<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/NCT04496193</url>
  </required_header>
  <id_info>
    <org_study_id>KMUHIRB-F(I)-20200099</org_study_id>
    <nct_id>NCT04496193</nct_id>
  </id_info>
  <brief_title>The Effects of Adding Dexamethasone in the Quadratus Lumborum Block</brief_title>
  <official_title>Comparing the Effects of Adding Dexamethasone in 0.25% Ropivacaine With 0.5% Ropivacaine Alone in the Quadratus Lumborum Block</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kaohsiung Medical University Chung-Ho Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kaohsiung Medical University Chung-Ho Memorial Hospital</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>
      The quadratus lumborum block is widely used in abdominal surgery for post-operative&#xD;
      analgesia. It is now also used for pain relief after hip surgery. Under the traditional&#xD;
      blocking method, a high concentration of long-acting local anesthetic is used in order to&#xD;
      achieve a long-term blocking effect. However, this is also likely to cause the patient's&#xD;
      quadriceps weakness during the block period, increasing the risk of the patient falling&#xD;
      during rehabilitation. It also increases systemic local anesthetic poisoning and may even&#xD;
      trigger the risk of serious side effects such as cardiac arrest. Ropivacaine is a novel&#xD;
      long-acting topical amine anesthetics that lasts long and has anesthetic and analgesic&#xD;
      effects. Its pharmacological characteristics are low cardiotoxicity, sensory block and motor&#xD;
      block separation at low concentrations more obvious, and with the external peripheral&#xD;
      vasoconstriction. Therefore, the drug is especially suitable for postoperative analgesia.&#xD;
&#xD;
      Dexamethasone is a synthetic corticosteroid for the treatment of a wide range of symptoms&#xD;
      including rheumatic diseases, certain skin diseases, severe allergies, asthma, chronic&#xD;
      obstructive pulmonary disease, cerebral edema, and may also be combined with antibiotics for&#xD;
      tuberculosis patients. It is becoming more common to use steroids as an adjuvant to local&#xD;
      anesthetics in peripheral nerve block. Steroids have neurological blockade effects by&#xD;
      blocking the nociceptive transmission of pith-type C-fibers and inhibiting the release of&#xD;
      ectopic neurons. Dexamethasone, as a local anesthetic adjuvant in peripheral nerve block, has&#xD;
      also been widely studied recently.&#xD;
&#xD;
      In order to reduce the incidence of long-acting topical anesthetics from the nerve block in&#xD;
      the quadratus lumborum block, reducing the local anesthetic concentration is a feasible&#xD;
      method. However, this will also result in a shorter time to neurological block. The&#xD;
      investigators hypothesized that the addition of Dexamethasone 5 mg to low concentrations&#xD;
      (0.25%) of Ropivacaine would prolong postoperative analgesia. Therefore, the purpose of this&#xD;
      study was to compare the postoperative analgesia and the side effects of postoperative&#xD;
      quadratus lumborum block with the addition of Dexamethasone 4mg to Ropivacaine (0.25%) in low&#xD;
      concentrations and Ropivacaine (0.5%) alone.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Test drug:&#xD;
&#xD;
        1. Name: Dexamethasone sod. Phosphate&#xD;
&#xD;
        2. Dosage form: 5 milligram (mg)/1 milliliter (mL)/Amp&#xD;
&#xD;
        3. Dose(s): 4mg&#xD;
&#xD;
        4. Dosing schedule: Dexamethasone 4mg adds into 0.25% Ropivacaine 20 mL&#xD;
&#xD;
        5. Mechanism of action: Synthesis of adrenocortical hormones, has a strong&#xD;
           anti-inflammatory effect, can prolong the effect of local anesthetic drugs&#xD;
&#xD;
        6. Pharmacological category: HS051 Glucocorticoids&#xD;
&#xD;
      Study design:&#xD;
&#xD;
      1. ☑ Control: ☑ placebo（N/S 0.8 mL + 0.25% Ropivacaine 20 mL）&#xD;
&#xD;
        -  active (Dexamethasone 4mg＋0.25% Ropivacaine 20 mL)&#xD;
&#xD;
        -  others（N/S 0.8 mL + 0. 5% Ropivacaine 20 mL） □ Uncontrolled 2. Blinding: □ open-label □&#xD;
           single blind ☑ double blind □ others 3. Randomized: ☑ yes □ no 4. ☑ Parallel □&#xD;
           cross-over □ others 5. Duration of study：from Institutional Review Board (IRB) approval&#xD;
           ~to 12, 31, 2022 ,total 24 months Duration of Enrollment : from IRB approval ~to 12, 31,&#xD;
           2022 ,total 24 months Duration of treatment：from IRB approval ~to 12, 31, 2022 ,total 24&#xD;
           months Duration of follow-up: from IRB approval ~to 12, 31, 2022 ,total 24 months&#xD;
&#xD;
             -  Multi-national □multi-center(Taiwan) ☑single center(Taiwan) 6. Number of subjects:&#xD;
                90 7. Is there any of the followings included Data Safety and Monitoring Board&#xD;
                (DSMB)&#xD;
&#xD;
             -  yes ☑ no&#xD;
&#xD;
      Assessment criteria:&#xD;
&#xD;
      1. Efficacy:&#xD;
&#xD;
        1. The intensity of pain was assessed using a 0 to 10 Numerical Rating Scale (NRS) to&#xD;
           quantify their degree of pain; where 0 means no pain and 10 the worst pain imaginable.&#xD;
&#xD;
        2. The analgesic activity was assessed using standard measures during the 48-hour treatment&#xD;
