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/NCT05964985</url>
    </required_header>
    <id_info>
      <org_study_id>GWang023</org_study_id>
      <nct_id>NCT05964985</nct_id>
    </id_info>
    <brief_title>Effect of Quadratus Lumborum Block With Compound Lidocaine and Esketamine on Pain After Colorectal Surgery</brief_title>
    <official_title>Effect of Ultrasound-guided Quadratus Lumborum Block With Compound Lidocaine and Esketamine on Postoperative Pain in Patients Undergoing Colorectal Surgery: a Randomized Double-blind Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tianjin Medical University General Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tianjin Medical University General 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>
        Purpose:&#xD;
  &#xD;
        To explore effects of ultrasound-guided quadratus lumborum block with compound lidocaine and&#xD;
        esketamine on postoperative pain after colorectal surgery.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Poor post-surgical pain control is a leading factor that hinders the physicalrehabilitation,&#xD;
        and causes acute cognitive impairment and chronic painsyndrome. Recently, the multimodal&#xD;
        analgesia strategies to minimise opioidrelated side effects are highly desirable in open&#xD;
        surgical procedures. Quadratus lumborum block is a novel technique. Although ropivacaine is&#xD;
        most commonly used forthis technique, the analgesic duration remains not dissatisfied.&#xD;
        Compared with ropivacaine, compound lidocaine injection has a better and longer analgesic&#xD;
        activity since it contains menthol and ethanol with appropriate concentrations. However,&#xD;
        whether compound lidocaine injection is efficiency in the quadratus lumborum block for&#xD;
        abdominal surgery lacks investigations. Herein, we will evaluate the efficacy of&#xD;
        ultrasound-guided quadratus lumborum block (USG-QLB) with compound lidocaine injection and&#xD;
        esketamine for postoperative analgesia in patients undergoing colorectal surgery.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 6, 2023</start_date>
    <completion_date type="Anticipated">February 15, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 15, 2024</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>Prevention</primary_purpose>
      <masking>Double (Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Postoperative opioid consumption</measure>
      <time_frame>72 hours after surgery</time_frame>
      <description>Each patient was administered analgesics using a PCA (Patient-controlled analgesia) pump containing opioid in normal saline after leaving PACU (Postanesthesia care unit). Opioid cumulative consumption is recorded for 72 hours postoperatively.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Pain Score (NRS)</measure>
      <time_frame>72 hours after surgery</time_frame>
      <description>The pain score at rest or after movement was evaluated by pain 11-point numerical rating scale (NRS): 0 = no pain, 10= greatest imaginable pain.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time of First Postoperative Analgesic Requirement</measure>
      <time_frame>1 hour after surgery</time_frame>
      <description>First postoperative pain (NRS≥5) is initially controlled by titration of opioid.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total Dose of First Postoperative Analgesic Requirement</measure>
      <time_frame>1 hour after surgery</time_frame>
      <description>First postoperative pain (NRS≥5) is initially controlled by titration of opioid.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The incidence of Side Effects</measure>
      <time_frame>72 hours after surgery</time_frame>
      <description>The number of patients with side effects including nausea, vomiting, dizziness, headache, shivering, and pruritus is recorded for 72 hours postoperatively.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Apfel score</measure>
      <time_frame>The 1 day before the surgery</time_frame>
      <description>The Apfel score was recorded for evaluating risk for developing postoperative nausea and vomiting (PONV).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean time until passage of flatus</measure>
      <time_frame>96 hours after surgery</time_frame>
      <description>Gastrointestinal motility was evaluated by recording mean time until passage of flatus</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Diffusion area of local anesthetics after quadratus lumborum block</measure>
      <time_frame>30 minutes after quadratus lumborum block</time_frame>
      <description>Diffusion area of local anesthetics after quadratus lumborum block was calculated under ultrasound assistance.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Normalized Area of Hyperalgesia Around the Incision</measure>
      <time_frame>72 hours after surgery</time_frame>
