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/NCT06028061</url>
    </required_header>
    <id_info>
      <org_study_id>GaziosmanpasaTREHBB</org_study_id>
      <nct_id>NCT06028061</nct_id>
    </id_info>
    <brief_title>Evaluation of Effectivity of Quadratus Lumborum Blocks With Adjuvant</brief_title>
    <acronym>AdjuvantQLB</acronym>
    <official_title>Evaluation of The Postoperative Analgesic Effectivity of Quadratus Lumborum Block III With Adjuvant on Patients Undergoing Laparoscopic Cholecystectomy Surgery : A Randomised Controled Study</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>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>
        İn recent years abdominal wall blocks are widely used for to reduce intraoperative anesthetic&#xD;
        recuirements and postoperative analgesia.Quadratus lumborum blocks are one of the abdominal&#xD;
        wall blocks to used at laparoscopic cholecystectomy.Conventionally adjuvants used to improve&#xD;
        and prolonged the effect of periferic nerve, spinal and abdominal blocks.İn this study&#xD;
        investigators will evaluate the effectiveness of adjuvants at quatratus lumborum block at&#xD;
        patient underwent laparoscopic cholecystectomy.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Laparoscopic approach in cholecystectomy surgery is frequently preferred because of its&#xD;
        advantages in systemic complications, morbidity, mortality and hospital stay. Pain is one of&#xD;
        the important causes of late discharge after surgery. Laparoscopic cholecystectomy surgery&#xD;
        requires a multimodal analgesia approach because of its multiple pain components.Regional&#xD;
        analgesia techniques are effective in reducing the side effects such as intraoperative opioid&#xD;
        use, postoperative pain and nausea and vomiting. Quadratus lumborum III block is a regional&#xD;
        technique performed for multimodal analgesia.Adjuvants are known to improve the analgesic&#xD;
        efficacy and prolonge the effect of the periferic and central nerve blocks.The aim of this&#xD;
        study is to determine the effectiveness of adding adjuvant at quadratus lumborum block for&#xD;
        patients who underwent laparoscopic cholecystectomy.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 12, 2023</start_date>
    <completion_date type="Anticipated">November 15, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 15, 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>Supportive Care</primary_purpose>
      <masking>Double (Participant, Care Provider)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Total amount of opioid requirements</measure>
      <time_frame>within 24 hours after the surgery</time_frame>
      <description>The total tramadol use of the patients in 24 hours will be recorded.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>rescue analgesia</measure>
      <time_frame>within 24 hours after the surgery</time_frame>
      <description>The rescue analgesia requirement and time of the need of the rescue analgesia requirement</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>intraoperative remifentanil consumption</measure>
      <time_frame>during operation procedure]</time_frame>
      <description>The total remifentanil use to be used in the maintenance of 0.05-0.2 mcg/kg remifentanil will be recorded by titration according to the hemodynamic data of the intraoperative patients.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Visual Analogue Scale values</measure>
      <time_frame>at 1st, 4th,8th 12th and 24th hours after the surgery]</time_frame>
      <description>Visual Analogue Scale is a scale of 0-10 cm in length, expressed by non-standard verbal descriptors (no pain-unbearable pain..) indicating the limits of pain intensity on both sides, horizontally or vertically.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>side effects such as nausea, vomiting and shoulder pain</measure>
      <time_frame>within 24 hours after the surgery</time_frame>
      <description>The incidence of postoperative side effects such as nausea, vomiting and shoulder pain will be evaluated.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Postoperative Pain Management</condition>
    <condition>Postoperative Pain</condition>
    <condition>Analgesia</condition>
    <condition>Nerve Blocks</condition>
    <condition>Nerve Block Duration</condition>
    <condition>Cholecystectomy</condition>
    <arm_group>
