<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/NCT04426617</url>
  </required_header>
  <id_info>
    <org_study_id>MS-258-2019</org_study_id>
    <nct_id>NCT04426617</nct_id>
  </id_info>
  <brief_title>Fentanyl Versus Midazolam As Additives To Bupivacaine In Ultrasound Guided Transversus Abdominis Plane Block</brief_title>
  <official_title>Comparison Between Fentanyl And Midazolam As Additives To Bupivacaine In Ultrasound Guided Transversus Abdominis Plane Block in Patients Undergoing Abdominal Surgeries; A Randomized Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo 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>
      Pain triggers a complex biochemical and physiological stress response leading to impairment&#xD;
      of pulmonary, immunological and metabolic functions.&#xD;
&#xD;
      The Transversus Abdominis Plane (TAP) block, is a regional anaesthesia technique used for&#xD;
      various surgeries through the lower to mid-abdominal wall.The addition of fentanyl to the&#xD;
      local anaesthetic in ultrasound-guided TAP block prolongs the analgesia, lowers postoperative&#xD;
      pain, and decreases the opioid consumption. Adding midazolam as a bupivacaine adjuvant for&#xD;
      TAP block reduces the 24-h morphine consumption extends the postoperative analgesia duration.&#xD;
      The aim of the work is to study the effect of the addition fentanyl and midazolam on the&#xD;
      onset, duration of the analgesic effect of Tap block intraoperative fentanyl consumption,&#xD;
      Time for first rescue Analgesia.&#xD;
&#xD;
      in patients undergoing simple unilateral abdominal surgeries.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Informed written consent will be obtained from study participants or their legally authorized&#xD;
      representative. This is a randomized controlled double blinded study; patients will be&#xD;
      enrolled in the study and will be randomized and equally divided into three groups:&#xD;
&#xD;
      Group A: (TAP block with 20 ml of bupivacaine 0.25% and 50 μ g of fentanyl) Group B: (TAP&#xD;
      block with 20 ml bupivacaine 0.25% and 50 μ g /kg midazolam) Group C: (TAP block with 20 ml&#xD;
      bupivacaine 0.25% only). Induction of general anaesthesia will be performed using a regimen&#xD;
      of IV 1 μ g/kg fentanyl and Propofol IV 2 mg /kg. Tracheal intubation will be facilitated&#xD;
      using 0.5 mg/kg IV of atracurium.&#xD;
&#xD;
      Maintenance of Anaesthesia:&#xD;
&#xD;
      Anaesthesia will be maintained with inhaled sevoflurane with MAC 2% in oxygen enriched air&#xD;
      (FiO2=0.5) and top up doses of Atracurium (0.1 mg/kg) IV will be administered every 30&#xD;
      minutes.&#xD;
&#xD;
      Ringer acetate will be infused to replace their fluid deficit, maintenance and losses, and&#xD;
      the patients will be mechanically ventilated using the appropriate setting that will keep the&#xD;
      end-tidal CO2 at 30-35mmHg.&#xD;
&#xD;
      One reading of mean arterial pressure (MAP) and heart rate (HR) will be taken 1 minute before&#xD;
      induction of general anaesthesia (a baseline reading), 1 minute before surgical incision and&#xD;
      at 15-minute intervals intra operatively.&#xD;
&#xD;
      Lack of inadequate intraoperative analgesia, as defined by an increase in pulse rate,&#xD;
      sweating, and tearing (PRST) score &gt;2 or an increase of mean arterial blood pressure (MAP)&#xD;
      &gt;20% of baseline (8) was treated by additional rescue IV fentanyl 1-2 mcg/kg IV bolus.&#xD;
&#xD;
      Hypotension will be treated with 0.9% normal saline and/or 5mg ephedrine in incremental doses&#xD;
      to maintain mean blood pressure above 70 mmHg.&#xD;
&#xD;
      The residual neuromuscular blockade will be reversed using neostigmine (0.05 mg/kg) and&#xD;
      atropine (0.02 mg/kg), and extubation will be performed after complete recovery of the airway&#xD;
      reflexes.&#xD;
&#xD;
      The patient will be transferred to the post-anaesthesia care unit (PACU) where the MAP and HR&#xD;
      will be recorded immediately upon arrival.&#xD;
&#xD;
      Side effects such as local anaesthetic toxicity, postoperative nausea and vomiting (PONV),&#xD;
      respiratory depression (respiratory rate &lt;10/minute) will be recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 10, 2020</start_date>
  <completion_date type="Anticipated">July 15, 2020</completion_date>
  <primary_completion_date type="Anticipated">July 10, 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>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Onset of the Analgesic effect of TAP block with different additives</measure>
    <time_frame>30 minutes</time_frame>
    <description>The patient will be asked to register a prick respectively on the upper extremity. Sensory change will then be assessed in the mid-clavicular line, starting above dermatome T4 moving caudally to dermatome L4.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dose of intra-Operative fentanyl consumption</measure>
    <time_frame>2 hours</time_frame>
