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/NCT05998551</url>
    </required_header>
    <id_info>
      <org_study_id>intra-thecal analgesia</org_study_id>
      <nct_id>NCT05998551</nct_id>
    </id_info>
    <brief_title>Single Shot Intrathecal Analgesia in Vaginal Delivery</brief_title>
    <official_title>Effectiveness of Single Shot Intra-thecal Analgesia in Multiparous Women Scheduled for Normal Vaginal Delivery.</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>
      <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>
        Effectiveness of single shot intra-thecal analgesia in multiparous women scheduled for normal&#xD;
        vaginal delivery&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Labor is a physiological and natural process, as well as a complicated and subjective&#xD;
        experience.Except for a few women, childbirth is unquestionably a painful experience. Women's&#xD;
        understanding of delivery's pain is influenced by various factors, making each experience&#xD;
        special. As opposed to other painful life events, labor pain consistently ranks high on the&#xD;
        pain rating scale.&#xD;
  &#xD;
        In this study ,the investigators are going to investigate the effectiveness and safety of&#xD;
        intrathecal analgesia for labour using bupivacaine with fentanyl or dexmedetomidine.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 1, 2023</start_date>
    <completion_date type="Anticipated">October 1, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2023</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>
      <intervention_model_description>The eligible parturients will be randomly allocated into three groups according to the additive added to a fixed dose of local anesthetic (1ml=5mg of 0.5% hyperbaric bupivacaine).Total volume of 2 ml will be given to each patient</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
      <masking_description>Computer generated number lists and use of sealed opaque envelopes , double blinded trial</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Duration of pain relief</measure>
      <time_frame>Up to 6 hours after intrathecal injection</time_frame>
      <description>The duration of pain relief will be defined as the duration from intrathecal injection till the VAS became more than 4</description>
    </primary_outcome>
    <primary_outcome>
      <measure>analgesic onset time</measure>
      <time_frame>within 15 minutes after intrathecal injection</time_frame>
      <description>The analgesia onset time will be defined as the time from intrathecal injection until the VAS became less than 4</description>
    </primary_outcome>
    <primary_outcome>
      <measure>maximum level of sensory block</measure>
      <time_frame>15 min after the intrathecal injection</time_frame>
      <description>Temperature will be assessed using methylated soaked swabs on both sides of the body</description>
    </primary_outcome>
    <primary_outcome>
      <measure>visual analogue scale (VAS) of the labour pain</measure>
      <time_frame>6 hours after intrathecal injection</time_frame>
      <description>The VAS (ranging from 0 = pain-free up to 10 = worst imaginable pain) of the labour pain will be recorded before the intrathecal injection, every 5 min for the first 20 min, then every 30 min for 6 hours</description>
    </primary_outcome>
    <primary_outcome>
      <measure>S1 regression time</measure>
      <time_frame>6 hours after intrathecal injection</time_frame>
      <description>S1 regression time will be defined as the time from intrathecal injection to sensory regression to S1 dermatome</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Maternal blood pressure</measure>
      <time_frame>6 hours post operative</time_frame>
      <description>any change more than 20% of baseline mean arterial pressure</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Maternal heart rate</measure>
      <time_frame>6 hours post operative</time_frame>
      <description>any change more than 20% of baseline heart rate</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Post operative nausea and vomiting</measure>
      <time_frame>6 hours post operative</time_frame>
      <description>Number of participants having post operative nausea and vomiting</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Post operative urinary retention</measure>
      <time_frame>6 hours post operative</time_frame>
      <description>Number of participants having post operative urinary retention</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fetal heart sounds</measure>
