<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/NCT03803267</url>
  </required_header>
  <id_info>
    <org_study_id>MD.18.11.106</org_study_id>
    <nct_id>NCT03803267</nct_id>
  </id_info>
  <brief_title>Analgesia of Erector Spinae Plane Block Versus Quadratus Lumborum Block</brief_title>
  <official_title>A Comparative Study of Analgesic Effect of Ultrasound Guided Erector Spinae Plane Block Versus Quadratus Lumborum Block for Open Colorectal Cancer Surgeries</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mansoura University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mansoura University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Colorectal cancer is the third most common cancer worldwide. These patients usually undergo&#xD;
      open surgical resection of cancer under general anaesthesia.&#xD;
&#xD;
      The aim of this study is to detect whether the Erector spinae plan block or Quadratus&#xD;
      lumborum block will provide the most ideal analgesia for these patients. Erector spinae plan&#xD;
      block is a novel analgesic technique that provides both visceral and somatic analgesia due to&#xD;
      its communication with the paravertebral space. Quadratus lumborum block is a truncal nerve&#xD;
      block usually used for intra-abdominal surgeries. Ultrasound guidance increases the accuracy&#xD;
      and safety of both techniques. A local anaesthetic mixture of Bupivacaine 0.25% and&#xD;
      dexamethasone will be used for both techniques.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Erector spinae plane block and quadratus lumborum block are analgesic techniques suitable for&#xD;
      open colorectal cancer surgeries. postoperative pain score, serum levels of biomarkers of&#xD;
      stress (cortisol and CRP), primary hemodynamics, time to first rescue analgesic request, the&#xD;
      total amount of rescue analgesic consumption and postoperative nausea and vomiting are the&#xD;
      parameters of comparison between both techniques.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2019</start_date>
  <completion_date type="Actual">April 1, 2020</completion_date>
  <primary_completion_date type="Actual">January 1, 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>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Single blind (participant) study</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative pain score</measure>
    <time_frame>From 1 day before the surgery to the 2 days after surgery</time_frame>
    <description>The intensity of pain indicated by a segmented numeric scale in which a respondent selects a whole number (0-100 integers) that best reflects his/her pain as 0-30 for mild pain, 30-60 for moderate pain and 60-100 for sever pain</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Systolic Blood Pressure</measure>
    <time_frame>One hour before induction of general anesthesia, every 10 minutes till end of surgery, every 4 hours till end of the first 24 hours postoperatively, then every 8 hours till end of the next 24 hours</time_frame>
    <description>The pressure in the arteries during contraction of the heart</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Blood Pressure</measure>
    <time_frame>One hour before induction of general anesthesia, every 10 minutes till end of surgery, every 4 hours till end of the first 24 hours postoperatively, then every 8 hours till end of the next 24 hours</time_frame>
    <description>: The average pressure in the arteries during one cardiac cycle. It is a better indicator for vital organs' perfusion than the systolic pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate</measure>
    <time_frame>One hour before induction of general anesthesia, every 10 minutes till end of surgery, every 4 hours till end of the first 24 hours postoperatively, then every 8 hours till end of the next 24 hours</time_frame>
    <description>The number of heart beats per minute. A lower heart rate at rest implies a more efficient heart function, better cardiovascular fitness and less stress</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first rescue analgesic request</measure>
    <time_frame>Up to 48 postoperative hours</time_frame>
    <description>The time elapsed from termination of performing each block till the patient's request for analgesia. It resembles the duration of analgesia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peripheral oxygen saturation</measure>
    <time_frame>One hour before induction of general anesthesia, every 10 minutes till end of surgery, every 4 hours till end of the first 24 hours postoperatively, then every 8 hours till end of the next 24 hours</time_frame>
    <description>An estimate of oxygenated hemoglobin concentration in blood. It is measured by pulse oximeter device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total amount of rescue analgesic consumption</measure>
    <time_frame>From the time of first analgesic request till the end of the first 24 hours, then till the end of the next 24 hours postoperatively</time_frame>
    <description>The total amount of morphine consumed by the patient for pain relief over the 48 hours postoperatively</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative nausea and vomiting intensity score</measure>
    <time_frame>Immediately after recovery, every 4 hours till end of the first 24 hours postoperatively, then every 8 hours till end of the next 24 hours</time_frame>
    <description>Postoperative Nausea and Vomiting Intensity Scale: A scale that evaluates postoperative nausea and vomiting. It equals severity of nausea (1=mild, 2= moderate, 3= sever) x pattern of nausea (1=varying, 2= constant) x duration of nausea (in hours). At any time, if it is &lt; 50 or vomiting occurs once or twice, it is clinically unimportant (good outcome). If it is ≥50 or vomiting occurs 3 or more times, it is clinically important (bad outcome). The sum of all values will quantify the entire period of the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cortisol</measure>
