)</measure>
    <time_frame>24 hours</time_frame>
    <description>Visual analogue scale (VAS) was recorded at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24 hours postoperative.&#xD;
(0: No pain, 1-3: Mild pain, 4-6: Moderate pain, 7-9: Severe pain and 10: The worst imaginable pain) Minimum:0 and Maximum 10 The higher, the worst</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">63</enrollment>
  <condition>Quadratus Lumborum Block</condition>
  <condition>Transversus Abdominis Plane Block</condition>
  <condition>Bladder Cancer</condition>
  <condition>Postoperative Pain</condition>
  <condition>Surgery</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive general anesthesia with intravenous opioid</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Quadratus lumborum</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive bilateral quadratus lumborum block</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Transversus abdominis plane</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive bilateral transversus abdominis plane block</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Quadratus lumborum block</intervention_name>
    <description>The patient will be placed in a lateral position with the side to be blocked facing upwards. The ultrasound probe will be properly sterilized and with sterile covers. An 18-20 gauge blunt tipped block needle or a Tuohy needle is advanced under ultrasound guidance on the posterior aspect of the Quadratus Lumborum. The QL muscle is identified with its attachment to the lateral edge of the transverse process of the L4 vertebral body. With the psoas major muscle anteriorly, the erector spinae muscle posteriorly and the QL muscle adherent to the apex of the transverse process, a well recognisable pattern of a shamrock with three leaves can be seen.</description>
    <arm_group_label>Quadratus lumborum</arm_group_label>
    <other_name>Group B</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Transversus abdominis plane block</intervention_name>
    <description>The patient will be supine while performing the block and sterilization of the site of the ultrasound and needle entry will be performed.&#xD;
The ultrasound probe is placed in a transverse plane to the lateral abdominal wall in the midaxillary line, between the lower costal margin and iliac crest.&#xD;
The needle is introduced in plane of the ultrasound probe directly under the probe and advanced until it reaches the plane between the internal oblique and transversus abdominis muscles.</description>
    <arm_group_label>Transversus abdominis plane</arm_group_label>
    <other_name>Group C</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intravenous opioid</intervention_name>
    <description>Patients will receive morphine 0.1 mg/kg</description>
    <arm_group_label>Control Group</arm_group_label>
    <other_name>Group A</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age of the patients between 20 to 80 years.&#xD;
&#xD;
          -  ASA physical status II -III&#xD;
&#xD;
          -  Elective bladder cancer operations.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient refusal&#xD;
&#xD;
          -  Local infection at the site of injection&#xD;
&#xD;
          -  Allergy to study medications&#xD;
&#xD;
          -  Sepsis&#xD;
&#xD;
          -  Anatomic abnormalities&#xD;
&#xD;
          -  Systemic anticoagulation or coagulopathy&#xD;
&#xD;
          -  Inability to comprehend or participate in pain scoring system&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmed M Mohammed, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistant lecturer of Anesthesia, ICU, and Pain Relief</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ahmed M Mohammed, MSc</last_name>
    <phone>+20 122 431 8828</phone>
    <email>mans.cerano@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>National Cancer Institute - Egypt</name>
      <address>
        <city>Cairo</city>
        <zip>11796</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Atef Badran, PhD</last_name>
      <phone>0020101200155</phone>
      <email>atef.badran@nci.cu.edu.eg</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>April 18, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>October 15, 2020</last_update_submitted>
  <last_update_submitted_qc>October 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Bladder Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Analgesics, Opioid</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>I don't want to share</ipd_description>
  </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/NCT04402411
org study id: 201617049.3
nct id: NCT04402411
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Transversus abdominis plane (TAP) block can be used to provide effective analgesia during the
      postoperative period following a range of surgeries.

      TAP block administers local anesthetics between the T6 to L1 spinal nerve roots to stop the
      nerve signal and to alleviate pain for abdominal procedures 4, 5.

      The viscera are innervated by the vagal nerve (parasympathetic innervation) and by the
      splanchnic nerves (sympathetic innervation). The splanchnic nerves carry both visceral
      efferent and afferent nerve fibers. The sensory (or afferent) part of the splanchnic nerves
      reach the spinal column at certain spinal segments, It is possible to block central visceral
      pain conduction with thoracic paravertebral blockade or maybe even with the novel quadratus
      lumborum (QL) block.

      The effect of the QL block is believed to result from a spread of LA from its lumbar
      deposition cranially into the thoracic paravertebral space (TPVS), since Carney et al found
      traces of contrast agent in the TPVS following application of this block. Hence, the QL block
      would seem to be able to alleviate both somatic and visceral pain.10

      The aim of this study is to compare between quadratus lumborum block, transversus abdominis
      plane block regarding perioperative analgesia after bladder cancer surgeries by measuring
      intraoperative hemodynamics, postoperative pain scores and morphine consumption in the first
      24 h postoperative.
Somatic post-surgical pain is very distressing to patients which leads to important
      complications. Combined multimodal strategies involving nerve blocks, neuroaxial blocks,
      opiates, and non-steroidal anti-inflammatory drugs are necessary for optimal pain control.

      Transversus abdominis plane (TAP) block can be used to provide effective analgesia during the
      postoperative period following a range of surgeries.

      TAP block administers local anesthetics between the T6 to L1 spinal nerve roots to stop the
      nerve signal and to alleviate pain for abdominal procedures.

