<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/NCT04459624</url>
  </required_header>
  <id_info>
    <org_study_id>ESOGU 2</org_study_id>
    <nct_id>NCT04459624</nct_id>
  </id_info>
  <brief_title>Comparison of Quadratus Lumborum Block and Erector Spina Plane Block in Nephrectomy</brief_title>
  <official_title>Comparison of the Effects of Quadratus Lumborum Block (QLB) and Erector Spina Plane Block (ESP) on Postoperative Pain in Open Nephrectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eskisehir Osmangazi University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eskisehir Osmangazi 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>
      Postoperative pain is important due to the limitation of physical functions, delay in&#xD;
      recovery of quality of life, long-term opiate use, length of hospital stay, increased care&#xD;
      costs and early postoperative pain trigger chronic pain. It is associated with postoperative&#xD;
      morbidity. Multimodal analgesia techniques with fascial plan blocks are frequently used.The&#xD;
      investigators aimed to evaluate the effect of QLB2 and ESP on postoperative pain scores in&#xD;
      nephrectomy surgery, total opiate consumption, initial analgesia requirement, additional&#xD;
      analgesia consumption, patient and surgeon satisfaction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      At the end of the operation, patients will be randomly divided into 2 groups as Group E (ESP&#xD;
      block) and Group Q (QLB). The blocks will be administered under general anesthesia in lateral&#xD;
      position by same anesthesiologist. Group E (ESP block) will be applied 20 ml of %0.25&#xD;
      bupivacaine between the erector spina muscle and transverse process at the 8th thoracic&#xD;
      level. Group Q (QLB2 block) will be applied 20 ml of %0.25 bupivacaine at lumbar interfacial&#xD;
      triangle (LIFT). At the end of the operation, the patients with a Modified aldreate score ≥9&#xD;
      will be sent from the postoperative anesthesia unit. All patients will be equipped with an IV&#xD;
      morphine patient-controlled analgesia (PCA) device. The solution will be prepared such that&#xD;
      morphine is 0.5 mg / ml. PCA 1mg bolus dose will be delivered with 10 min lock-out time. In&#xD;
      the postoperative period, the patient was evaluated by another researcher who blind to the&#xD;
      groups at the 1st and 6th, 12th and 24th hours. Visual pain scores (VAS) in rest and&#xD;
      movement, hemodynamic values, morphine consumption, initial analgesic requirement,&#xD;
      nausea-vomiting score, ramsey sedation scale, length of hospital stay, patient and surgeon&#xD;
      satisfaction, and postoperative complications will be recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 20, 2020</start_date>
  <completion_date type="Actual">January 31, 2022</completion_date>
  <primary_completion_date type="Actual">July 20, 2021</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>
    <intervention_model_description>Group E: ESP block will be applied at the end of the operation. Patients will receive paracetamol 1gr 4 * 1 and tramadol 1mg/kg 30 minutes before the end of the operation. All patients will undergo IV morphine patient-controlled analgesia (PCA). Pain, opioid consumption, hemodynamic parameters and complications will be monitored in the first 24 hours in the postoperative period.&#xD;
Group Q: QLB2 block will be applied at the end of the operation. Patients will receive paracetamol 1gr 4 * 1 and tramadol 1mg / kg 30 minutes before the end of the operation. All patients will undergo IV morphine patient-controlled analgesia (PCA). Pain, opioid consumption, hemodynamic parameters and complications will be monitored in the first 24 hours in the postoperative period.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>In the postoperative period, the effectiveness and safety of the block will be evaluated by another researcher (blind) who does not know which group the patient is in.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Effect of QLB2 and ESP on postoperative pain scores in nephrectomy surgery</measure>
    <time_frame>24 hours</time_frame>
    <description>Visual analog scale at rest and movement (0 (no pain)-10 (unbearable pain))</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total opiate consumption</measure>
    <time_frame>24 hours</time_frame>
    <description>Total morphine patient control analgesia prepared 0.5 mg / ml. PCA 1mg bolus dose will be delivered with 10 min lock-out time. Follow up morphine consumption at postoperative 24 hours</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Pain, Postoperative</condition>
  <condition>Postoperative Complications</condition>
  <arm_group>
