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/NCT06032624</url>
    </required_header>
    <id_info>
      <org_study_id>Soh-Med-22-07-34</org_study_id>
      <nct_id>NCT06032624</nct_id>
    </id_info>
    <brief_title>Ketamine and Dexmedetomidine Comparative Study</brief_title>
    <official_title>Comparative Study Between Ketamine and Dexmedetomidine as Additives to Local Anesthetic in Ultrasound-guided Combined Sciatic and Femoral Nerve Block</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sohag University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sohag 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>
        In this study, the investigators will compare the effect of adding ketamine and&#xD;
        dexmedetomidine to bupivacaine in US-guided combined sciatic and femoral nerve blocks as&#xD;
        regards the onset and duration of the block, postoperative visual analogue scale, and&#xD;
        analgesic consumption.50 patients with American Society of Anesthesiologists (ASA) grade I to&#xD;
        II, 18 to 60 years of age scheduled for below-knee surgeries, Will be included in the study.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The patients will be randomly classified into two groups:&#xD;
  &#xD;
        Ketamine group (group K):40 ml 0.5%bupivacaine and 0.5 mg\kg ketamine, Dexmedetomidine group&#xD;
        (group D) 40 ml 0.5% bupivacaine and 50µg\kg dexmedetomidine.&#xD;
  &#xD;
        Femoral nerve block: The femoral area will be sterilized using povidone-iodine and alcohol&#xD;
        and then drapes will be put on the patient's thigh, with the operator on the right-hand side&#xD;
        for blocks on both sides and vice versa for a left-handed operator. The ultrasound machine&#xD;
        will be placed on the opposite side so that the operator's line of sight, the needle, and the&#xD;
        screen are in a straight line. The femoral area will be scanned behind the midpoint of the&#xD;
        inguinal ligament and the depth of the image will be set at 3-5 cm and a linear high&#xD;
        frequency 8-12MHz) probe will be placed perpendicular to the course of the femoral nerve.,&#xD;
        medial to the lateral sliding movements of the transducer-aided visualization of the&#xD;
        pulsatile femoral artery. Structures that will be visualized: fascia iliac, femoral artery,&#xD;
        immediately below, and lateral is the femoral nerve in a wedge-shaped space. The femoral&#xD;
        nerve typically is hyperechoic and lies in a sulcus in the iliopsoas inferiorly. In-line&#xD;
        insertion of the needle to reach below fascia iliaca and then a volume of 15 ml of&#xD;
        bupivacaine will be injected to perform the block.&#xD;
  &#xD;
        Sciatic nerve block: The patient will be positioned with the side for the block uppermost,&#xD;
        flexed partially at the hip and knee joints. The iliac area will be sterilized using&#xD;
        povidone-iodine and alcohol, and then drapes will be put on the patient's thigh, with the&#xD;
        operator on the right-hand side for blocks on both sides and vice versa for a lefthanded&#xD;
        operator. The ultrasound machine will be placed on the opposite side so that the operator's&#xD;
        line of sight, the needle, and the screen is in a straight line. A curvilinear low-frequency&#xD;
        (3-9 MHz) probe will be used to do a scan of the sub-gluteal region below a line from the&#xD;
        ischial tuberosity and greater trochanter which are seen as two hyperechoic bony prominences;&#xD;
        the gluteus maximus muscle is as the most superficial muscular layer bridging the two osseous&#xD;
        structures; sciatic nerve lies deep into the gluteus maximus muscle and superficial to the&#xD;
        quadratus femoris muscle as an oval or roughly triangular hyperechoic structure. A volume of&#xD;
        25 ml of bupivacaine will be injected to perform the block.&#xD;
  &#xD;
        The onset and duration of sensory loss and motor blockade will be studied. The loss of&#xD;
        pinprick sensation will be checked every 5 minutes till the onset of loss of sensation and&#xD;
        then every 2 hours till the regain of sensation. The motor blockade will be assessed every 5&#xD;
        minutes till the loss of movements and then every 2 hours till the regain of movements.&#xD;
  &#xD;
        The onset of action: Sensory and motor blockade Sensory block: The time interval between full&#xD;
        deposition of local anesthetic solution till loss of pinprick sensation at the site of&#xD;
        surgery.&#xD;
  &#xD;
        Motor block: The time interval between administering the local anesthetic solution to the&#xD;
        loss of movements.&#xD;
  &#xD;
        Duration of blockade:&#xD;
  &#xD;
        Sensory block: Time interval between loss of pinprick sensation to the appearance of pinprick&#xD;
        sensation.&#xD;
  &#xD;
        Motor block: Time interval between loss of movements to the appearance of the movements.&#xD;
  &#xD;