      A number of systematic reviews have assessed TAP block as a postoperative analgesic compared
      to one or more specific procedures.

      Anterior abdominal wall blocks, as transverse abdominal plexus block, have an important role
      for only somatic intraoperative and postoperative pain control.

      The viscera are innervated by the vagal nerve (parasympathetic innervation) and by the
      splanchnic nerves (sympathetic innervation). The splanchnic nerves carry both visceral
      efferent and afferent nerve fibers. The sensory (or afferent) part of the splanchnic nerves
      reach the spinal column at certain spinal segments, It is possible to block central visceral
      pain conduction with thoracic paravertebral blockade or maybe even with the novel quadratus
      lumborum (QL) block.

      The effect of the QL block is believed to result from a spread of LA from its lumbar
      deposition cranially into the thoracic paravertebral space (TPVS), since Carney et al found
      traces of contrast agent in the TPVS following application of this block. Hence, the QL block
      would seem to be able to alleviate both somatic and visceral pain.10 Quadratus lumborum block
      was first described by Blanco in 2007. Blanco described a potential space posterior to the
      abdominal wall muscles and lateral to the quadratus lumborum muscle. It has been used in
      abdominoplasties, caesarean sections and lower abdominal operations providing complete pain
      relief in the distribution area from Th6 to L1 dermatomes. It may be seen as a lumbar
      approach to the Thoracic Paravertebral Space. The block apparently produces distribution of
      the local anesthetic extending proximally and over both sides of the surface of the QL
      muscle, in between the anterior and intermediate layers of the thoracolumbar fascia.

      Quadratus lumborum muscle inserts on the lower border of the last rib and by four small
      tendons into the apices of the transverse processes of the upper four lumbar vertebrae.

      Running between its fascia and the muscle are the twelfth thoracic (subcostal), ilioinguinal,
      and iliohypogastric nerves, The block does not rely on the feeling of any pops or fascial
      clicks because depending of the angle of the needle several pops can be felt without reaching
      the target zone, which is lateral to the quadratus lumborum muscle. Actually, the block has
      never been intended to be conducted without the use of US guidance, and the block is thus a
      purely USG block.

      Aim of study Comparison between quadratus lumborum block, transversus abdominis plane block
      regarding perioperative analgesia after bladder cancer surgeries by measuring intraoperative
      hemodynamics, postoperative pain scores and morphine consumption in the first 24 h
      postoperative.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Time to first rescue dose of morphine
time frame: 24 hours
description: First time at which morphine was given postoperatively (If Vsual analogue scale (VAS) was >4, 3 mg morphine IV was administered as a rescue analgesia for the first 24 hours)
measure: Total dose of postoperative morphine consumption
time frame: 24 hours
description: Postoperative analgesia was provided by 1 gm paracetamol IV every 8 hours as a routine analgesia and if VAS was >4, 3 mg morphine IV was administered as a rescue analgesia for the first 24 hours.
measure: Pain intensity by visual analogue scale (VAS)
time frame: 24 hours
description: Visual analogue scale (VAS) was recorded at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24 hours postoperative.
(0: No pain, 1-3: Mild pain, 4-6: Moderate pain, 7-9: Severe pain and 10: The worst imaginable pain) Minimum:0 and Maximum 10 The higher, the worst
arm group label: Control Group
arm group type: Active Comparator
description: Patients will receive general anesthesia with intravenous opioid
arm group label: Quadratus lumborum
arm group type: Experimental
description: Patients will receive bilateral quadratus lumborum block
arm group label: Transversus abdominis plane
arm group type: Experimental
description: Patients will receive bilateral transversus abdominis plane block
intervention type: Procedure
intervention name: Quadratus lumborum block
description: The patient will be placed in a lateral position with the side to be blocked facing upwards. The ultrasound probe will be properly sterilized and with sterile covers. An 18-20 gauge blunt tipped block needle or a Tuohy needle is advanced under ultrasound guidance on the posterior aspect of the Quadratus Lumborum. The QL muscle is identified with its attachment to the lateral edge of the transverse process of the L4 vertebral body. With the psoas major muscle anteriorly, the erector spinae muscle posteriorly and the QL muscle adherent to the apex of the transverse process, a well recognisable pattern of a shamrock with three leaves can be seen.
arm group label: Quadratus lumborum
other name: Group B
intervention type: Procedure
intervention name: Transversus abdominis plane block
description: The patient will be supine while performing the block and sterilization of the site of the ultrasound and needle entry will be performed.
The ultrasound probe is placed in a transverse plane to the lateral abdominal wall in the midaxillary line, between the lower costal margin and iliac crest.
The needle is introduced in plane of the ultrasound probe directly under the probe and advanced until it reaches the plane between the internal oblique and transversus abdominis muscles.
arm group label: Transversus abdominis plane
other name: Group C
intervention type: Drug
intervention name: Intravenous opioid
description: Patients will receive morphine 0.1 mg/kg
arm group label: Control Group
other name: Group A
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Ahmed M Mohammed, MSc
role: Principal Investigator
affiliation: Assistant lecturer of Anesthesia, ICU, and Pain Relief
last name: Ahmed M Mohammed, MSc
phone: +20 122 431 8828
email: mans.cerano@gmail.com
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Sponsor
mesh term: Urinary Bladder Neoplasms
mesh term: Analgesics, Opioid
sharing ipd: No
ipd description: I don't want to share