<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/NCT04480775</url>
  </required_header>
  <id_info>
    <org_study_id>(MS.20.01.999-2020/01/10)</org_study_id>
    <nct_id>NCT04480775</nct_id>
  </id_info>
  <brief_title>Triamcinolone Versus Methylprednisolone in Transversus Abdominis Plane Block</brief_title>
  <acronym>triamcinolone</acronym>
  <official_title>Triamcinolone Versus Methylprednisolone in Ultrasound Guided Transversus Abdominis Plane Block in Major Open Abdominal Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ghada fouad</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mansoura 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>
      In the current Study we will compare between triamcinolone and methylprednisolone as an&#xD;
      additive to bupivacaine drug in ultrasound guided TAP block in major open abdominal surgery .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Postoperative pain is one of the main causes of respiratory function derangement after&#xD;
      abdominal surgery .Transversus abdominis plane (TAP) block is widely used in abdominal&#xD;
      surgery for postoperative analgesia The transversus abdominis plane (TAP) block is&#xD;
      aperipheral nerve block that involves the injection of alocal anesthetic (LA) in the plane&#xD;
      between the internaloblique and transversus abdominis muscle layers, with the aim of&#xD;
      anesthetizing the intercostal nerves supplyingthe abdominal wall (from T6 to L1) By blocking&#xD;
      intercostal nerves T6 to L1, TAPblock efficiently blocks somatic pain after abdominalwall&#xD;
      surgery&#xD;
&#xD;
      . It providesadequate postoperative pain relief following various abdominal surgeries TAP&#xD;
      block can reduce pain scores, opioid consumption, and the incidence of opioid-related&#xD;
      complications after abdominal surgery.&#xD;
&#xD;
      The duration of the TAP block is limited to theeffect of the administered LAs. Various&#xD;
      adjuvantmedications have been added to the LA to prolong theduration of TAP block and magnify&#xD;
      its effects .&#xD;
&#xD;
      Perineural injection of steroids is reported to influence postoperative analgesia.&#xD;
&#xD;
      As a synthetic glucocorticoid, triamcinolone acetonide binds to and activates the&#xD;
      glucocorticoid receptor to produce anti-inflammatory responses,such as down-regulating&#xD;
      pro-inflammatory cytokine expression , preventing prostaglandin and leukotriene synthesis and&#xD;
      release of arachidonic acid, and activating anti-inflammatory transcription factors such as&#xD;
      lipocortins&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 15, 2020</start_date>
  <completion_date type="Actual">December 15, 2020</completion_date>
  <primary_completion_date type="Actual">December 15, 2020</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Patient will be evaluated pre operative and full lab will be done In the Pre Anaesthesia Room ,a 20 gauge venous catheter will be inserted in the upper limb , and monitoring included heart rate, electrocardiogram, noninvasiveblood pressure, and peripheral oxygen saturation.Oxygen at the rate of 6 L/min will beadministered through oxygen mask to all patients.&#xD;
The anesthesiologist who performed the block will be blinded to drug solution and not involved in data collection, another anesthesiologist will prepare drug solution and other anesthesiologist collect the data.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>double blinded</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>analgesic effect of Triamcinolone and Methylprednisolone In Ultrasound Guided Transversus Abdominis Plane Block ( Tap Block ).</measure>
    <time_frame>24 hours after surgery</time_frame>
    <description>visual analogue scale for assessement of pain from 0 to 10 is used where 0 is no pain and 10 is maximum pain</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>occurance of complication</measure>
    <time_frame>24 hours after surgery</time_frame>
    <description>nausea vomiting hemodynamic changes</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">84</enrollment>
  <condition>Major Abdominal Surgery</condition>
  <arm_group>
    <arm_group_label>bupivacaine group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>28 Patients will receive 18 ml of bupivacaine 0.5 % plus 1ml 0.9% saline in TAP block divided equally on both sides</description>
  </arm_group>
  <arm_group>
    <arm_group_label>triamicinolone group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>28 Patient will receive 18 ml of bupivacaine 0.5 % plus (20 mg of triamcinolone in 1ml 0.9% saline divided equally on both sides in TAP block</description>