    <description>Lack of inadequate intraoperative analgesia, as defined by an increase in pulse rate, sweating, and tearing (PRST) score &gt;2 or an increase of mean arterial blood pressure (MAP) &gt;20% of baseline was treated by additional rescue IV fentanyl 1-2 mcg/kg IV bolus.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Block related complications</measure>
    <time_frame>24 hours</time_frame>
    <description>haematoma, neurological complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of first analgesic request</measure>
    <time_frame>24 hours</time_frame>
    <description>visual analogue scale equals or more than 4</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of postoperative nausea and vomiting</measure>
    <time_frame>24 hours postoperative</time_frame>
    <description>will be assessed using by yes/ no scale</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>fentanyle</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>: patients will receive US guided unilateral Transversus abdominis plane block (25 ml bupivacaine 0.25% &amp; fentanyl).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Midazolam</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients will receive us guided unilateral Transversus abdominis plane block (25 ml bupivacaine 0.25% &amp; midazolam).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>patients will receive us guided unilateral Transversus abdominis plane block (25 ml bupivacaine 0.25%).</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ultrasound Guided Transversus Abdominis Plane Block</intervention_name>
    <description>The patient will lie in the supine position. The transducer will be placed in the axial plane on the mid-axillary. transversus abdominis muscle will be visualized. A skin wheel using 3 ml of lidocaine 1 % is made 2 to 3 cm medial to the medial aspect of the transducer and the 22 gauge is inserted in-plane pointing laterally. Then Injection of local anaesthetic mixure in the right plane.</description>
    <arm_group_label>Midazolam</arm_group_label>
    <arm_group_label>control</arm_group_label>
    <arm_group_label>fentanyle</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Physical status ASA I and ASA ll.&#xD;
&#xD;
          -  Age ≥ 18 and ≤ 65 Years.&#xD;
&#xD;
          -  Body mass index (BMI): ≥ 20 kg/m2 and ≤ 35 kg/m2.&#xD;
&#xD;
          -  Patients undergoing Abdominal Surgeries.&#xD;
&#xD;
          -  Patient is able to provide a written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known sensitivity to local anaesthetics.&#xD;
&#xD;
          -  Significant liver or renal insufficiency.&#xD;
&#xD;
          -  Contraindication to regional anaesthesia e.g. local - sepsis, pre-existing peripheral&#xD;
             neuropathies and coagulopathy.&#xD;
&#xD;
          -  Patient refusal.&#xD;
&#xD;
          -  Failed Block.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>yahia hammad, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yahia Hammad</last_name>
    <phone>+201114048081</phone>
    <email>yahya196cm@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Cairo university</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>yahia Hammad, M.D.</last_name>
      <phone>01224254012</phone>
      <email>bassantmohamed197@yahoo.com</email>
    </contact>
    <investigator>
      <last_name>Shereen Moustafa, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Yahia Hammad, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Nehra P, Oza V, Parmar V, Fumakiya P. Effect of Addition of Fentanyl and Clonidine to Local Anesthetic Solution in Peribulbar Block. J Pharmacol Pharmacother. 2017 Jan-Mar;8(1):3-7. doi: 10.4103/jpp.JPP_109_16.</citation>
    <PMID>28405129</PMID>
  </reference>
  <reference>
    <citation>Carney J, Finnerty O, Rauf J, Bergin D, Laffey JG, Mc Donnell JG. Studies on the spread of local anaesthetic solution in transversus abdominis plane blocks. Anaesthesia. 2011 Nov;66(11):1023-30. doi: 10.1111/j.1365-2044.2011.06855.x. Epub 2011 Aug 18.</citation>
    <PMID>21851346</PMID>
  </reference>
  <results_reference>
    <citation>Tsai HC, Yoshida T, Chuang TY, Yang SF, Chang CC, Yao HY, Tai YT, Lin JA, Chen KY. Transversus Abdominis Plane Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:8284363. doi: 10.1155/2017/8284363. Epub 2017 Oct 31.</citation>
    <PMID>29226150</PMID>
  </results_reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 10, 2020</last_update_submitted>
  <last_update_submitted_qc>June 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Bassant M. Abdelhamid</investigator_full_name>
    <investigator_title>associate professor</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>
  <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/NCT04426617
org study id: MS-258-2019
nct id: NCT04426617
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Pain triggers a complex biochemical and physiological stress response leading to impairment
      of pulmonary, immunological and metabolic functions.