           period: baseline pain intensity, time to rescue medication, and overall patient&#xD;
           evaluation of study medication.&#xD;
&#xD;
      2. Safety:&#xD;
&#xD;
        1. Record the hemodynamic parameters during the 60-minute observation period in the&#xD;
           anesthesia recovery room.&#xD;
&#xD;
        2. The severity of postoperative side effects (nausea, vomiting, pruritus) was quantified&#xD;
           using different scales. Other side effects, including dizziness and drowsiness, are also&#xD;
           recorded.&#xD;
&#xD;
        3. Motor block is assessed using Modified Bromage Scale.&#xD;
&#xD;
      3. Pharmacokinetics: None&#xD;
&#xD;
      4. Quality of life:&#xD;
&#xD;
        1. analgesic activity and duration of action&#xD;
&#xD;
        2. patient satisfaction&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 31, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</primary_completion_date>
  <phase>Phase 4</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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the post-operative analgesic effect of quadratus lumborum block</measure>
    <time_frame>Within 48 hours after surgery</time_frame>
    <description>The pain will be assessed using a 0 to 10 Numerical Rating Scale (NRS)&#xD;
In an hour in the recovery room, the pain will be evaluated every 15 minutes.&#xD;
Then the pain will be assessed at the 3rd, 6th, 12th, 24th, 36th, and 48th hours after surgery.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Analgesia</condition>
  <condition>Motor Activity</condition>
  <arm_group>
    <arm_group_label>Group lower dose ropivacaine with dexamethasone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Quadratus lumborum block was administered with 0.25% Ropivacaine 20 ml + dexamethasone 0.8 ml (4mg) at the end of surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group higher dose ropivacaine with N/S</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Quadratus lumborum block was administered with 0.5% Ropivacaine 20 ml + N/S 0.8 ml at the end of surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group lower dose ropivacaine with N/S</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Quadratus lumborum block was administered with 0.25% Ropivacaine 20 ml + N/S 0.8 ml at the end of surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Quadratus Lumborum block</intervention_name>
    <description>Quadratus Lumborum block is a type of plane block where local anesthetic is injected adjacent to the quadratus lumborum muscle with the goal of anesthetizing the thoracolumbar nerves.</description>
    <arm_group_label>Group higher dose ropivacaine with N/S</arm_group_label>
    <arm_group_label>Group lower dose ropivacaine with N/S</arm_group_label>
    <arm_group_label>Group lower dose ropivacaine with dexamethasone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) classification: I ~ III&#xD;
&#xD;
          -  Patients who received quadratus lumborum block for post-hip surgery analgesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lumbar plexus degeneration,&#xD;
&#xD;
          -  Coagulation abnormalities with international normalized ratio (INR) &gt; 1.5&#xD;
&#xD;
          -  Obvious heart, lung, liver or kidney disease&#xD;
&#xD;
          -  Body mass index less than 18.5 or greater than 35&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Regular use of steroids or opiates Opioids&#xD;
&#xD;
          -  Chronic medication or alcohol abuse&#xD;
&#xD;
          -  Previous allergies or adverse reactions to opiates, dexamethasone, or ropivacaine&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hung-Te Hsu, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Anesthesiology, Kaohsiung Medical University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hung-Te Hsu, MD, PhD</last_name>
    <phone>+88673121101</phone>
    <phone_ext>7033</phone_ext>
    <email>hdhsu1228@hotmail.com</email>
  </overall_contact>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>July 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>August 2, 2020</last_update_submitted>
  <last_update_submitted_qc>August 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT04496193
org study id: KMUHIRB-F(I)-20200099
nct id: NCT04496193
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The quadratus lumborum block is widely used in abdominal surgery for post-operative
      analgesia. It is now also used for pain relief after hip surgery. Under the traditional
      blocking method, a high concentration of long-acting local anesthetic is used in order to
      achieve a long-term blocking effect. However, this is also likely to cause the patient's
      quadriceps weakness during the block period, increasing the risk of the patient falling
      during rehabilitation. It also increases systemic local anesthetic poisoning and may even
      trigger the risk of serious side effects such as cardiac arrest. Ropivacaine is a novel
      long-acting topical amine anesthetics that lasts long and has anesthetic and analgesic
      effects. Its pharmacological characteristics are low cardiotoxicity, sensory block and motor
      block separation at low concentrations more obvious, and with the external peripheral
      vasoconstriction. Therefore, the drug is especially suitable for postoperative analgesia.