    <time_frame>At 9 Am, 1 hour after induction of general anesthesia, 1st, 24th and 48th hours postoperatively</time_frame>
    <description>A steroid hormone secreted by adrenal cortex in response to stress and hypoglycemia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum C-reactive protein (CRP)</measure>
    <time_frame>On hospital admission, 1 hour after induction of general anesthesia, 1st, 24th and 48th hours postoperatively</time_frame>
    <description>A protein synthetized by hepatocytes in response to systemic inflammation or tissue damage</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">68</enrollment>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>Erector spinae plane block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive bilateral ultrasound-guided erector spinae plane block as an adjuvant analgesic technique</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Quadratus lumborum block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive bilateral ultrasound-guided quadratus lumborum block as an adjuvant analgesic technique</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Erector spinae plane block</intervention_name>
    <description>For each side, the eighth thoracic transverse process will be identified by a linear US transducer (HFL38_10-5 MHz), puncture will be performed in the plane in the craniocaudal direction until the needle contacts the transverse process, and 20 ml of bupivacaine 0.25% and 4 mg dexamethasone will be injected visualizing the hydrodissection. After 30 minutes, the degree of sensory block in the trunk will be assessed by the pinprick test and any undesirable motor weakness will be recorded as a side effect.</description>
    <arm_group_label>Erector spinae plane block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Quadratus lumborum block</intervention_name>
    <description>For each side, shamrock sign with three leaves (psoas major muscle anteriorly, the erector spinae muscle posteriorly and the quadratus lumborum muscle adherent to the apex of the transverse process of the L4 vertebral body) will be identified by a curved array US transducer (6-2MHz), puncture will be performed in-plane, the needle will be advanced through the quadratus lumborum muscle penetrating the ventral proper fascia of the quadratus lumborum muscle, and 20 mL of bupivacaine 0.25% and 4 mg dexamethasone will be injected in that space visualizing the hydrodissection. After 30 minutes, the degree of sensory block in the trunk will be assessed by the pinprick test and any undesired motor weakness will be recorded as a side effect</description>
    <arm_group_label>Quadratus lumborum block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propofol</intervention_name>
    <description>Propofol (2 mg/kg)</description>
    <arm_group_label>Erector spinae plane block</arm_group_label>
    <arm_group_label>Quadratus lumborum block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fentanyl NCS</intervention_name>
    <description>Fentanyl (1µg/Kg)</description>
    <arm_group_label>Erector spinae plane block</arm_group_label>
    <arm_group_label>Quadratus lumborum block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atracurium Injectable Product</intervention_name>
    <description>atracurium (0.5mg/kg)</description>
    <arm_group_label>Erector spinae plane block</arm_group_label>
    <arm_group_label>Quadratus lumborum block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Endotracheal intubation</intervention_name>
    <description>endotracheal intubation</description>
    <arm_group_label>Erector spinae plane block</arm_group_label>
    <arm_group_label>Quadratus lumborum block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Anesthesia Maintenance</intervention_name>
    <description>Inhalational isoflurane in oxygen/air mixture</description>
    <arm_group_label>Erector spinae plane block</arm_group_label>
    <arm_group_label>Quadratus lumborum block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Muscle Relaxation</intervention_name>
    <description>atracurium boluses (0.2 mg/Kg/20 minutes) will be used for maintenance of general anesthesia</description>
    <arm_group_label>Erector spinae plane block</arm_group_label>
    <arm_group_label>Quadratus lumborum block</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists physical status I or II&#xD;
&#xD;
          -  Body mass index from 18.5 to 35 Kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Body mass index more than 35 Kg/m2.&#xD;
&#xD;
          -  Severe or uncompensated cardiovascular disease.&#xD;
&#xD;
          -  Severe renal disease.&#xD;
&#xD;
          -  Severe hepatic disease.&#xD;
&#xD;
          -  Severe endocrinal disease.&#xD;
&#xD;
          -  Pregnancy.&#xD;
&#xD;
          -  Postpartum.&#xD;
&#xD;
          -  Lactating females&#xD;
&#xD;
          -  Allergy to one of the agents used.&#xD;
&#xD;
          -  Refusal to participate in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amer A Attieh, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Professor</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mohammed A Ghanem, MD</last_name>
    <role>Study Director</role>
    <affiliation>Associate Professor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Amer A Attieh</name>
      <address>
        <city>Mansourah</city>
        <state>DK</state>
        <zip>050</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>April 1, 2020</last_update_submitted>
  <last_update_submitted_qc>April 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 3, 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>Colorectal Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fentanyl</mesh_term>
    <mesh_term>Propofol</mesh_term>
    <mesh_term>Atracurium</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03803267
org study id: MD.18.11.106
nct id: NCT03803267
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Colorectal cancer is the third most common cancer worldwide. These patients usually undergo
      open surgical resection of cancer under general anaesthesia.