      <time_frame>from intrathecal injection till delivery</time_frame>
      <description>Change more than 20% of fetal heart sounds before delivery</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fetal APGAR score</measure>
      <time_frame>till 5 minutes after delivery</time_frame>
      <description>APGAR score (1) color, 2) heart rate, 3) reflexes, 4) muscle tone, and 5) respiration, each of which is given a score of 0, 1, or 2 at 1 and 5 minutes after delivery</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">75</enrollment>
    <condition>Effectiveness of Single Shot Intra-thecal Analgesia in Multiparous Women Scheduled for Normal Vaginal Delivery</condition>
    <arm_group>
      <arm_group_label>Dexmedetomidine Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>participants will receive intrathecal injection of 5mg (1ml) of 0.5% hyperbaric bupivacaine + 1 ml contain 5μg dexmedetomidine(0.05ml dexmedetomidine in insulin syringe+ 0.95ml normal saline).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Fentanyl group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>participants will receive intrathecal injection of 5 mg (1ml) of 0.5% hyperbaric bupivacaine + 1 ml contain 12.5μg fentanyl(0.25ml fentanyl in insulin syringe+ 0.75ml normal saline).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>participants will receive intrathecal injection of 5mg (1ml) of 0.5% hyperbaric bupivacaine + 1 ml normal saline</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Dexmedetomidine</intervention_name>
      <description>intrathecal injection of dexmedetomidine added to hyperbaric bupivacaine</description>
      <arm_group_label>Dexmedetomidine Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Fentanyl</intervention_name>
      <description>intrathecal injection of fentanyl added to hyperbaric bupivacaine</description>
      <arm_group_label>Fentanyl group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Bupivacaine Hcl 0.5% Inj</intervention_name>
      <description>intrathecal injection of hyperbaric bupivacaine only</description>
      <arm_group_label>Control group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          -  Inclusion criteria:&#xD;
  &#xD;
                 -  Multiparous women who received antenatal care, presented for vaginal delivery of&#xD;
                    uncomplicated term pregnancy of singleton fetus with engaged fetal head and&#xD;
                    cervical dilatation of at least 5 cm requiring oxytocin augmentation, and&#xD;
                    requested analgesia.&#xD;
  &#xD;
                 -  Age: patients between 22-45 years old.&#xD;
  &#xD;
            -  Exclusion criteria:&#xD;
  &#xD;
                 -  Refusal of procedure or participation in the study.&#xD;
  &#xD;
                 -  Patients with pre-existing or pregnancy-induced hypertension, abnormal fetal&#xD;
                    heart rate tracings, obesity, endocrinal diseases and/or diagnosed fetal&#xD;
                    abnormalities.&#xD;
  &#xD;
                 -  Contraindication to neuraxial block.&#xD;
  &#xD;
                 -  Allergy to any of the study drugs.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>22 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Mohamed Nagdy Rashad</last_name>
      <phone>01095825826</phone>
      <email>mohamed.nagdy@med.asu.edu.eg</email>
    </overall_contact>
    <location>
      <facility>
        <name>Ainshams University</name>
        <address>
          <city>Cairo</city>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>ainshams university</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>May 2023</verification_date>
    <study_first_submitted>June 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Agnosia</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Fentanyl</mesh_term>
      <mesh_term>Dexmedetomidine</mesh_term>
      <mesh_term>Bupivacaine</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT05998551
  org study id: intra-thecal analgesia
  nct id: NCT05998551
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  Effectiveness of single shot intra-thecal analgesia in multiparous women scheduled for normal
        vaginal delivery
  Labor is a physiological and natural process, as well as a complicated and subjective
        experience.Except for a few women, childbirth is unquestionably a painful experience. Women's
        understanding of delivery's pain is influenced by various factors, making each experience
        special. As opposed to other painful life events, labor pain consistently ranks high on the
        pain rating scale.