  </arm_group>
  <arm_group>
    <arm_group_label>methylprednisolone group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>28 Patient will receive 18 ml of bupivacaine 0.5 % plus (40 mg of methylprednisolone in 1ml 0.9% saline ) on both sides in TAP block.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Triamcinolone</intervention_name>
    <description>transversus abdominis plane block with bupivacain and triamicinolone</description>
    <arm_group_label>triamicinolone group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Methylprednisolone</intervention_name>
    <description>transversus abdominis plane block with bupivacaine and methylprednisolone</description>
    <arm_group_label>methylprednisolone group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>bupivacaine</intervention_name>
    <description>transversus abdominis plane block with bupivacaine alone</description>
    <arm_group_label>bupivacaine group</arm_group_label>
    <arm_group_label>methylprednisolone group</arm_group_label>
    <arm_group_label>triamicinolone group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients scheduled for major open abdominal surgery&#xD;
&#xD;
          -  American Society Anesthesiologists (ASA) physical status I to II&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient refusal.&#xD;
&#xD;
          -  Morbidly obese patients.&#xD;
&#xD;
          -  Patients with uncontrolled diabetes.&#xD;
&#xD;
          -  Severe or uncontrolled renal, hepatic or endocrinal diseases.&#xD;
&#xD;
          -  Pregnancy, post-partum or lactating females&#xD;
&#xD;
          -  Allergy to one of the agents used.&#xD;
&#xD;
          -  Recent (less than six months) use of glucocorticoids for at least two weeks&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>marwa M elegemazy, master</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mansoura University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>ghada f amer, M.D</last_name>
    <role>Study Director</role>
    <affiliation>associate professor of anesthesia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Eiad a ramzy, M.D</last_name>
    <role>Study Chair</role>
    <affiliation>associate professor of anesthesia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>abdelaziz a motaweaa, M.D</last_name>
    <role>Study Chair</role>
    <affiliation>professor of anesthesia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mansoura University</name>
      <address>
        <city>Mansoura</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>March 2, 2021</last_update_submitted>
  <last_update_submitted_qc>March 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Mansoura University</investigator_affiliation>
    <investigator_full_name>ghada fouad</investigator_full_name>
    <investigator_title>associate professor</investigator_title>
  </responsible_party>
  <keyword>triamicinolone</keyword>
  <keyword>methylprednisolone</keyword>
  <keyword>transversus abdominisus plane block</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Methylprednisolone</mesh_term>
    <mesh_term>Methylprednisolone Acetate</mesh_term>
    <mesh_term>Methylprednisolone Hemisuccinate</mesh_term>
    <mesh_term>Prednisolone</mesh_term>
    <mesh_term>Prednisolone acetate</mesh_term>
    <mesh_term>Triamcinolone</mesh_term>
    <mesh_term>Bupivacaine</mesh_term>
    <mesh_term>Prednisolone hemisuccinate</mesh_term>
    <mesh_term>Prednisolone phosphate</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/NCT04480775
org study id: (MS.20.01.999-2020/01/10)
nct id: NCT04480775
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In the current Study we will compare between triamcinolone and methylprednisolone as an
      additive to bupivacaine drug in ultrasound guided TAP block in major open abdominal surgery .
Postoperative pain is one of the main causes of respiratory function derangement after
      abdominal surgery .Transversus abdominis plane (TAP) block is widely used in abdominal
      surgery for postoperative analgesia The transversus abdominis plane (TAP) block is
      aperipheral nerve block that involves the injection of alocal anesthetic (LA) in the plane
      between the internaloblique and transversus abdominis muscle layers, with the aim of
      anesthetizing the intercostal nerves supplyingthe abdominal wall (from T6 to L1) By blocking
      intercostal nerves T6 to L1, TAPblock efficiently blocks somatic pain after abdominalwall
      surgery

      . It providesadequate postoperative pain relief following various abdominal surgeries TAP
      block can reduce pain scores, opioid consumption, and the incidence of opioid-related
      complications after abdominal surgery.

