<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/NCT04464616</url>
  </required_header>
  <id_info>
    <org_study_id>spinal additives in CS</org_study_id>
    <nct_id>NCT04464616</nct_id>
  </id_info>
  <brief_title>Adding Different Additives to Bupivacaine-fentanyl Mixture in Spinal Anesthesia for Cesarean Section</brief_title>
  <official_title>The Effect of Adding Dexmedetomidine or Dexamethasone to Bupivacaine-Fentanyl Mixture in Spinal Anesthesia for Cesarean Section</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tanta University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tanta University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Spinal anesthesia is widely used in cesarean section, but it is associated with high&#xD;
      incidence of side effects. To reduce the occurrence of side effects, intrathecal adjuvant was&#xD;
      recommended to use in spinal anesthesia, with the aim in reducing the dose of intrathecal&#xD;
      local anesthetic, which can subsequently decrease the incidence of spinal-induced side&#xD;
      effects and prolong postoperative analgesia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Spinal anesthesia is widely used in cesarean section, but it is associated with high&#xD;
      incidence of side effects. To reduce the occurrence of side effects, intrathecal adjuvant was&#xD;
      recommended to use in spinal anesthesia, with the aim in reducing the dose of intrathecal&#xD;
      local anesthetic, which can subsequently decrease the incidence of spinal-induced side&#xD;
      effects and prolong postoperative analgesia.Many augmentation strategies for intrathecal&#xD;
      analgesia have been proposed. A meta-analysis by Popping et al. concluded that the&#xD;
      concomitant use of an opioid such as fentanyl intrathecally allows the reduction in the dose&#xD;
      of local anesthetic, while augmenting its analgesic potency thereby decreasing its adverse&#xD;
      effects.&#xD;
&#xD;
      Dexamethasone relieves pain through reducing inflammation and blocking of nociceptive C-&#xD;
      fibers transmission and by suppressing neural ectopic discharge. Post-operative analgesic&#xD;
      effectiveness and duration was prolonged when dexamethasone was used as an adjunct for&#xD;
      peripheral nerve blocks. Recent studies reported no complications associated with intrathecal&#xD;
      dexamethasone.&#xD;
&#xD;
      Dexmedetomidine (DEX) is a potent, selective α2 adrenergic agonist and when given&#xD;
      intrathecally, it exerts its analgesic effect via stimulating spinal α2 receptors. Wu et al.,&#xD;
      in their meta-analysis showed that addition of intrathecal DEX significantly increased the&#xD;
      duration of postoperative analgesia and reduced analgesic consumption. The increase in&#xD;
      duration of postoperative analgesia is dose dependent but with increase in the incidence of&#xD;
      bradycardia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 15, 2020</start_date>
  <completion_date type="Actual">January 20, 2021</completion_date>
  <primary_completion_date type="Actual">December 15, 2020</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>Supportive Care</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>time for the first request of rescue analgesia</measure>
    <time_frame>postoperative first day</time_frame>
    <description>time for the first request of rescue morphine analgesia at dose of 3 mg</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Numerical Rating Scale</measure>
    <time_frame>postoperative first day</time_frame>
    <description>Numerical Rating Scale (NRS) for pain that ranged from (0 = no pain) to (10 = intolerable pain). If score is &gt;3 will need analgesia in the form of morphine 3 mg will be given till NRS decreases to ≤3. NRS will be assessed and recorded immediately postoperative, 2, 4, 8, 12, 18, 24 h after the operation, by an anesthesiologist, who is blinded to the study groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal satisfaction</measure>
    <time_frame>postoperative first day</time_frame>
    <description>Maternal satisfaction will be evaluated on a 0-3 score (0 = poor, 1 = fair, 2 = good, and 3 = excellent).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal outcome</measure>
    <time_frame>time of delivery of fetus</time_frame>
    <description>Neonatal outcome will be assessed in terms of Apgar score.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>spinal anesthesia with 10 mg hyperbaric bupivacaine 5% (2 ml) + 25 μg fentanyl (0.5 ml) + normal saline (0.5 ml).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dexmedetomidine group):</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>spinal anesthesia with 10 mg hyperbaric bupivacaine 5% (2 ml) + 25 μg fentanyl (0.5 ml) + 5 μg dexmedetomidine in a volume of (0.5 ml).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dexamethasone group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>spinal anaesthesia with 10 mg hyperbaric bupivacaine 5% (2 ml) + 25 μg fentanyl (0.5 ml) + 2 mg dexamethasone in a volume of 0.5 ml).</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>spinal anaesthesia</intervention_name>
    <description>spinal anaesthesia will be performed with the patient in sitting position at the L3-L4 or L4-L5 interspaces with a 25 or 27 G spinal tip needle with the study drug in the total volume of 3 ml.</description>
    <arm_group_label>Dexamethasone group</arm_group_label>
    <arm_group_label>Dexmedetomidine group):</arm_group_label>
    <arm_group_label>control group</arm_group_label>
    <other_name>intrathecal anaesthesia</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  90 parturient&#xD;
&#xD;
          -  the statue of American Society of Anesthesiologists' physical class II&#xD;
&#xD;
          -  prepared for an elective cesarean section.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  BMI &gt; 35kg/m2&#xD;
&#xD;
          -  gestational age &lt; 28 weeks&#xD;
&#xD;
          -  diabetes or gestational diabetes&#xD;
&#xD;
          -  hypertension or pre-eclampsia&#xD;
&#xD;
          -  contraindications to spinal anesthesia&#xD;
&#xD;
          -  height less than 160 Cm&#xD;
&#xD;
          -  history of psychiatric disease&#xD;
&#xD;
          -  taking α-receptor antagonist drugs -a history of allergy to the study drugs-&#xD;
&#xD;
          -  excessive hemorrhage needing transfusion.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Tarek Abdel Hay</name>
      <address>
        <city>Tanta</city>
        <state>El Gharbyia</state>
        <zip>31527</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>February 15, 2021</last_update_submitted>
  <last_update_submitted_qc>February 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tanta University</investigator_affiliation>
    <investigator_full_name>tarek abdel hay mostafa</investigator_full_name>
    <investigator_title>principle investigator</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</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/NCT04464616
org study id: spinal additives in CS
nct id: NCT04464616
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Spinal anesthesia is widely used in cesarean section, but it is associated with high
      incidence of side effects. To reduce the occurrence of side effects, intrathecal adjuvant was
      recommended to use in spinal anesthesia, with the aim in reducing the dose of intrathecal
      local anesthetic, which can subsequently decrease the incidence of spinal-induced side
      effects and prolong postoperative analgesia.