      <description>The skin around the incision is stimulated in steps of 5 mm at intervals of 1 s starting outside of the hyperalgesic area in the direction of the incision. The distance from the incision to the first point where a 'painful', 'sore' or 'sharper' feeling occurred is measured and noted. This measurement is repeated at predefined radial lines around the incision. To eliminate the variable length of incision, this length is subtracted from the longer diameter leaving four radial distances from the end and from the middle of the incision. The normalized area of hyperalgesia is calculated by summing up the areas of the remaining four triangles measured by and Von Frey filament.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The level of cytokines in blood By ELISA kits</measure>
      <time_frame>72 hours after surgery</time_frame>
      <description>Blood is collected to measure the level of cytokines (such as IL-18, IL-17, IL-23 ) using ELISA kits.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The level of chemokines in blood By ELISA kits</measure>
      <time_frame>72 hours after surgery</time_frame>
      <description>Blood is collected to measure the level of chemokines (such as CXCL1, CCL7, CCL2) using ELISA kits.</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">160</enrollment>
    <condition>Postoperative Pain</condition>
    <arm_group>
      <arm_group_label>Normal saline in quadratus lumborum block</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>After the induction of anesthesia, normal saline is used for bilateral quadratus lumborum block in a volume of 20 mL of each side.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Ropivacaine in quadratus lumborum block</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>After the induction of anesthesia, 0.375% ropivacaine is used for bilateral quadratus lumborum block in a volume of 20 mL of each side.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Compound lidocaine in quadratus lumborum block</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>After the induction of anesthesia, 0.6% compound lidocaine is used for bilateral quadratus lumborum block in a volume of 20 mL of each side.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Compound lidocaine and esketamine in quadratus lumborum block</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>After the induction of anesthesia, 0.6% compound lidocaine and 0.4 mg/kg esketamine are used for bilateral quadratus lumborum block in a volume of 20 mL of each side.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Normal saline</intervention_name>
      <description>After the induction of anesthesia, normal saline is used for bilateral quadratus lumborum block in a volume of 20 mL of each side</description>
      <arm_group_label>Normal saline in quadratus lumborum block</arm_group_label>
      <other_name>0. 9% Sodium Chloride Injection</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Ropivacaine</intervention_name>
      <description>After the induction of anesthesia, 0.375% ropivacaine is used for bilateral quadratus lumborum block in a volume of 20 mL of each side</description>
      <arm_group_label>Ropivacaine in quadratus lumborum block</arm_group_label>
      <other_name>Ropivacaine Hydrochloride Injection</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Compound lidocaine</intervention_name>
      <description>After the induction of anesthesia, 0.6% compound lidocaine is used for bilateral quadratus lumborum block in a volume of 20 mL of each side</description>
      <arm_group_label>Compound lidocaine and esketamine in quadratus lumborum block</arm_group_label>
      <arm_group_label>Compound lidocaine in quadratus lumborum block</arm_group_label>
      <other_name>Compound Lidocaine Hydrochloride Injection</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Esketamine</intervention_name>
      <description>After the induction of anesthesia, 0.4mg/kg esketamine is used for bilateral quadratus lumborum block</description>
      <arm_group_label>Compound lidocaine and esketamine in quadratus lumborum block</arm_group_label>
      <other_name>Esketamine injection</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Subject is scheduled to undergo colorectal cancer surgery under general anesthesia&#xD;
  &#xD;
            2. Subject's American Society of Anesthesiologists physical status is I-III.&#xD;
  &#xD;
            3. The subject's parent/legally authorized guardian has given written informed consent to&#xD;
               participate&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Subject has a diagnosis of bronchial asthma, coronary heart disease, severe&#xD;
               hypertension, renal failure or liver failure.&#xD;
  &#xD;
            2. Subject has a diagnosis of Insulin dependent diabetes.&#xD;
  &#xD;
            3. Subject is allergy and contraindication to local anesthetics or any components of&#xD;