      The aim of this study is to detect whether the Erector spinae plan block or Quadratus
      lumborum block will provide the most ideal analgesia for these patients. Erector spinae plan
      block is a novel analgesic technique that provides both visceral and somatic analgesia due to
      its communication with the paravertebral space. Quadratus lumborum block is a truncal nerve
      block usually used for intra-abdominal surgeries. Ultrasound guidance increases the accuracy
      and safety of both techniques. A local anaesthetic mixture of Bupivacaine 0.25% and
      dexamethasone will be used for both techniques.
Erector spinae plane block and quadratus lumborum block are analgesic techniques suitable for
      open colorectal cancer surgeries. postoperative pain score, serum levels of biomarkers of
      stress (cortisol and CRP), primary hemodynamics, time to first rescue analgesic request, the
      total amount of rescue analgesic consumption and postoperative nausea and vomiting are the
      parameters of comparison between both techniques.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Participant)
masking description: Single blind (participant) study
measure: Postoperative pain score
time frame: From 1 day before the surgery to the 2 days after surgery
description: The intensity of pain indicated by a segmented numeric scale in which a respondent selects a whole number (0-100 integers) that best reflects his/her pain as 0-30 for mild pain, 30-60 for moderate pain and 60-100 for sever pain
measure: Systolic Blood Pressure
time frame: One hour before induction of general anesthesia, every 10 minutes till end of surgery, every 4 hours till end of the first 24 hours postoperatively, then every 8 hours till end of the next 24 hours
description: The pressure in the arteries during contraction of the heart
measure: Mean Blood Pressure
time frame: One hour before induction of general anesthesia, every 10 minutes till end of surgery, every 4 hours till end of the first 24 hours postoperatively, then every 8 hours till end of the next 24 hours
description: : The average pressure in the arteries during one cardiac cycle. It is a better indicator for vital organs' perfusion than the systolic pressure
measure: Heart rate
time frame: One hour before induction of general anesthesia, every 10 minutes till end of surgery, every 4 hours till end of the first 24 hours postoperatively, then every 8 hours till end of the next 24 hours
description: The number of heart beats per minute. A lower heart rate at rest implies a more efficient heart function, better cardiovascular fitness and less stress
measure: Time to first rescue analgesic request
time frame: Up to 48 postoperative hours
description: The time elapsed from termination of performing each block till the patient's request for analgesia. It resembles the duration of analgesia
measure: Peripheral oxygen saturation
time frame: One hour before induction of general anesthesia, every 10 minutes till end of surgery, every 4 hours till end of the first 24 hours postoperatively, then every 8 hours till end of the next 24 hours
description: An estimate of oxygenated hemoglobin concentration in blood. It is measured by pulse oximeter device
measure: Total amount of rescue analgesic consumption
time frame: From the time of first analgesic request till the end of the first 24 hours, then till the end of the next 24 hours postoperatively
description: The total amount of morphine consumed by the patient for pain relief over the 48 hours postoperatively
measure: Postoperative nausea and vomiting intensity score
time frame: Immediately after recovery, every 4 hours till end of the first 24 hours postoperatively, then every 8 hours till end of the next 24 hours
description: Postoperative Nausea and Vomiting Intensity Scale: A scale that evaluates postoperative nausea and vomiting. It equals severity of nausea (1=mild, 2= moderate, 3= sever) x pattern of nausea (1=varying, 2= constant) x duration of nausea (in hours). At any time, if it is < 50 or vomiting occurs once or twice, it is clinically unimportant (good outcome). If it is ≥50 or vomiting occurs 3 or more times, it is clinically important (bad outcome). The sum of all values will quantify the entire period of the study.