      <arm_group_label>Quadratus lumborum block</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients are placed in the lateral decubitus position. The area where the block will be applied is disinfected with povidine iodine. A convex ultrasound probe is placed on the midaxillary line above the iliac crest. By visualizing the transverse process adjacent to the psoas major and quadratus lumborum muscles, using the in-plane technique, using a 22 gauge 80 mm peripheral block needle after negative aspiration into the anterior layer of the thoracolumbar fascia anterior to the quadratus lumborum muscle muscle, 0.5-1 ml of serum After observing hydrodissection with physiological, 20 ml of 0.25% bupivacaine is injected. The same is done to the opposite side.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Quadratus Lumborum Block with adjuvant</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients are placed in the lateral decubitus position. The area where the block will be applied is disinfected with povidine iodine. A convex ultrasound probe is placed on the midaxillary line above the iliac crest. By visualizing the transverse process adjacent to the psoas major and quadratus lumborum muscles, using the in-plane technique, using a 22 gauge 80 mm peripheral block needle after negative aspiration into the anterior layer of the thoracolumbar fascia anterior to the quadratus lumborum muscle muscle, 0.5-1 ml of serum After observing hydrodissection with physiological, 20 ml of 0.25% bupivacaine and 4mg dexamethasone is injected. The same is done to the opposite side.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Quadratus Lumborum Block III</intervention_name>
      <description>Patients are placed in the lateral decubitus position. The area where the block will be applied is disinfected with povidine iodine. A convex ultrasound probe is placed on the midaxillary line above the iliac crest. By visualizing the transverse process adjacent to the psoas major and quadratus lumborum muscles, using the in-plane technique, using a 22 gauge 80 mm peripheral block needle after negative aspiration into the anterior layer of the thoracolumbar fascia anterior to the quadratus lumborum muscle muscle, 0.5-1 ml of serum After observing hydrodissection with physiological, 20 ml of 0.25% bupivacaine is injected. The same is done to the opposite side.</description>
      <arm_group_label>Quadratus lumborum block</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Quadratus lumborum block III with Adjuvant</intervention_name>
      <description>Patients are placed in the lateral decubitus position. The area where the block will be applied is disinfected with povidine iodine. A convex ultrasound probe is placed on the midaxillary line above the iliac crest. By visualizing the transverse process adjacent to the psoas major and quadratus lumborum muscles, using the in-plane technique, using a 22 gauge 80 mm peripheral block needle after negative aspiration into the anterior layer of the thoracolumbar fascia anterior to the quadratus lumborum muscle muscle, 0.5-1 ml of serum After observing hydrodissection with physiological, 20 ml of 0.25% bupivacaine and 4mg dexamethasone is injected. The same is done to the opposite side.</description>
      <arm_group_label>Quadratus Lumborum Block with adjuvant</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria: American Society of Anesthesiologists physical statusⅠ-II&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Inclusion Criteria:&#xD;
  &#xD;
            -  18-65 years of age&#xD;
  &#xD;
            -  American Society of Anesthesiologists physical statusⅠ-II&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  local anesthetic allergy&#xD;
  &#xD;
            -  Infection at the procedure site Body Mass Index &gt;35 kg/m2 Anticoagulant use with&#xD;
               bleeding disorder Chronic analgesia and opioid use with mental and psychiatric&#xD;
               disorders Contraindications to regional anesthesia several lung and heart disease&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>SERPİL SEHİRLİOGLU, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Gaziosmanpasa Research and Education Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>BATUHAN BURHAN, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Gaziosmanpasa Research and Education Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>DONDU GENC MORALAR, MD</last_name>
      <role>Study Director</role>
      <affiliation>Gaziosmanpasa Research and Education Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Serpil SEHİRLİOGLU, MD</last_name>
      <phone>+905054431852</phone>
      <email>drserpilsahin@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Batuhan BURHAN, MD</last_name>
      <phone>+905398740609</phone>
      <email>fenerlibatuhan@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Gaziosmanpasa Research and Education Hospital</name>
        <address>
          <city>İ̇stanbul</city>
          <state>Marmara</state>
          <zip>34255</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>SERPİL SEHİRLİOGLU, MD</last_name>
        <phone>34255</phone>
        <email>drserpilsahin@gmail.com</email>
      </contact>
      <contact_backup>
        <last_name>BATUHAN BURHAN, MD</last_name>
        <email>fenerlibatuhan@gmail.com</email>
      </contact_backup>
      <investigator>
        <last_name>SERPİL SEHİRLİOGLU, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>BATUHAN BURHAN, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Zhang Y, Wang YP, Wang HT, Xu YC, Lv HM, Yu Y, Wang P, Pei XD, Zhao JW, Nan ZH, Yang JJ. Ultrasound-guided quadratus lumborum block provided more effective analgesia for children undergoing lower abdominal laparoscopic surgery: a randomized clinical trial. Surg Endosc. 2022 Dec;36(12):9046-9053. doi: 10.1007/s00464-022-09370-z. Epub 2022 Jun 28.</citation>
      <PMID>35764836</PMID>
    </reference>
    <reference>