               local anesthetics.&#xD;
  &#xD;
            4. Subject has a history of chronic pain, a history of alcohol or opioid abuse, pre-&#xD;
               existing therapy with opioids, intake of any analgesic drug within 48 hours before&#xD;
               surgery.&#xD;
  &#xD;
            5. Subject has any contraindication for the use of patient-controlled analgesia (PCA).&#xD;
  &#xD;
            6. Subject is pregnant or breast-feeding.&#xD;
  &#xD;
            7. Subject is obese (body mass index &gt;30kg/m^2).&#xD;
  &#xD;
            8. Subject is incapacity to comprehend pain assessment and cognitive assessment.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Guolin Wang, MD</last_name>
      <role>Study Director</role>
      <affiliation>Tianjin Medical University General Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Guolin Wang, MD</last_name>
      <phone>+86 15822855556</phone>
      <email>wangguolinghad@hotmail.com</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 20, 2023</last_update_submitted>
    <last_update_submitted_qc>July 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Tianjin Medical University General Hospital</investigator_affiliation>
      <investigator_full_name>Guolin Wang</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Compound lidocaine</keyword>
    <keyword>Esketamine</keyword>
    <keyword>Quadratus lumborum block</keyword>
    <keyword>opioid consumption</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pain, Postoperative</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lidocaine</mesh_term>
      <mesh_term>Ropivacaine</mesh_term>
      <mesh_term>Esketamine</mesh_term>
    </intervention_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/NCT05964985
  org study id: GWang023
  nct id: NCT05964985
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Purpose:
  
        To explore effects of ultrasound-guided quadratus lumborum block with compound lidocaine and
        esketamine on postoperative pain after colorectal surgery.
  Poor post-surgical pain control is a leading factor that hinders the physicalrehabilitation,
        and causes acute cognitive impairment and chronic painsyndrome. Recently, the multimodal
        analgesia strategies to minimise opioidrelated side effects are highly desirable in open
        surgical procedures. Quadratus lumborum block is a novel technique. Although ropivacaine is
        most commonly used forthis technique, the analgesic duration remains not dissatisfied.
        Compared with ropivacaine, compound lidocaine injection has a better and longer analgesic
        activity since it contains menthol and ethanol with appropriate concentrations. However,
        whether compound lidocaine injection is efficiency in the quadratus lumborum block for
        abdominal surgery lacks investigations. Herein, we will evaluate the efficacy of
        ultrasound-guided quadratus lumborum block (USG-QLB) with compound lidocaine injection and
        esketamine for postoperative analgesia in patients undergoing colorectal surgery.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Double (Investigator, Outcomes Assessor)
  measure: Postoperative opioid consumption
  time frame: 72 hours after surgery
  description: Each patient was administered analgesics using a PCA (Patient-controlled analgesia) pump containing opioid in normal saline after leaving PACU (Postanesthesia care unit). Opioid cumulative consumption is recorded for 72 hours postoperatively.
  measure: Pain Score (NRS)
  time frame: 72 hours after surgery
  description: The pain score at rest or after movement was evaluated by pain 11-point numerical rating scale (NRS): 0 = no pain, 10= greatest imaginable pain.
  measure: Time of First Postoperative Analgesic Requirement
  time frame: 1 hour after surgery
  description: First postoperative pain (NRS≥5) is initially controlled by titration of opioid.
  measure: Total Dose of First Postoperative Analgesic Requirement
  time frame: 1 hour after surgery
  description: First postoperative pain (NRS≥5) is initially controlled by titration of opioid.
  measure: The incidence of Side Effects
  time frame: 72 hours after surgery
  description: The number of patients with side effects including nausea, vomiting, dizziness, headache, shivering, and pruritus is recorded for 72 hours postoperatively.
  measure: Apfel score
  time frame: The 1 day before the surgery
  description: The Apfel score was recorded for evaluating risk for developing postoperative nausea and vomiting (PONV).
  measure: Mean time until passage of flatus
  time frame: 96 hours after surgery
  description: Gastrointestinal motility was evaluated by recording mean time until passage of flatus
  measure: Diffusion area of local anesthetics after quadratus lumborum block
  time frame: 30 minutes after quadratus lumborum block
  description: Diffusion area of local anesthetics after quadratus lumborum block was calculated under ultrasound assistance.