measure: Cortisol
time frame: At 9 Am, 1 hour after induction of general anesthesia, 1st, 24th and 48th hours postoperatively
description: A steroid hormone secreted by adrenal cortex in response to stress and hypoglycemia
measure: Serum C-reactive protein (CRP)
time frame: On hospital admission, 1 hour after induction of general anesthesia, 1st, 24th and 48th hours postoperatively
description: A protein synthetized by hepatocytes in response to systemic inflammation or tissue damage
arm group label: Erector spinae plane block
arm group type: Active Comparator
description: Patients will receive bilateral ultrasound-guided erector spinae plane block as an adjuvant analgesic technique
arm group label: Quadratus lumborum block
arm group type: Active Comparator
description: Patients will receive bilateral ultrasound-guided quadratus lumborum block as an adjuvant analgesic technique
intervention type: Other
intervention name: Erector spinae plane block
description: For each side, the eighth thoracic transverse process will be identified by a linear US transducer (HFL38_10-5 MHz), puncture will be performed in the plane in the craniocaudal direction until the needle contacts the transverse process, and 20 ml of bupivacaine 0.25% and 4 mg dexamethasone will be injected visualizing the hydrodissection. After 30 minutes, the degree of sensory block in the trunk will be assessed by the pinprick test and any undesirable motor weakness will be recorded as a side effect.
arm group label: Erector spinae plane block
intervention type: Other
intervention name: Quadratus lumborum block
description: For each side, shamrock sign with three leaves (psoas major muscle anteriorly, the erector spinae muscle posteriorly and the quadratus lumborum muscle adherent to the apex of the transverse process of the L4 vertebral body) will be identified by a curved array US transducer (6-2MHz), puncture will be performed in-plane, the needle will be advanced through the quadratus lumborum muscle penetrating the ventral proper fascia of the quadratus lumborum muscle, and 20 mL of bupivacaine 0.25% and 4 mg dexamethasone will be injected in that space visualizing the hydrodissection. After 30 minutes, the degree of sensory block in the trunk will be assessed by the pinprick test and any undesired motor weakness will be recorded as a side effect
arm group label: Quadratus lumborum block
intervention type: Drug
intervention name: Propofol
description: Propofol (2 mg/kg)
arm group label: Erector spinae plane block
arm group label: Quadratus lumborum block
intervention type: Drug
intervention name: Fentanyl NCS
description: Fentanyl (1µg/Kg)
arm group label: Erector spinae plane block
arm group label: Quadratus lumborum block
intervention type: Drug
intervention name: Atracurium Injectable Product
description: atracurium (0.5mg/kg)
arm group label: Erector spinae plane block
arm group label: Quadratus lumborum block
intervention type: Other
intervention name: Endotracheal intubation
description: endotracheal intubation
arm group label: Erector spinae plane block
arm group label: Quadratus lumborum block
intervention type: Drug
intervention name: Anesthesia Maintenance
description: Inhalational isoflurane in oxygen/air mixture
arm group label: Erector spinae plane block
arm group label: Quadratus lumborum block
intervention type: Drug
intervention name: Muscle Relaxation
description: atracurium boluses (0.2 mg/Kg/20 minutes) will be used for maintenance of general anesthesia
arm group label: Erector spinae plane block
arm group label: Quadratus lumborum block
criteria: 
gender: All
minimum age: 40 Years
maximum age: 60 Years
healthy volunteers: No
last name: Amer A Attieh, MD
role: Study Chair
affiliation: Professor
last name: Mohammed A Ghanem, MD
role: Study Director
affiliation: Associate Professor
facility: 
country: Egypt
responsible party type: Sponsor
mesh term: Colorectal Neoplasms
mesh term: Fentanyl
mesh term: Propofol
mesh term: Atracurium
sharing ipd: Undecided