Spinal anesthesia is widely used in cesarean section, but it is associated with high
      incidence of side effects. To reduce the occurrence of side effects, intrathecal adjuvant was
      recommended to use in spinal anesthesia, with the aim in reducing the dose of intrathecal
      local anesthetic, which can subsequently decrease the incidence of spinal-induced side
      effects and prolong postoperative analgesia.Many augmentation strategies for intrathecal
      analgesia have been proposed. A meta-analysis by Popping et al. concluded that the
      concomitant use of an opioid such as fentanyl intrathecally allows the reduction in the dose
      of local anesthetic, while augmenting its analgesic potency thereby decreasing its adverse
      effects.

      Dexamethasone relieves pain through reducing inflammation and blocking of nociceptive C-
      fibers transmission and by suppressing neural ectopic discharge. Post-operative analgesic
      effectiveness and duration was prolonged when dexamethasone was used as an adjunct for
      peripheral nerve blocks. Recent studies reported no complications associated with intrathecal
      dexamethasone.

      Dexmedetomidine (DEX) is a potent, selective α2 adrenergic agonist and when given
      intrathecally, it exerts its analgesic effect via stimulating spinal α2 receptors. Wu et al.,
      in their meta-analysis showed that addition of intrathecal DEX significantly increased the
      duration of postoperative analgesia and reduced analgesic consumption. The increase in
      duration of postoperative analgesia is dose dependent but with increase in the incidence of
      bradycardia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: time for the first request of rescue analgesia
time frame: postoperative first day
description: time for the first request of rescue morphine analgesia at dose of 3 mg
measure: Numerical Rating Scale
time frame: postoperative first day
description: Numerical Rating Scale (NRS) for pain that ranged from (0 = no pain) to (10 = intolerable pain). If score is >3 will need analgesia in the form of morphine 3 mg will be given till NRS decreases to ≤3. NRS will be assessed and recorded immediately postoperative, 2, 4, 8, 12, 18, 24 h after the operation, by an anesthesiologist, who is blinded to the study groups.
measure: Maternal satisfaction
time frame: postoperative first day
description: Maternal satisfaction will be evaluated on a 0-3 score (0 = poor, 1 = fair, 2 = good, and 3 = excellent).
measure: Neonatal outcome
time frame: time of delivery of fetus
description: Neonatal outcome will be assessed in terms of Apgar score.
arm group label: control group
arm group type: Placebo Comparator
description: spinal anesthesia with 10 mg hyperbaric bupivacaine 5% (2 ml) + 25 μg fentanyl (0.5 ml) + normal saline (0.5 ml).
arm group label: Dexmedetomidine group):
arm group type: Experimental
description: spinal anesthesia with 10 mg hyperbaric bupivacaine 5% (2 ml) + 25 μg fentanyl (0.5 ml) + 5 μg dexmedetomidine in a volume of (0.5 ml).
arm group label: Dexamethasone group
arm group type: Experimental
description: spinal anaesthesia with 10 mg hyperbaric bupivacaine 5% (2 ml) + 25 μg fentanyl (0.5 ml) + 2 mg dexamethasone in a volume of 0.5 ml).
intervention type: Procedure
intervention name: spinal anaesthesia
description: spinal anaesthesia will be performed with the patient in sitting position at the L3-L4 or L4-L5 interspaces with a 25 or 27 G spinal tip needle with the study drug in the total volume of 3 ml.
arm group label: Dexamethasone group
arm group label: Dexmedetomidine group):
arm group label: control group
other name: intrathecal anaesthesia
criteria: 
gender: Female
gender based: Yes
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Tanta University
investigator full name: tarek abdel hay mostafa
investigator title: principle investigator
mesh term: Pain, Postoperative
mesh term: Anesthetics