      Dexamethasone is a synthetic corticosteroid for the treatment of a wide range of symptoms
      including rheumatic diseases, certain skin diseases, severe allergies, asthma, chronic
      obstructive pulmonary disease, cerebral edema, and may also be combined with antibiotics for
      tuberculosis patients. It is becoming more common to use steroids as an adjuvant to local
      anesthetics in peripheral nerve block. Steroids have neurological blockade effects by
      blocking the nociceptive transmission of pith-type C-fibers and inhibiting the release of
      ectopic neurons. Dexamethasone, as a local anesthetic adjuvant in peripheral nerve block, has
      also been widely studied recently.

      In order to reduce the incidence of long-acting topical anesthetics from the nerve block in
      the quadratus lumborum block, reducing the local anesthetic concentration is a feasible
      method. However, this will also result in a shorter time to neurological block. The
      investigators hypothesized that the addition of Dexamethasone 5 mg to low concentrations
      (0.25%) of Ropivacaine would prolong postoperative analgesia. Therefore, the purpose of this
      study was to compare the postoperative analgesia and the side effects of postoperative
      quadratus lumborum block with the addition of Dexamethasone 4mg to Ropivacaine (0.25%) in low
      concentrations and Ropivacaine (0.5%) alone.
Test drug:

        1. Name: Dexamethasone sod. Phosphate

        2. Dosage form: 5 milligram (mg)/1 milliliter (mL)/Amp

        3. Dose(s): 4mg

        4. Dosing schedule: Dexamethasone 4mg adds into 0.25% Ropivacaine 20 mL

        5. Mechanism of action: Synthesis of adrenocortical hormones, has a strong
           anti-inflammatory effect, can prolong the effect of local anesthetic drugs