      <citation>Aygun H, Kavrut Ozturk N, Pamukcu AS, Inal A, Kiziloglu I, Thomas DT, Tulgar S, Nart A. Comparison of ultrasound guided Erector Spinae Plane Block and quadratus lumborum block for postoperative analgesia in laparoscopic cholecystectomy patients; a prospective randomized study. J Clin Anesth. 2020 Jun;62:109696. doi: 10.1016/j.jclinane.2019.109696. Epub 2019 Dec 18.</citation>
      <PMID>31862217</PMID>
    </reference>
    <reference>
      <citation>Herman JA, Urits I, Kaye AD, Urman RD, Viswanath O. Erector Spinae Plane Block (ESPB) or Quadratus Lumborum Block (QLB-II) for laparoscopic cholecystectomy: Impact on postoperative analgesia. J Clin Anesth. 2020 Nov;66:109958. doi: 10.1016/j.jclinane.2020.109958. Epub 2020 Jun 17. No abstract available.</citation>
      <PMID>32563073</PMID>
    </reference>
    <reference>
      <citation>Arafa SK, Elsayed AA, Hagras AM, Shama AAA. Pediatric Postoperative Pain Control With Quadratus Lumborum Block and Dexamethasone in Two Routes With Bupivacaine: A Prospective Randomized Controlled Clinical Trial. Pain Physician. 2022 Oct;25(7):E987-E998.</citation>
      <PMID>36288584</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>postoperative pain</keyword>
    <keyword>laparoscopic cholecystectomy</keyword>
    <keyword>quadratus lumborum block</keyword>
    <keyword>abdominal wall blocks</keyword>
    <keyword>adjuvant</keyword>
    <keyword>dexamethasone</keyword>
    <keyword>postoperative analgesia</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pain, Postoperative</mesh_term>
    </condition_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/NCT06028061
  org study id: GaziosmanpasaTREHBB
  nct id: NCT06028061
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  İn recent years abdominal wall blocks are widely used for to reduce intraoperative anesthetic
        recuirements and postoperative analgesia.Quadratus lumborum blocks are one of the abdominal
        wall blocks to used at laparoscopic cholecystectomy.Conventionally adjuvants used to improve
        and prolonged the effect of periferic nerve, spinal and abdominal blocks.İn this study
        investigators will evaluate the effectiveness of adjuvants at quatratus lumborum block at
        patient underwent laparoscopic cholecystectomy.
  Laparoscopic approach in cholecystectomy surgery is frequently preferred because of its
        advantages in systemic complications, morbidity, mortality and hospital stay. Pain is one of
        the important causes of late discharge after surgery. Laparoscopic cholecystectomy surgery
        requires a multimodal analgesia approach because of its multiple pain components.Regional
        analgesia techniques are effective in reducing the side effects such as intraoperative opioid
        use, postoperative pain and nausea and vomiting. Quadratus lumborum III block is a regional
        technique performed for multimodal analgesia.Adjuvants are known to improve the analgesic
        efficacy and prolonge the effect of the periferic and central nerve blocks.The aim of this
        study is to determine the effectiveness of adding adjuvant at quadratus lumborum block for
        patients who underwent laparoscopic cholecystectomy.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Double (Participant, Care Provider)
  measure: Total amount of opioid requirements
  time frame: within 24 hours after the surgery
  description: The total tramadol use of the patients in 24 hours will be recorded.
  measure: rescue analgesia
  time frame: within 24 hours after the surgery
  description: The rescue analgesia requirement and time of the need of the rescue analgesia requirement
  measure: intraoperative remifentanil consumption
  time frame: during operation procedure]
  description: The total remifentanil use to be used in the maintenance of 0.05-0.2 mcg/kg remifentanil will be recorded by titration according to the hemodynamic data of the intraoperative patients.
  measure: Visual Analogue Scale values
  time frame: at 1st, 4th,8th 12th and 24th hours after the surgery]
  description: Visual Analogue Scale is a scale of 0-10 cm in length, expressed by non-standard verbal descriptors (no pain-unbearable pain..) indicating the limits of pain intensity on both sides, horizontally or vertically.
  measure: side effects such as nausea, vomiting and shoulder pain
  time frame: within 24 hours after the surgery
  description: The incidence of postoperative side effects such as nausea, vomiting and shoulder pain will be evaluated.
  arm group label: Quadratus lumborum block
  arm group type: Active Comparator
  description: Patients are placed in the lateral decubitus position. The area where the block will be applied is disinfected with povidine iodine. A convex ultrasound probe is placed on the midaxillary line above the iliac crest. By visualizing the transverse process adjacent to the psoas major and quadratus lumborum muscles, using the in-plane technique, using a 22 gauge 80 mm peripheral block needle after negative aspiration into the anterior layer of the thoracolumbar fascia anterior to the quadratus lumborum muscle muscle, 0.5-1 ml of serum After observing hydrodissection with physiological, 20 ml of 0.25% bupivacaine is injected. The same is done to the opposite side.