      The Transversus Abdominis Plane (TAP) block, is a regional anaesthesia technique used for
      various surgeries through the lower to mid-abdominal wall.The addition of fentanyl to the
      local anaesthetic in ultrasound-guided TAP block prolongs the analgesia, lowers postoperative
      pain, and decreases the opioid consumption. Adding midazolam as a bupivacaine adjuvant for
      TAP block reduces the 24-h morphine consumption extends the postoperative analgesia duration.
      The aim of the work is to study the effect of the addition fentanyl and midazolam on the
      onset, duration of the analgesic effect of Tap block intraoperative fentanyl consumption,
      Time for first rescue Analgesia.

      in patients undergoing simple unilateral abdominal surgeries.
Informed written consent will be obtained from study participants or their legally authorized
      representative. This is a randomized controlled double blinded study; patients will be
      enrolled in the study and will be randomized and equally divided into three groups:

      Group A: (TAP block with 20 ml of bupivacaine 0.25% and 50 μ g of fentanyl) Group B: (TAP
      block with 20 ml bupivacaine 0.25% and 50 μ g /kg midazolam) Group C: (TAP block with 20 ml
      bupivacaine 0.25% only). Induction of general anaesthesia will be performed using a regimen
      of IV 1 μ g/kg fentanyl and Propofol IV 2 mg /kg. Tracheal intubation will be facilitated
      using 0.5 mg/kg IV of atracurium.

      Maintenance of Anaesthesia:

      Anaesthesia will be maintained with inhaled sevoflurane with MAC 2% in oxygen enriched air
      (FiO2=0.5) and top up doses of Atracurium (0.1 mg/kg) IV will be administered every 30
      minutes.

      Ringer acetate will be infused to replace their fluid deficit, maintenance and losses, and
      the patients will be mechanically ventilated using the appropriate setting that will keep the
      end-tidal CO2 at 30-35mmHg.

      One reading of mean arterial pressure (MAP) and heart rate (HR) will be taken 1 minute before
      induction of general anaesthesia (a baseline reading), 1 minute before surgical incision and
      at 15-minute intervals intra operatively.

      Lack of inadequate intraoperative analgesia, as defined by an increase in pulse rate,
      sweating, and tearing (PRST) score >2 or an increase of mean arterial blood pressure (MAP)
      >20% of baseline (8) was treated by additional rescue IV fentanyl 1-2 mcg/kg IV bolus.

