<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/NCT04445857</url>
  </required_header>
  <id_info>
    <org_study_id>IRB 6379</org_study_id>
    <nct_id>NCT04445857</nct_id>
  </id_info>
  <brief_title>Efficacy of Coadministration of Calcitonin and Hyperbaric Bupivacaine on Spinal Anesthesia in Tramadol-abuse Patients</brief_title>
  <official_title>Efficacy of Coadministration of Calcitonin and Hyperbaric Bupivacaine on Spinal Anesthesia in Lower Abdominal and Limb Surgeries in Tramadol-abuse Patients: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams University</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>
      Increasing duration of local anesthetic action is desired for prolongation of postoperative&#xD;
      patient comfort, as well as decreasing perioperative opioid consumption and subsequent side&#xD;
      effects. Calcitonin, discovered in 1961, has been established, synthesized, and developed for&#xD;
      use in treating disease. In 1983 it was demonstrated that calcitonin is an analgesic, which&#xD;
      is also effective in the epidural and subarachnoid spaces.Tramadol abuse has dramatically&#xD;
      increased in Egypt since 2008 and has led to many admissions to addiction treatment&#xD;
      centers.It was shown that the duration of sensory block of spinal anesthesia with hyperbaric&#xD;
      bupivacaine in chronic opium abusers undergoing lower extremity orthopedic surgery was much&#xD;
      shorter in chronic opium abusers compared with non-abusers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Actual">January 31, 2021</completion_date>
  <primary_completion_date type="Actual">January 31, 2021</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>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The length of the sensory block (min) of spinal anesthesia in tramadol-abuse patients intrathecally or i.v.</measure>
    <time_frame>procedure</time_frame>
    <description>The length of the sensory block (min) of spinal anesthesia in tramadol-abuse patients intrathecally or i.v.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Analgesia</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>injection of 15 mg (2.5 ml) hyperbaric bupivacaine 0.5% and 100 IU salmon calcitonin(1ml) intrathecally and injection of 10 ml normal saline (NS) slowly intravenously (IV) over 5 min.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>injection of 15 mg (2.5 ml) hyperbaric bupivacaine 0.5% and 1ml NS intrathecally and injection of 100 IU salmon calcitonin (1ml) diluted in 9 ml NS slowly IV over 5 min.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3 (control group)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>injection of 15 mg (2.5 ml) hyperbaric bupivacaine 0.5% and 1ml NS intrathecally and injection of 10 ml NS slowly IV over 5 min.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Calcitonin presented as Miacalcic® ampoules 100 IU/ml (1ml)</intervention_name>
    <description>coadministration of calcitonin and a single-shot hyperbaric bupivacaine prolongs the length of the sensory block (min) of SA in tramadol-abuse patients independent of the route of calcitonin administration intrathecally or i.v.</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>normal saline (NS)</intervention_name>
    <description>1ml NS intrathecally OR injection of 10 ml NS slowly IV over 5 min.</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_label>Group 3 (control group)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with history of substance use disorders (SUD) history of tramadol addiction&#xD;
             (single drug addiction and substances used besides tramadol) and duration of addiction&#xD;
             &gt;1 year&#xD;
&#xD;
          -  Elective lower abdomen or lower extremities surgeries under spinal anesthesia&#xD;
&#xD;
          -  ASA physical status I and II&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient's refusal,&#xD;
&#xD;
          -  duration of surgery more than 120 min,&#xD;
&#xD;
          -  obesity with body mass index (BMI) &gt;35 kg/m2,&#xD;
&#xD;
          -  generalized infection or localized infection at level of blockade,&#xD;
&#xD;
          -  neurological disease,&#xD;
&#xD;
          -  psychological disorder&#xD;
&#xD;
          -  coagulation disorder,&#xD;
&#xD;
          -  history of uncontrolled hypertension,&#xD;
&#xD;
          -  history of uncontrolled blood sugar,&#xD;
&#xD;
          -  allergy to bupivacaine or calcitonin&#xD;
&#xD;
          -  or failed spinal.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ibrahim Mamdouh Esmat</name>
      <address>
        <city>Cairo</city>
        <state>Married</state>
        <zip>11361</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>June 21, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>May 26, 2021</last_update_submitted>
  <last_update_submitted_qc>May 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Dr.Ibrahim Mamdouh Esmat</investigator_full_name>
    <investigator_title>Assistant Professor of Anesthesia and Intensive Care Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt.</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Calcitonin</mesh_term>
    <mesh_term>Salmon calcitonin</mesh_term>
    <mesh_term>Calcitonin Gene-Related Peptide</mesh_term>
    <mesh_term>Katacalcin</mesh_term>
  </intervention_browse>
  <!-- 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/NCT04445857
org study id: IRB 6379
nct id: NCT04445857
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Increasing duration of local anesthetic action is desired for prolongation of postoperative
      patient comfort, as well as decreasing perioperative opioid consumption and subsequent side
      effects. Calcitonin, discovered in 1961, has been established, synthesized, and developed for
      use in treating disease. In 1983 it was demonstrated that calcitonin is an analgesic, which
      is also effective in the epidural and subarachnoid spaces.Tramadol abuse has dramatically
      increased in Egypt since 2008 and has led to many admissions to addiction treatment
      centers.It was shown that the duration of sensory block of spinal anesthesia with hyperbaric
      bupivacaine in chronic opium abusers undergoing lower extremity orthopedic surgery was much
      shorter in chronic opium abusers compared with non-abusers.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: The length of the sensory block (min) of spinal anesthesia in tramadol-abuse patients intrathecally or i.v.
time frame: procedure
description: The length of the sensory block (min) of spinal anesthesia in tramadol-abuse patients intrathecally or i.v.
arm group label: Group 1
arm group type: Active Comparator
description: injection of 15 mg (2.5 ml) hyperbaric bupivacaine 0.5% and 100 IU salmon calcitonin(1ml) intrathecally and injection of 10 ml normal saline (NS) slowly intravenously (IV) over 5 min.
arm group label: Group 2
arm group type: Active Comparator
description: injection of 15 mg (2.5 ml) hyperbaric bupivacaine 0.5% and 1ml NS intrathecally and injection of 100 IU salmon calcitonin (1ml) diluted in 9 ml NS slowly IV over 5 min.
arm group label: Group 3 (control group)
arm group type: Placebo Comparator
description: injection of 15 mg (2.5 ml) hyperbaric bupivacaine 0.5% and 1ml NS intrathecally and injection of 10 ml NS slowly IV over 5 min.
intervention type: Drug
intervention name: Calcitonin presented as Miacalcic® ampoules 100 IU/ml (1ml)
description: coadministration of calcitonin and a single-shot hyperbaric bupivacaine prolongs the length of the sensory block (min) of SA in tramadol-abuse patients independent of the route of calcitonin administration intrathecally or i.v.
arm group label: Group 1
arm group label: Group 2
intervention type: Other
intervention name: normal saline (NS)
description: 1ml NS intrathecally OR injection of 10 ml NS slowly IV over 5 min.
arm group label: Group 1
arm group label: Group 2
arm group label: Group 3 (control group)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Dr.Ibrahim Mamdouh Esmat
investigator title: Assistant Professor of Anesthesia and Intensive Care Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt.
mesh term: Calcitonin
mesh term: Salmon calcitonin
mesh term: Calcitonin Gene-Related Peptide
mesh term: Katacalcin