  arm group label: Quadratus Lumborum Block with adjuvant
  arm group type: Active Comparator
  description: Patients are placed in the lateral decubitus position. The area where the block will be applied is disinfected with povidine iodine. A convex ultrasound probe is placed on the midaxillary line above the iliac crest. By visualizing the transverse process adjacent to the psoas major and quadratus lumborum muscles, using the in-plane technique, using a 22 gauge 80 mm peripheral block needle after negative aspiration into the anterior layer of the thoracolumbar fascia anterior to the quadratus lumborum muscle muscle, 0.5-1 ml of serum After observing hydrodissection with physiological, 20 ml of 0.25% bupivacaine and 4mg dexamethasone is injected. The same is done to the opposite side.
  intervention type: Procedure
  intervention name: Quadratus Lumborum Block III
  description: Patients are placed in the lateral decubitus position. The area where the block will be applied is disinfected with povidine iodine. A convex ultrasound probe is placed on the midaxillary line above the iliac crest. By visualizing the transverse process adjacent to the psoas major and quadratus lumborum muscles, using the in-plane technique, using a 22 gauge 80 mm peripheral block needle after negative aspiration into the anterior layer of the thoracolumbar fascia anterior to the quadratus lumborum muscle muscle, 0.5-1 ml of serum After observing hydrodissection with physiological, 20 ml of 0.25% bupivacaine is injected. The same is done to the opposite side.
  arm group label: Quadratus lumborum block
  intervention type: Procedure
  intervention name: Quadratus lumborum block III with Adjuvant
  description: Patients are placed in the lateral decubitus position. The area where the block will be applied is disinfected with povidine iodine. A convex ultrasound probe is placed on the midaxillary line above the iliac crest. By visualizing the transverse process adjacent to the psoas major and quadratus lumborum muscles, using the in-plane technique, using a 22 gauge 80 mm peripheral block needle after negative aspiration into the anterior layer of the thoracolumbar fascia anterior to the quadratus lumborum muscle muscle, 0.5-1 ml of serum After observing hydrodissection with physiological, 20 ml of 0.25% bupivacaine and 4mg dexamethasone is injected. The same is done to the opposite side.
  arm group label: Quadratus Lumborum Block with adjuvant
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: SERPİL SEHİRLİOGLU, MD
  role: Principal Investigator
  affiliation: Gaziosmanpasa Research and Education Hospital
  last name: BATUHAN BURHAN, MD
  role: Principal Investigator
  affiliation: Gaziosmanpasa Research and Education Hospital
  last name: DONDU GENC MORALAR, MD
  role: Study Director
  affiliation: Gaziosmanpasa Research and Education Hospital
  last name: Serpil SEHİRLİOGLU, MD
  phone: +905054431852
  email: drserpilsahin@gmail.com
  last name: Batuhan BURHAN, MD
  phone: +905398740609
  email: fenerlibatuhan@gmail.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  country: Turkey
  citation: Zhang Y, Wang YP, Wang HT, Xu YC, Lv HM, Yu Y, Wang P, Pei XD, Zhao JW, Nan ZH, Yang JJ. Ultrasound-guided quadratus lumborum block provided more effective analgesia for children undergoing lower abdominal laparoscopic surgery: a randomized clinical trial. Surg Endosc. 2022 Dec;36(12):9046-9053. doi: 10.1007/s00464-022-09370-z. Epub 2022 Jun 28.
  PMID: 35764836
  citation: Aygun H, Kavrut Ozturk N, Pamukcu AS, Inal A, Kiziloglu I, Thomas DT, Tulgar S, Nart A. Comparison of ultrasound guided Erector Spinae Plane Block and quadratus lumborum block for postoperative analgesia in laparoscopic cholecystectomy patients; a prospective randomized study. J Clin Anesth. 2020 Jun;62:109696. doi: 10.1016/j.jclinane.2019.109696. Epub 2019 Dec 18.
  PMID: 31862217
  citation: Herman JA, Urits I, Kaye AD, Urman RD, Viswanath O. Erector Spinae Plane Block (ESPB) or Quadratus Lumborum Block (QLB-II) for laparoscopic cholecystectomy: Impact on postoperative analgesia. J Clin Anesth. 2020 Nov;66:109958. doi: 10.1016/j.jclinane.2020.109958. Epub 2020 Jun 17. No abstract available.
  PMID: 32563073
  citation: Arafa SK, Elsayed AA, Hagras AM, Shama AAA. Pediatric Postoperative Pain Control With Quadratus Lumborum Block and Dexamethasone in Two Routes With Bupivacaine: A Prospective Randomized Controlled Clinical Trial. Pain Physician. 2022 Oct;25(7):E987-E998.
  PMID: 36288584
  responsible party type: Sponsor
  mesh term: Pain, Postoperative
  sharing ipd: No