      Hypotension will be treated with 0.9% normal saline and/or 5mg ephedrine in incremental doses
      to maintain mean blood pressure above 70 mmHg.

      The residual neuromuscular blockade will be reversed using neostigmine (0.05 mg/kg) and
      atropine (0.02 mg/kg), and extubation will be performed after complete recovery of the airway
      reflexes.

      The patient will be transferred to the post-anaesthesia care unit (PACU) where the MAP and HR
      will be recorded immediately upon arrival.

      Side effects such as local anaesthetic toxicity, postoperative nausea and vomiting (PONV),
      respiratory depression (respiratory rate <10/minute) will be recorded.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Onset of the Analgesic effect of TAP block with different additives
time frame: 30 minutes
description: The patient will be asked to register a prick respectively on the upper extremity. Sensory change will then be assessed in the mid-clavicular line, starting above dermatome T4 moving caudally to dermatome L4.
measure: Dose of intra-Operative fentanyl consumption
time frame: 2 hours
description: Lack of inadequate intraoperative analgesia, as defined by an increase in pulse rate, sweating, and tearing (PRST) score >2 or an increase of mean arterial blood pressure (MAP) >20% of baseline was treated by additional rescue IV fentanyl 1-2 mcg/kg IV bolus.
measure: Block related complications
time frame: 24 hours
description: haematoma, neurological complications
measure: Time of first analgesic request
time frame: 24 hours
description: visual analogue scale equals or more than 4
measure: Incidence of postoperative nausea and vomiting
time frame: 24 hours postoperative
description: will be assessed using by yes/ no scale
arm group label: fentanyle
arm group type: Experimental
description: : patients will receive US guided unilateral Transversus abdominis plane block (25 ml bupivacaine 0.25% & fentanyl).
arm group label: Midazolam
arm group type: Experimental
description: patients will receive us guided unilateral Transversus abdominis plane block (25 ml bupivacaine 0.25% & midazolam).
arm group label: control
arm group type: Placebo Comparator
description: patients will receive us guided unilateral Transversus abdominis plane block (25 ml bupivacaine 0.25%).
intervention type: Procedure
intervention name: Ultrasound Guided Transversus Abdominis Plane Block
description: The patient will lie in the supine position. The transducer will be placed in the axial plane on the mid-axillary. transversus abdominis muscle will be visualized. A skin wheel using 3 ml of lidocaine 1 % is made 2 to 3 cm medial to the medial aspect of the transducer and the 22 gauge is inserted in-plane pointing laterally. Then Injection of local anaesthetic mixure in the right plane.
arm group label: Midazolam
arm group label: control
arm group label: fentanyle
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: yahia hammad, M.D.
role: Principal Investigator
affiliation: Cairo University
last name: Yahia Hammad
phone: +201114048081
email: yahya196cm@hotmail.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: Egypt
citation: Nehra P, Oza V, Parmar V, Fumakiya P. Effect of Addition of Fentanyl and Clonidine to Local Anesthetic Solution in Peribulbar Block. J Pharmacol Pharmacother. 2017 Jan-Mar;8(1):3-7. doi: 10.4103/jpp.JPP_109_16.
PMID: 28405129
citation: Carney J, Finnerty O, Rauf J, Bergin D, Laffey JG, Mc Donnell JG. Studies on the spread of local anaesthetic solution in transversus abdominis plane blocks. Anaesthesia. 2011 Nov;66(11):1023-30. doi: 10.1111/j.1365-2044.2011.06855.x. Epub 2011 Aug 18.
PMID: 21851346
citation: Tsai HC, Yoshida T, Chuang TY, Yang SF, Chang CC, Yao HY, Tai YT, Lin JA, Chen KY. Transversus Abdominis Plane Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:8284363. doi: 10.1155/2017/8284363. Epub 2017 Oct 31.
PMID: 29226150
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Bassant M. Abdelhamid
investigator title: associate professor
mesh term: Pain, Postoperative
sharing ipd: No