        6. Pharmacological category: HS051 Glucocorticoids

      Study design:

      1. ☑ Control: ☑ placebo（N/S 0.8 mL + 0.25% Ropivacaine 20 mL）

        -  active (Dexamethasone 4mg＋0.25% Ropivacaine 20 mL)

        -  others（N/S 0.8 mL + 0. 5% Ropivacaine 20 mL） □ Uncontrolled 2. Blinding: □ open-label □
           single blind ☑ double blind □ others 3. Randomized: ☑ yes □ no 4. ☑ Parallel □
           cross-over □ others 5. Duration of study：from Institutional Review Board (IRB) approval
           ~to 12, 31, 2022 ,total 24 months Duration of Enrollment : from IRB approval ~to 12, 31,
           2022 ,total 24 months Duration of treatment：from IRB approval ~to 12, 31, 2022 ,total 24
           months Duration of follow-up: from IRB approval ~to 12, 31, 2022 ,total 24 months

             -  Multi-national □multi-center(Taiwan) ☑single center(Taiwan) 6. Number of subjects:
                90 7. Is there any of the followings included Data Safety and Monitoring Board
                (DSMB)

             -  yes ☑ no

      Assessment criteria:

      1. Efficacy:

        1. The intensity of pain was assessed using a 0 to 10 Numerical Rating Scale (NRS) to
           quantify their degree of pain; where 0 means no pain and 10 the worst pain imaginable.

        2. The analgesic activity was assessed using standard measures during the 48-hour treatment
           period: baseline pain intensity, time to rescue medication, and overall patient
           evaluation of study medication.

      2. Safety:

        1. Record the hemodynamic parameters during the 60-minute observation period in the
           anesthesia recovery room.

        2. The severity of postoperative side effects (nausea, vomiting, pruritus) was quantified
           using different scales. Other side effects, including dizziness and drowsiness, are also
           recorded.

        3. Motor block is assessed using Modified Bromage Scale.

      3. Pharmacokinetics: None

      4. Quality of life:

        1. analgesic activity and duration of action

        2. patient satisfaction
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: the post-operative analgesic effect of quadratus lumborum block
time frame: Within 48 hours after surgery
description: The pain will be assessed using a 0 to 10 Numerical Rating Scale (NRS)
In an hour in the recovery room, the pain will be evaluated every 15 minutes.
Then the pain will be assessed at the 3rd, 6th, 12th, 24th, 36th, and 48th hours after surgery.
arm group label: Group lower dose ropivacaine with dexamethasone
arm group type: Experimental
description: Quadratus lumborum block was administered with 0.25% Ropivacaine 20 ml + dexamethasone 0.8 ml (4mg) at the end of surgery
arm group label: Group higher dose ropivacaine with N/S
arm group type: Active Comparator
description: Quadratus lumborum block was administered with 0.5% Ropivacaine 20 ml + N/S 0.8 ml at the end of surgery
arm group label: Group lower dose ropivacaine with N/S
arm group type: Placebo Comparator
description: Quadratus lumborum block was administered with 0.25% Ropivacaine 20 ml + N/S 0.8 ml at the end of surgery
intervention type: Procedure
intervention name: Quadratus Lumborum block
description: Quadratus Lumborum block is a type of plane block where local anesthetic is injected adjacent to the quadratus lumborum muscle with the goal of anesthetizing the thoracolumbar nerves.
arm group label: Group higher dose ropivacaine with N/S
arm group label: Group lower dose ropivacaine with N/S
arm group label: Group lower dose ropivacaine with dexamethasone
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: No
last name: Hung-Te Hsu, MD, PhD
role: Principal Investigator
affiliation: Department of Anesthesiology, Kaohsiung Medical University Hospital
last name: Hung-Te Hsu, MD, PhD
phone: +88673121101
phone ext: 7033
email: hdhsu1228@hotmail.com
responsible party type: Sponsor