  
        In this study ,the investigators are going to investigate the effectiveness and safety of
        intrathecal analgesia for labour using bupivacaine with fentanyl or dexmedetomidine.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: The eligible parturients will be randomly allocated into three groups according to the additive added to a fixed dose of local anesthetic (1ml=5mg of 0.5% hyperbaric bupivacaine).Total volume of 2 ml will be given to each patient
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  masking description: Computer generated number lists and use of sealed opaque envelopes , double blinded trial
  measure: Duration of pain relief
  time frame: Up to 6 hours after intrathecal injection
  description: The duration of pain relief will be defined as the duration from intrathecal injection till the VAS became more than 4
  measure: analgesic onset time
  time frame: within 15 minutes after intrathecal injection
  description: The analgesia onset time will be defined as the time from intrathecal injection until the VAS became less than 4
  measure: maximum level of sensory block
  time frame: 15 min after the intrathecal injection
  description: Temperature will be assessed using methylated soaked swabs on both sides of the body
  measure: visual analogue scale (VAS) of the labour pain
  time frame: 6 hours after intrathecal injection
  description: The VAS (ranging from 0 = pain-free up to 10 = worst imaginable pain) of the labour pain will be recorded before the intrathecal injection, every 5 min for the first 20 min, then every 30 min for 6 hours
  measure: S1 regression time
  time frame: 6 hours after intrathecal injection
  description: S1 regression time will be defined as the time from intrathecal injection to sensory regression to S1 dermatome
  measure: Maternal blood pressure
  time frame: 6 hours post operative
  description: any change more than 20% of baseline mean arterial pressure
  measure: Maternal heart rate
  time frame: 6 hours post operative
  description: any change more than 20% of baseline heart rate
  measure: Post operative nausea and vomiting
  time frame: 6 hours post operative
  description: Number of participants having post operative nausea and vomiting
  measure: Post operative urinary retention
  time frame: 6 hours post operative
  description: Number of participants having post operative urinary retention
  measure: Fetal heart sounds
  time frame: from intrathecal injection till delivery
  description: Change more than 20% of fetal heart sounds before delivery
  measure: Fetal APGAR score
  time frame: till 5 minutes after delivery
  description: APGAR score (1) color, 2) heart rate, 3) reflexes, 4) muscle tone, and 5) respiration, each of which is given a score of 0, 1, or 2 at 1 and 5 minutes after delivery
  arm group label: Dexmedetomidine Group
  arm group type: Active Comparator
  description: participants will receive intrathecal injection of 5mg (1ml) of 0.5% hyperbaric bupivacaine + 1 ml contain 5μg dexmedetomidine(0.05ml dexmedetomidine in insulin syringe+ 0.95ml normal saline).
  arm group label: Fentanyl group
  arm group type: Active Comparator
  description: participants will receive intrathecal injection of 5 mg (1ml) of 0.5% hyperbaric bupivacaine + 1 ml contain 12.5μg fentanyl(0.25ml fentanyl in insulin syringe+ 0.75ml normal saline).
  arm group label: Control group
  arm group type: Active Comparator
  description: participants will receive intrathecal injection of 5mg (1ml) of 0.5% hyperbaric bupivacaine + 1 ml normal saline
  intervention type: Drug
  intervention name: Dexmedetomidine
  description: intrathecal injection of dexmedetomidine added to hyperbaric bupivacaine
  arm group label: Dexmedetomidine Group
  intervention type: Drug
  intervention name: Fentanyl
  description: intrathecal injection of fentanyl added to hyperbaric bupivacaine
  arm group label: Fentanyl group
  intervention type: Drug
  intervention name: Bupivacaine Hcl 0.5% Inj
  description: intrathecal injection of hyperbaric bupivacaine only
  arm group label: Control group
  criteria: 
  gender: Female
  minimum age: 22 Years
  maximum age: 45 Years
  healthy volunteers: No
  last name: Mohamed Nagdy Rashad
  phone: 01095825826
  email: mohamed.nagdy@med.asu.edu.eg
  facility: 
  status: Recruiting
  contact: 
  country: Egypt
  responsible party type: Sponsor
  mesh term: Agnosia
  mesh term: Fentanyl
  mesh term: Dexmedetomidine
  mesh term: Bupivacaine
  sharing ipd: Undecided