        The basal heart rate (HR); noninvasive arterial systolic blood pressure (SBP) and diastolic&#xD;
        blood pressure (DBP); and peripheral oxygen saturation (SpO2) will be recorded. An 18-gauge&#xD;
        (G) i.v. the cannula will be inserted in the non-operated arm and lactated Ringer's solution&#xD;
        will be started at 5 ml/kg/h.&#xD;
  &#xD;
        HR, SBP, and DBP will also be recorded at 0, 5, 10, 15, 30, 45-, 60-, 90-, and 120-min.&#xD;
        Adverse effects will be considered as hypotension (i.e., 20% decrease relative to baseline),&#xD;
        bradycardia (HR &lt;50 beats/min), nausea, vomiting, and hypoxemia (SpO2 &lt;90%). Any need for&#xD;
        additional medication will be noted intraoperatively. Blood loss will be calculated by the&#xD;
        gravimetric method and will be replaced if more than the allowable blood loss. Pain will be&#xD;
        assessed using a visual analog scale (VRS) (O=no pain 1=mild pain 2=moderate pain 3=severe&#xD;
        pain 4=unbearable pain).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 1, 2023</start_date>
    <completion_date type="Anticipated">July 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">May 1, 2025</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>Health Services Research</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>the onset of the femoral nerve block</measure>
      <time_frame>from the deposition of the local anesthetic till the loss of pinprick sensation</time_frame>
      <description>The time interval between the deposition of the local anesthetic and the loss of pinprick sensation at the site of surgery.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Post Operative Pain</condition>
    <arm_group>
      <arm_group_label>Ketamine group (group K)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Ketamine group (group K):40 ml 0.5%bupivacaine and 0.5 mg\kg ketamine.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Dexmedetomidine group (group D)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Dexmedetomidine group (group D) 40 ml 0.5% bupivacaine and 50µg\kg dexmedetomidine.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>combined ultra-sound guided femoral and sciatic nerve block.</intervention_name>
      <description>Femoral nerve block, The femoral area will be scanned behind the midpoint of the inguinal ligament and the depth of the image will be set at 3-5 cm, and a linear high frequency 8-12MHz) probe will be placed perpendicular to the course of the femoral nerve., the volume of 15 ml of bupivacaine will be injected to perform the block. Sciatic nerve block, A curvilinear low-frequency (3-9 MHz) probe will be used to do a scan of the sub-gluteal region below a line from the ischial tuberosity and greater trochanter which are seen as two hyperechoic bony prominences,A volume of 25 ml of bupivacaine will be injected to perform the block.</description>
      <arm_group_label>Dexmedetomidine group (group D)</arm_group_label>
      <arm_group_label>Ketamine group (group K)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          50 patients with American Society of Anesthesiologists (ASA) grade I to II, 18 to 60 years&#xD;
          of age scheduled for below-knee surgeries, Will be included in the study.&#xD;
  &#xD;
          -&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patient refusal.&#xD;
  &#xD;
            -  Patient with significant neurological, psychiatric or neuromuscular disease.&#xD;
  &#xD;
            -  Alcoholism.&#xD;
  &#xD;
            -  Drug abuse.&#xD;
  &#xD;
            -  Pregnancy or lactating women.&#xD;
  &#xD;
            -  Suspected Coagulopathy.&#xD;
  &#xD;
            -  Morbid obesity.&#xD;
  &#xD;
            -  Known allergy to study medications.&#xD;
  &#xD;
            -  Septicaemia and local infection at the block site.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Mohammed Mahmoud, MD</last_name>
      <phone>00201091328413</phone>
      <email>mohamedmahmoud@med.sohag.edu.eg</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>November 9, 2022</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sohag University</investigator_affiliation>
      <investigator_full_name>Mohammed Ahmed Mahmoud</investigator_full_name>
      <investigator_title>Lecturer</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pain, Postoperative</mesh_term>
    </condition_browse>
    <!-- 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/NCT06032624
  org study id: Soh-Med-22-07-34
  nct id: NCT06032624
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  In this study, the investigators will compare the effect of adding ketamine and
        dexmedetomidine to bupivacaine in US-guided combined sciatic and femoral nerve blocks as
        regards the onset and duration of the block, postoperative visual analogue scale, and
        analgesic consumption.50 patients with American Society of Anesthesiologists (ASA) grade I to
        II, 18 to 60 years of age scheduled for below-knee surgeries, Will be included in the study.
  The patients will be randomly classified into two groups:
  