  measure: Normalized Area of Hyperalgesia Around the Incision
  time frame: 72 hours after surgery
  description: The skin around the incision is stimulated in steps of 5 mm at intervals of 1 s starting outside of the hyperalgesic area in the direction of the incision. The distance from the incision to the first point where a 'painful', 'sore' or 'sharper' feeling occurred is measured and noted. This measurement is repeated at predefined radial lines around the incision. To eliminate the variable length of incision, this length is subtracted from the longer diameter leaving four radial distances from the end and from the middle of the incision. The normalized area of hyperalgesia is calculated by summing up the areas of the remaining four triangles measured by and Von Frey filament.
  measure: The level of cytokines in blood By ELISA kits
  time frame: 72 hours after surgery
  description: Blood is collected to measure the level of cytokines (such as IL-18, IL-17, IL-23 ) using ELISA kits.
  measure: The level of chemokines in blood By ELISA kits
  time frame: 72 hours after surgery
  description: Blood is collected to measure the level of chemokines (such as CXCL1, CCL7, CCL2) using ELISA kits.
  arm group label: Normal saline in quadratus lumborum block
  arm group type: Placebo Comparator
  description: After the induction of anesthesia, normal saline is used for bilateral quadratus lumborum block in a volume of 20 mL of each side.
  arm group label: Ropivacaine in quadratus lumborum block
  arm group type: Active Comparator
  description: After the induction of anesthesia, 0.375% ropivacaine is used for bilateral quadratus lumborum block in a volume of 20 mL of each side.
  arm group label: Compound lidocaine in quadratus lumborum block
  arm group type: Active Comparator
  description: After the induction of anesthesia, 0.6% compound lidocaine is used for bilateral quadratus lumborum block in a volume of 20 mL of each side.
  arm group label: Compound lidocaine and esketamine in quadratus lumborum block
  arm group type: Active Comparator
  description: After the induction of anesthesia, 0.6% compound lidocaine and 0.4 mg/kg esketamine are used for bilateral quadratus lumborum block in a volume of 20 mL of each side.
  intervention type: Drug
  intervention name: Normal saline
  description: After the induction of anesthesia, normal saline is used for bilateral quadratus lumborum block in a volume of 20 mL of each side
  arm group label: Normal saline in quadratus lumborum block
  other name: 0. 9% Sodium Chloride Injection
  intervention type: Drug
  intervention name: Ropivacaine
  description: After the induction of anesthesia, 0.375% ropivacaine is used for bilateral quadratus lumborum block in a volume of 20 mL of each side
  arm group label: Ropivacaine in quadratus lumborum block
  other name: Ropivacaine Hydrochloride Injection
  intervention type: Drug
  intervention name: Compound lidocaine
  description: After the induction of anesthesia, 0.6% compound lidocaine is used for bilateral quadratus lumborum block in a volume of 20 mL of each side
  arm group label: Compound lidocaine and esketamine in quadratus lumborum block
  arm group label: Compound lidocaine in quadratus lumborum block
  other name: Compound Lidocaine Hydrochloride Injection
  intervention type: Drug
  intervention name: Esketamine
  description: After the induction of anesthesia, 0.4mg/kg esketamine is used for bilateral quadratus lumborum block
  arm group label: Compound lidocaine and esketamine in quadratus lumborum block
  other name: Esketamine injection
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Guolin Wang, MD
  role: Study Director
  affiliation: Tianjin Medical University General Hospital
  last name: Guolin Wang, MD
  phone: +86 15822855556
  email: wangguolinghad@hotmail.com
  responsible party type: Principal Investigator
  investigator affiliation: Tianjin Medical University General Hospital
  investigator full name: Guolin Wang
  investigator title: Professor
  mesh term: Pain, Postoperative
  mesh term: Lidocaine
  mesh term: Ropivacaine
  mesh term: Esketamine
  sharing ipd: No