<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/NCT03264430</url>
  </required_header>
  <id_info>
    <org_study_id>17100219</org_study_id>
    <nct_id>NCT03264430</nct_id>
  </id_info>
  <brief_title>Adding Ketamine to Low Dose Bupivacaine in Saddle Block for Perianal Surgery</brief_title>
  <official_title>Adding Ketamine to Low Dose Bupivacaine in Saddle Block for Perianal Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Esam Eldin Mohamed Abdalla</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut 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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluation of the anesthetic quality and analgesic efficacy of adding ketamine to intrathecal&#xD;
      bupivavaine in selective saddle block for perianal surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be carried out in Assiut University Hospitals, General Surgery Operative room&#xD;
      and Post Anaesthesia Care Unit (PACU).&#xD;
&#xD;
      This study will include 60 adult participants (ASA I&amp;II) scheduled for minor perianal surgery&#xD;
      (perianal fistula, haemorrhoids or both). After approval of ethics committee and written&#xD;
      informed consent will be obtained from the participants.&#xD;
&#xD;
      Investigators will exclude participants with classic contraindications to spinal block,&#xD;
      pre-existing systemic disease (such as cardiovascular, respiratory or renal diseases),&#xD;
      coagulopathy and participants taking any medications that could influence the haemodynamic&#xD;
      response.&#xD;
&#xD;
      The selected participants will be divide into two groups (30 participants for each group),&#xD;
      ketamine group and placebo (control) group.&#xD;
&#xD;
      The ketamine group will receive intrathecal bupivacaine (7.5 mg) in 1.5 ml (Marcaine, Astra&#xD;
      Zeneca, France, 0.5%) and ketamine (25mg) in 0.5 ml (Ketam, EIPICO, Egypt, 50 mg/mL),. Total&#xD;
      volume is 2 ml will injected. The control group will receive only intrathecal bupivacaine&#xD;
      (7.5 mg) in 1.5 ml plus 0.5ml normal saline to achieve total volume of 2 ml.&#xD;
&#xD;
      Anaesthetic technique&#xD;
&#xD;
      participants will receive oral medication 60 minutes preoperatively with 0.5 mg/kg of&#xD;
      midazolam.&#xD;
&#xD;
      After arrival at the OR, an intravenous (IV) 18-20G catheter was placed and infusion of 20&#xD;
      ml/kg NaCl 0.9% will start. Standard monitoring electrocardiogram (ECG), heart rate (HR),&#xD;
      oxygen saturation (SpO2), and non-invasive blood pressure (BP) will be started.&#xD;
&#xD;
      Dural puncture was made in the sitting position with a 25 gauge spinal needle using a median&#xD;
      approach. After aspiration, the dose of anaesthetic as indicated in the envelope was injected&#xD;
      over two minutes. The time of Dural puncture was used as the Primary starting point of&#xD;
      assessment. The medications injection will be over 10 s with no barbotage and the needle&#xD;
      orifice cephaled. After intrathecal injection, participants will kept sitting for 10 minutes,&#xD;
      after that the patient will lie in the lithotomy position and received 100% O2 (4 L/min) with&#xD;
      face mask.&#xD;
&#xD;
      Ten minutes after the Dural puncture, participants will asked to lie down and the level of&#xD;
      sensory block will tested with an alcohol swab. Motor block was tested by modified Bromage&#xD;
      scale (0 = no motor block, 1 = able to flex ankle and bend knees, 2 = able to flex ankle, and&#xD;
      3 = full motor block) [21], and surgery in the supine position will allow to started. In case&#xD;
      of failed block, general anaesthesia will be induced.&#xD;
&#xD;
      Non-invasive BP taken every 5 minutes and HR were assessed in the OR. Reduction of mean BP&#xD;
      (MAP) and HR &gt;20% from baseline was judged clinically significant. A decrease in systolic BP&#xD;
      below 90 mmHg will be treated with 5 mg of IV ephedrine, HR&lt;45 beats per minute (bpm) will be&#xD;
      treated with 0.5 mg of IV atropine.&#xD;
&#xD;
      Patient assessment:&#xD;
&#xD;
        -  Demographics (age, gender, type of surgery); duration of anesthesia (from the moment of&#xD;
           dural puncture until patient left the OR) and surgery in minutes.&#xD;
&#xD;
        -  Rate of success (failed block, number of attempts made, ease of performance scale 1-3,&#xD;
           where 3 = easy to perform, 2 =moderate, 1 = difficult, multiple attempts needed);&#xD;
&#xD;
        -  level of sensory (dermatomes) and motor (Bromage scale) block10 minutes after dural&#xD;
           puncture, at the end of surgery, and in the ward every 30 minutes until resolution of&#xD;
           the block and afterwards at 6, 9, 12, 18 and 24 hours postoperatively;&#xD;
&#xD;
        -  MAP and HR every 5 minutes in the OR, then every 4 hours for postoperative 24 hours;&#xD;
&#xD;
        -  Complications during performance of anesthesia: paresthesias, toxic reactions,&#xD;
&#xD;
        -  Level of postoperative pain on a written VAS scale (0-10 mm).&#xD;