        Ketamine group (group K):40 ml 0.5%bupivacaine and 0.5 mg\kg ketamine, Dexmedetomidine group
        (group D) 40 ml 0.5% bupivacaine and 50µg\kg dexmedetomidine.
  
        Femoral nerve block: The femoral area will be sterilized using povidone-iodine and alcohol
        and then drapes will be put on the patient's thigh, with the operator on the right-hand side
        for blocks on both sides and vice versa for a left-handed operator. The ultrasound machine
        will be placed on the opposite side so that the operator's line of sight, the needle, and the
        screen are in a straight line. The femoral area will be scanned behind the midpoint of the
        inguinal ligament and the depth of the image will be set at 3-5 cm and a linear high
        frequency 8-12MHz) probe will be placed perpendicular to the course of the femoral nerve.,
        medial to the lateral sliding movements of the transducer-aided visualization of the
        pulsatile femoral artery. Structures that will be visualized: fascia iliac, femoral artery,
        immediately below, and lateral is the femoral nerve in a wedge-shaped space. The femoral
        nerve typically is hyperechoic and lies in a sulcus in the iliopsoas inferiorly. In-line
        insertion of the needle to reach below fascia iliaca and then a volume of 15 ml of
        bupivacaine will be injected to perform the block.
  
        Sciatic nerve block: The patient will be positioned with the side for the block uppermost,
        flexed partially at the hip and knee joints. The iliac area will be sterilized using
        povidone-iodine and alcohol, and then drapes will be put on the patient's thigh, with the
        operator on the right-hand side for blocks on both sides and vice versa for a lefthanded
        operator. The ultrasound machine will be placed on the opposite side so that the operator's
        line of sight, the needle, and the screen is in a straight line. A curvilinear low-frequency
        (3-9 MHz) probe will be used to do a scan of the sub-gluteal region below a line from the
        ischial tuberosity and greater trochanter which are seen as two hyperechoic bony prominences;
        the gluteus maximus muscle is as the most superficial muscular layer bridging the two osseous
        structures; sciatic nerve lies deep into the gluteus maximus muscle and superficial to the
        quadratus femoris muscle as an oval or roughly triangular hyperechoic structure. A volume of
        25 ml of bupivacaine will be injected to perform the block.
  
        The onset and duration of sensory loss and motor blockade will be studied. The loss of
        pinprick sensation will be checked every 5 minutes till the onset of loss of sensation and
        then every 2 hours till the regain of sensation. The motor blockade will be assessed every 5
        minutes till the loss of movements and then every 2 hours till the regain of movements.
  
        The onset of action: Sensory and motor blockade Sensory block: The time interval between full
        deposition of local anesthetic solution till loss of pinprick sensation at the site of
        surgery.
  
        Motor block: The time interval between administering the local anesthetic solution to the
        loss of movements.
  
        Duration of blockade:
  
        Sensory block: Time interval between loss of pinprick sensation to the appearance of pinprick
        sensation.
  
        Motor block: Time interval between loss of movements to the appearance of the movements.
  
        The basal heart rate (HR); noninvasive arterial systolic blood pressure (SBP) and diastolic
        blood pressure (DBP); and peripheral oxygen saturation (SpO2) will be recorded. An 18-gauge
        (G) i.v. the cannula will be inserted in the non-operated arm and lactated Ringer's solution
        will be started at 5 ml/kg/h.
  
        HR, SBP, and DBP will also be recorded at 0, 5, 10, 15, 30, 45-, 60-, 90-, and 120-min.
        Adverse effects will be considered as hypotension (i.e., 20% decrease relative to baseline),
        bradycardia (HR <50 beats/min), nausea, vomiting, and hypoxemia (SpO2 <90%). Any need for
        additional medication will be noted intraoperatively. Blood loss will be calculated by the
        gravimetric method and will be replaced if more than the allowable blood loss. Pain will be
        assessed using a visual analog scale (VRS) (O=no pain 1=mild pain 2=moderate pain 3=severe
        pain 4=unbearable pain).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Health Services Research
  masking: Double (Participant, Investigator)
  measure: the onset of the femoral nerve block
  time frame: from the deposition of the local anesthetic till the loss of pinprick sensation
  description: The time interval between the deposition of the local anesthetic and the loss of pinprick sensation at the site of surgery.
  arm group label: Ketamine group (group K)
  arm group type: Active Comparator
  description: Ketamine group (group K):40 ml 0.5%bupivacaine and 0.5 mg\kg ketamine.
  arm group label: Dexmedetomidine group (group D)
  arm group type: Active Comparator
  description: Dexmedetomidine group (group D) 40 ml 0.5% bupivacaine and 50µg\kg dexmedetomidine.
  intervention type: Procedure
  intervention name: combined ultra-sound guided femoral and sciatic nerve block.
  description: Femoral nerve block, The femoral area will be scanned behind the midpoint of the inguinal ligament and the depth of the image will be set at 3-5 cm, and a linear high frequency 8-12MHz) probe will be placed perpendicular to the course of the femoral nerve., the volume of 15 ml of bupivacaine will be injected to perform the block. Sciatic nerve block, A curvilinear low-frequency (3-9 MHz) probe will be used to do a scan of the sub-gluteal region below a line from the ischial tuberosity and greater trochanter which are seen as two hyperechoic bony prominences,A volume of 25 ml of bupivacaine will be injected to perform the block.
  arm group label: Dexmedetomidine group (group D)
  arm group label: Ketamine group (group K)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Mohammed Mahmoud, MD
  phone: 00201091328413
  email: mohamedmahmoud@med.sohag.edu.eg
  responsible party type: Principal Investigator
  investigator affiliation: Sohag University
  investigator full name: Mohammed Ahmed Mahmoud
  investigator title: Lecturer
  mesh term: Pain, Postoperative