    <arm_group_label>ESP block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention: Erector Spina Plane Block will administer with 20 ml of % 0.25 bupivacaine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>QLB 2 block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention: Quadratus Lumborum Block 2 will administer with 20 ml of % 0.25 bupivacaine</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Erector Spina Plane Block</intervention_name>
    <description>Group E (ESP block) will be applied 20 ml of % 0.25 bupivacaine between the erector spina muscle and transverse process at the 8th thoracic level. The blocks will be administered under general anesthesia in lateral position by the same anesthesiologist.</description>
    <arm_group_label>ESP block</arm_group_label>
    <other_name>Fascial plane block at nephrectomy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Quadratus Lumborum Block 2</intervention_name>
    <description>Group Q (QLB2 block) lumbar interfacial triangle (LIFT) will be applied 20 ml of % 0.25 bupivacaine. The blocks will be administered under general anesthesia in lateral position by the same anesthesiologist.</description>
    <arm_group_label>QLB 2 block</arm_group_label>
    <other_name>Fascial plane block at nephrectomy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Partial or radical nephrectomy&#xD;
&#xD;
          -  American Society of Anesthesiologist physical status I-III&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Infection in the incision area&#xD;
&#xD;
          -  Coagulation disorder&#xD;
&#xD;
          -  Known allergy history against to the study drugs&#xD;
&#xD;
          -  Lack of adequate cognitive activity in the use of patient-controlled analgesia and VAS&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Meryem Onay, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Eskisehir Osmangazi University Faculty Of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Eskisehir Osmangazi Univercıty</name>
      <address>
        <city>Odunpazarı</city>
        <state>Eskisehir</state>
        <zip>26040</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Aksu C, Sen MC, Akay MA, Baydemir C, Gurkan Y. Erector Spinae Plane Block vs Quadratus Lumborum Block for pediatric lower abdominal surgery: A double blinded, prospective, and randomized trial. J Clin Anesth. 2019 Nov;57:24-28. doi: 10.1016/j.jclinane.2019.03.006. Epub 2019 Mar 6.</citation>
    <PMID>30851499</PMID>
  </reference>
  <reference>
    <citation>Ueshima H, Otake H, Lin JA. Ultrasound-Guided Quadratus Lumborum Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:2752876. doi: 10.1155/2017/2752876. Epub 2017 Jan 3.</citation>
    <PMID>28154824</PMID>
  </reference>
  <reference>
    <citation>Oksuz G, Bilal B, Gurkan Y, Urfalioglu A, Arslan M, Gisi G, Oksuz H. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block in Children Undergoing Low Abdominal Surgery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2017 Sep/Oct;42(5):674-679. doi: 10.1097/AAP.0000000000000645.</citation>
    <PMID>28759502</PMID>
  </reference>
  <reference>
    <citation>Yousef NK. Quadratus Lumborum Block versus Transversus Abdominis Plane Block in Patients Undergoing Total Abdominal Hysterectomy: A Randomized Prospective Controlled Trial. Anesth Essays Res. 2018 Jul-Sep;12(3):742-747. doi: 10.4103/aer.AER_108_18.</citation>
    <PMID>30283187</PMID>
  </reference>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>February 3, 2022</last_update_submitted>
  <last_update_submitted_qc>February 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Eskisehir Osmangazi University</investigator_affiliation>
    <investigator_full_name>Meryem Onay</investigator_full_name>
    <investigator_title>Specialist Doctor-Anesthesiologist</investigator_title>
  </responsible_party>
  <keyword>Erector Spina Plan Block</keyword>
  <keyword>Quadratus Lumborum Block</keyword>
  <keyword>Nephrectomy</keyword>
  <keyword>Postoperative Pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
    <mesh_term>Postoperative Complications</mesh_term>
  </condition_browse>
  <!-- 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/NCT04459624
org study id: ESOGU 2
nct id: NCT04459624
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Postoperative pain is important due to the limitation of physical functions, delay in
      recovery of quality of life, long-term opiate use, length of hospital stay, increased care
      costs and early postoperative pain trigger chronic pain. It is associated with postoperative
      morbidity. Multimodal analgesia techniques with fascial plan blocks are frequently used.The
      investigators aimed to evaluate the effect of QLB2 and ESP on postoperative pain scores in
      nephrectomy surgery, total opiate consumption, initial analgesia requirement, additional
      analgesia consumption, patient and surgeon satisfaction.