&#xD;
        -  Time of 1st analgesic request, and number of requests for each patient will be recorded&#xD;
           in the 1st 24 hours.&#xD;
&#xD;
        -  Consumption of rescue analgesia; if VAS is ≥ 5 in the form of 30 mg intramuscular (IM)&#xD;
           repeated twice as patient satisfaction and 0.1mg of morphine for up stocking of pain&#xD;
&#xD;
        -  Postoperative complications:&#xD;
&#xD;
           - Urinary retention (0-2 scale, where 0 = normal urination, 1 = difficult spontaneous&#xD;
           urination, and 2 = unable to urinate, catheterization needed.&#xD;
&#xD;
        -  Postoperative nausea and vomiting (PONV; 0-3 scale, where 0 = no nausea, 1 = slight&#xD;
           nausea, 2 = nausea and single vomiting, and 3 = multiple vomiting) [15],&#xD;
&#xD;
        -  Postdural puncture headache (PDPH) at day 1 postoperatively and 10 days later by phone&#xD;
           call at home,&#xD;
&#xD;
        -  Transient neurologic symptoms (TNS), backache, itching, allergic reactions, time of&#xD;
           postoperative recovery, time to urinate, duration of sensory and motor block, and time&#xD;
           to stand and walk unsupported&#xD;
&#xD;
      Statistical analysis&#xD;
&#xD;
      The data will be recorded on and analyzed using SPSS-12. The results will be presented as&#xD;
      Mean ±SD or percent of patients. For proportions, Pearson test or Fisher's test will be used.&#xD;
      Student's t-test being used for quantitative variables. A p-value of &lt;0.05 will be considered&#xD;
      to show statistical significance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2018</completion_date>
  <primary_completion_date type="Anticipated">October 31, 2018</primary_completion_date>
  <phase>Early Phase 1</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>- Duration of saddle block</measure>
    <time_frame>24 hours post-operative</time_frame>
    <description>(time from intrathecal injection to the time of first complain of pain, first request for analgesia, or a reported NRS &gt;4)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the need of supplemental analgesia</measure>
    <time_frame>24 hours post-operative</time_frame>
    <description>time of 1st dose</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Perianal Fistula</condition>
  <condition>Hemorrhoids</condition>
  <arm_group>
    <arm_group_label>The ketamine group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The ketamine group will receive intrathecal bupivacaine (7.5 mg) in 1.5 ml (Marcaine, Astra Zeneca, France, 0.5%) and ketamine (25mg) in 0.5 ml (Ketam, EIPICO, Egypt, 50 mg/mL),. Total volume is 2 ml will injected</description>
  </arm_group>
  <arm_group>
    <arm_group_label>The control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>group will receive only intrathecal bupivacaine (7.5 mg) in 1.5 ml plus 0.5ml normal saline to achieve total volume of 2 ml.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ketamine</intervention_name>
    <description>an antagonist of the NMDA receptor</description>
    <arm_group_label>The ketamine group</arm_group_label>
    <other_name>ketalar</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>bupivacaine</intervention_name>
    <description>local anaesthetic</description>
    <arm_group_label>The control group</arm_group_label>
    <arm_group_label>The ketamine group</arm_group_label>
    <other_name>marcaine 0.5 %</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects will be included in the study only if they meet all of the following&#xD;
             criteria:&#xD;
&#xD;
          -  Patients scheduled for perianal surgeries.&#xD;
&#xD;
          -  Age 18-55 years.&#xD;
&#xD;
          -  ASA physical status I-II.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects will be excluded from the study for any of the following reasons:&#xD;
&#xD;
          -  Patient refusal&#xD;
&#xD;
          -  Any contraindication of regional anaesthesia&#xD;
&#xD;
          -  Failed Technique&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>May 29, 2017</study_first_submitted>
  <study_first_submitted_qc>August 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>January 13, 2018</last_update_submitted>
  <last_update_submitted_qc>January 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Esam Eldin Mohamed Abdalla</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>Perianal fistula</keyword>
  <keyword>Hemorrhoids</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemorrhoids</mesh_term>
    <mesh_term>Fistula</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ketamine</mesh_term>
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03264430
org study id: 17100219
nct id: NCT03264430
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Evaluation of the anesthetic quality and analgesic efficacy of adding ketamine to intrathecal
      bupivavaine in selective saddle block for perianal surgery.
This study will be carried out in Assiut University Hospitals, General Surgery Operative room
      and Post Anaesthesia Care Unit (PACU).