      The duration of the TAP block is limited to theeffect of the administered LAs. Various
      adjuvantmedications have been added to the LA to prolong theduration of TAP block and magnify
      its effects .

      Perineural injection of steroids is reported to influence postoperative analgesia.

      As a synthetic glucocorticoid, triamcinolone acetonide binds to and activates the
      glucocorticoid receptor to produce anti-inflammatory responses,such as down-regulating
      pro-inflammatory cytokine expression , preventing prostaglandin and leukotriene synthesis and
      release of arachidonic acid, and activating anti-inflammatory transcription factors such as
      lipocortins
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patient will be evaluated pre operative and full lab will be done In the Pre Anaesthesia Room ,a 20 gauge venous catheter will be inserted in the upper limb , and monitoring included heart rate, electrocardiogram, noninvasiveblood pressure, and peripheral oxygen saturation.Oxygen at the rate of 6 L/min will beadministered through oxygen mask to all patients.
The anesthesiologist who performed the block will be blinded to drug solution and not involved in data collection, another anesthesiologist will prepare drug solution and other anesthesiologist collect the data.
primary purpose: Prevention
masking: Double (Participant, Investigator)
masking description: double blinded
measure: analgesic effect of Triamcinolone and Methylprednisolone In Ultrasound Guided Transversus Abdominis Plane Block ( Tap Block ).
time frame: 24 hours after surgery
description: visual analogue scale for assessement of pain from 0 to 10 is used where 0 is no pain and 10 is maximum pain
measure: occurance of complication
time frame: 24 hours after surgery
description: nausea vomiting hemodynamic changes
arm group label: bupivacaine group
arm group type: Experimental
description: 28 Patients will receive 18 ml of bupivacaine 0.5 % plus 1ml 0.9% saline in TAP block divided equally on both sides
arm group label: triamicinolone group
arm group type: Active Comparator
description: 28 Patient will receive 18 ml of bupivacaine 0.5 % plus (20 mg of triamcinolone in 1ml 0.9% saline divided equally on both sides in TAP block
arm group label: methylprednisolone group
arm group type: Active Comparator
description: 28 Patient will receive 18 ml of bupivacaine 0.5 % plus (40 mg of methylprednisolone in 1ml 0.9% saline ) on both sides in TAP block.
intervention type: Drug
intervention name: Triamcinolone
description: transversus abdominis plane block with bupivacain and triamicinolone
arm group label: triamicinolone group
intervention type: Drug
intervention name: Methylprednisolone
description: transversus abdominis plane block with bupivacaine and methylprednisolone
arm group label: methylprednisolone group
intervention type: Drug
intervention name: bupivacaine
description: transversus abdominis plane block with bupivacaine alone
arm group label: bupivacaine group
arm group label: methylprednisolone group
arm group label: triamicinolone group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: No
last name: marwa M elegemazy, master
role: Principal Investigator
affiliation: Mansoura University
last name: ghada f amer, M.D
role: Study Director
affiliation: associate professor of anesthesia
last name: Eiad a ramzy, M.D
role: Study Chair
affiliation: associate professor of anesthesia
last name: abdelaziz a motaweaa, M.D
role: Study Chair
affiliation: professor of anesthesia
facility: 
country: Egypt
responsible party type: Sponsor-Investigator
investigator affiliation: Mansoura University
investigator full name: ghada fouad
investigator title: associate professor
mesh term: Methylprednisolone
mesh term: Methylprednisolone Acetate
mesh term: Methylprednisolone Hemisuccinate
mesh term: Prednisolone
mesh term: Prednisolone acetate
mesh term: Triamcinolone
mesh term: Bupivacaine
mesh term: Prednisolone hemisuccinate
mesh term: Prednisolone phosphate
sharing ipd: No