At the end of the operation, patients will be randomly divided into 2 groups as Group E (ESP
      block) and Group Q (QLB). The blocks will be administered under general anesthesia in lateral
      position by same anesthesiologist. Group E (ESP block) will be applied 20 ml of %0.25
      bupivacaine between the erector spina muscle and transverse process at the 8th thoracic
      level. Group Q (QLB2 block) will be applied 20 ml of %0.25 bupivacaine at lumbar interfacial
      triangle (LIFT). At the end of the operation, the patients with a Modified aldreate score ≥9
      will be sent from the postoperative anesthesia unit. All patients will be equipped with an IV
      morphine patient-controlled analgesia (PCA) device. The solution will be prepared such that
      morphine is 0.5 mg / ml. PCA 1mg bolus dose will be delivered with 10 min lock-out time. In
      the postoperative period, the patient was evaluated by another researcher who blind to the
      groups at the 1st and 6th, 12th and 24th hours. Visual pain scores (VAS) in rest and
      movement, hemodynamic values, morphine consumption, initial analgesic requirement,
      nausea-vomiting score, ramsey sedation scale, length of hospital stay, patient and surgeon
      satisfaction, and postoperative complications will be recorded.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Group E: ESP block will be applied at the end of the operation. Patients will receive paracetamol 1gr 4 * 1 and tramadol 1mg/kg 30 minutes before the end of the operation. All patients will undergo IV morphine patient-controlled analgesia (PCA). Pain, opioid consumption, hemodynamic parameters and complications will be monitored in the first 24 hours in the postoperative period.
Group Q: QLB2 block will be applied at the end of the operation. Patients will receive paracetamol 1gr 4 * 1 and tramadol 1mg / kg 30 minutes before the end of the operation. All patients will undergo IV morphine patient-controlled analgesia (PCA). Pain, opioid consumption, hemodynamic parameters and complications will be monitored in the first 24 hours in the postoperative period.
primary purpose: Other
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: In the postoperative period, the effectiveness and safety of the block will be evaluated by another researcher (blind) who does not know which group the patient is in.
measure: Effect of QLB2 and ESP on postoperative pain scores in nephrectomy surgery
time frame: 24 hours
description: Visual analog scale at rest and movement (0 (no pain)-10 (unbearable pain))
measure: Total opiate consumption
time frame: 24 hours
description: Total morphine patient control analgesia prepared 0.5 mg / ml. PCA 1mg bolus dose will be delivered with 10 min lock-out time. Follow up morphine consumption at postoperative 24 hours
arm group label: ESP block
arm group type: Active Comparator
description: Intervention: Erector Spina Plane Block will administer with 20 ml of % 0.25 bupivacaine
arm group label: QLB 2 block
arm group type: Active Comparator
description: Intervention: Quadratus Lumborum Block 2 will administer with 20 ml of % 0.25 bupivacaine
intervention type: Procedure
intervention name: Erector Spina Plane Block
description: Group E (ESP block) will be applied 20 ml of % 0.25 bupivacaine between the erector spina muscle and transverse process at the 8th thoracic level. The blocks will be administered under general anesthesia in lateral position by the same anesthesiologist.
arm group label: ESP block
other name: Fascial plane block at nephrectomy
intervention type: Procedure
intervention name: Quadratus Lumborum Block 2
description: Group Q (QLB2 block) lumbar interfacial triangle (LIFT) will be applied 20 ml of % 0.25 bupivacaine. The blocks will be administered under general anesthesia in lateral position by the same anesthesiologist.
arm group label: QLB 2 block
other name: Fascial plane block at nephrectomy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Meryem Onay, Dr
role: Principal Investigator
affiliation: Eskisehir Osmangazi University Faculty Of Medicine
facility: 
country: Turkey
citation: Aksu C, Sen MC, Akay MA, Baydemir C, Gurkan Y. Erector Spinae Plane Block vs Quadratus Lumborum Block for pediatric lower abdominal surgery: A double blinded, prospective, and randomized trial. J Clin Anesth. 2019 Nov;57:24-28. doi: 10.1016/j.jclinane.2019.03.006. Epub 2019 Mar 6.
PMID: 30851499
citation: Ueshima H, Otake H, Lin JA. Ultrasound-Guided Quadratus Lumborum Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:2752876. doi: 10.1155/2017/2752876. Epub 2017 Jan 3.
PMID: 28154824
citation: Oksuz G, Bilal B, Gurkan Y, Urfalioglu A, Arslan M, Gisi G, Oksuz H. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block in Children Undergoing Low Abdominal Surgery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2017 Sep/Oct;42(5):674-679. doi: 10.1097/AAP.0000000000000645.
PMID: 28759502
citation: Yousef NK. Quadratus Lumborum Block versus Transversus Abdominis Plane Block in Patients Undergoing Total Abdominal Hysterectomy: A Randomized Prospective Controlled Trial. Anesth Essays Res. 2018 Jul-Sep;12(3):742-747. doi: 10.4103/aer.AER_108_18.
PMID: 30283187
responsible party type: Principal Investigator
investigator affiliation: Eskisehir Osmangazi University
investigator full name: Meryem Onay
investigator title: Specialist Doctor-Anesthesiologist
mesh term: Pain, Postoperative
mesh term: Postoperative Complications