      This study will include 60 adult participants (ASA I&II) scheduled for minor perianal surgery
      (perianal fistula, haemorrhoids or both). After approval of ethics committee and written
      informed consent will be obtained from the participants.

      Investigators will exclude participants with classic contraindications to spinal block,
      pre-existing systemic disease (such as cardiovascular, respiratory or renal diseases),
      coagulopathy and participants taking any medications that could influence the haemodynamic
      response.

      The selected participants will be divide into two groups (30 participants for each group),
      ketamine group and placebo (control) group.

      The ketamine group will receive intrathecal bupivacaine (7.5 mg) in 1.5 ml (Marcaine, Astra
      Zeneca, France, 0.5%) and ketamine (25mg) in 0.5 ml (Ketam, EIPICO, Egypt, 50 mg/mL),. Total
      volume is 2 ml will injected. The control group will receive only intrathecal bupivacaine
      (7.5 mg) in 1.5 ml plus 0.5ml normal saline to achieve total volume of 2 ml.

      Anaesthetic technique

      participants will receive oral medication 60 minutes preoperatively with 0.5 mg/kg of
      midazolam.

      After arrival at the OR, an intravenous (IV) 18-20G catheter was placed and infusion of 20
      ml/kg NaCl 0.9% will start. Standard monitoring electrocardiogram (ECG), heart rate (HR),
      oxygen saturation (SpO2), and non-invasive blood pressure (BP) will be started.

      Dural puncture was made in the sitting position with a 25 gauge spinal needle using a median
      approach. After aspiration, the dose of anaesthetic as indicated in the envelope was injected
      over two minutes. The time of Dural puncture was used as the Primary starting point of
      assessment. The medications injection will be over 10 s with no barbotage and the needle
      orifice cephaled. After intrathecal injection, participants will kept sitting for 10 minutes,
      after that the patient will lie in the lithotomy position and received 100% O2 (4 L/min) with
      face mask.

      Ten minutes after the Dural puncture, participants will asked to lie down and the level of
      sensory block will tested with an alcohol swab. Motor block was tested by modified Bromage
      scale (0 = no motor block, 1 = able to flex ankle and bend knees, 2 = able to flex ankle, and
      3 = full motor block) [21], and surgery in the supine position will allow to started. In case
      of failed block, general anaesthesia will be induced.

      Non-invasive BP taken every 5 minutes and HR were assessed in the OR. Reduction of mean BP
      (MAP) and HR >20% from baseline was judged clinically significant. A decrease in systolic BP
      below 90 mmHg will be treated with 5 mg of IV ephedrine, HR<45 beats per minute (bpm) will be
      treated with 0.5 mg of IV atropine.

      Patient assessment:

        -  Demographics (age, gender, type of surgery); duration of anesthesia (from the moment of
           dural puncture until patient left the OR) and surgery in minutes.

        -  Rate of success (failed block, number of attempts made, ease of performance scale 1-3,
           where 3 = easy to perform, 2 =moderate, 1 = difficult, multiple attempts needed);

        -  level of sensory (dermatomes) and motor (Bromage scale) block10 minutes after dural
           puncture, at the end of surgery, and in the ward every 30 minutes until resolution of
           the block and afterwards at 6, 9, 12, 18 and 24 hours postoperatively;

        -  MAP and HR every 5 minutes in the OR, then every 4 hours for postoperative 24 hours;

        -  Complications during performance of anesthesia: paresthesias, toxic reactions,

        -  Level of postoperative pain on a written VAS scale (0-10 mm).

        -  Time of 1st analgesic request, and number of requests for each patient will be recorded
           in the 1st 24 hours.

        -  Consumption of rescue analgesia; if VAS is ≥ 5 in the form of 30 mg intramuscular (IM)
           repeated twice as patient satisfaction and 0.1mg of morphine for up stocking of pain

        -  Postoperative complications:

           - Urinary retention (0-2 scale, where 0 = normal urination, 1 = difficult spontaneous
           urination, and 2 = unable to urinate, catheterization needed.

        -  Postoperative nausea and vomiting (PONV; 0-3 scale, where 0 = no nausea, 1 = slight
           nausea, 2 = nausea and single vomiting, and 3 = multiple vomiting) [15],

        -  Postdural puncture headache (PDPH) at day 1 postoperatively and 10 days later by phone
           call at home,

        -  Transient neurologic symptoms (TNS), backache, itching, allergic reactions, time of
           postoperative recovery, time to urinate, duration of sensory and motor block, and time
           to stand and walk unsupported

      Statistical analysis

      The data will be recorded on and analyzed using SPSS-12. The results will be presented as
      Mean ±SD or percent of patients. For proportions, Pearson test or Fisher's test will be used.
      Student's t-test being used for quantitative variables. A p-value of <0.05 will be considered
      to show statistical significance.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Triple (Participant, Care Provider, Investigator)
measure: - Duration of saddle block
time frame: 24 hours post-operative
description: (time from intrathecal injection to the time of first complain of pain, first request for analgesia, or a reported NRS >4)
measure: Evaluation of the need of supplemental analgesia
time frame: 24 hours post-operative
description: time of 1st dose
arm group label: The ketamine group
arm group type: Active Comparator
description: The ketamine group will receive intrathecal bupivacaine (7.5 mg) in 1.5 ml (Marcaine, Astra Zeneca, France, 0.5%) and ketamine (25mg) in 0.5 ml (Ketam, EIPICO, Egypt, 50 mg/mL),. Total volume is 2 ml will injected
arm group label: The control group
arm group type: Placebo Comparator
description: group will receive only intrathecal bupivacaine (7.5 mg) in 1.5 ml plus 0.5ml normal saline to achieve total volume of 2 ml.
intervention type: Drug
intervention name: Ketamine
description: an antagonist of the NMDA receptor
arm group label: The ketamine group
other name: ketalar
intervention type: Drug
intervention name: bupivacaine
description: local anaesthetic
arm group label: The control group
arm group label: The ketamine group
other name: marcaine 0.5 %
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor-Investigator
investigator affiliation: Assiut University
investigator full name: Esam Eldin Mohamed Abdalla
investigator title: Clinical Professor
mesh term: Hemorrhoids
mesh term: Fistula
mesh term: Ketamine
mesh term: Bupivacaine
sharing ipd: No