<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/NCT03778671</url>
  </required_header>
  <id_info>
    <org_study_id>17300222</org_study_id>
    <nct_id>NCT03778671</nct_id>
  </id_info>
  <brief_title>Dexmedetomidine Versus Fentanyl Added to Levobupivacaine for Transversus Abdominis Plane (TAP) Block</brief_title>
  <official_title>Dexmedetomidine Versus Fentanyl Added to Levobupivacaine for Transversus Abdominis Plane (TAP) Block in Elderly Patients Undergoing Lower Abdominal Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut 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>
      The perioperative management of pain following lower abdominal surgery can pose a challenge&#xD;
      to anesthesia providers. Conventional practice has involved the use of opioids as well as&#xD;
      neuraxial analgesic techniques. Unfortunately, these therapies are not without potential&#xD;
      risks and side effects. These include nausea, vomiting, pruritus, urinary retention,&#xD;
      constipation, respiratory depression, and sedation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      One method used in this multimodal approach is the transversus abdominis plane block. This&#xD;
      block, as first described by Rafi. in 2001, provides analgesia to the anterolateral abdominal&#xD;
      wall. In 2007, McDonnell et al. further studied this technique in patients undergoing&#xD;
      large-bowel resection. He discovered a reduction in postoperative pain and morphine&#xD;
      consumption in the first 24 hours postoperatively, resulting in fewer opioid mediated side&#xD;
      effects. In this same year, Hebbard et al. described the use of ultrasound guidance to&#xD;
      provide real-time imaging of the muscle layers and needle placement to improve transversus&#xD;
      abdominis plane block accuracy. In 2008, Hebbard. described the subcostal approach of&#xD;
      transversus abdominis plane block, to target the nerves of the upper abdomen. Transversus&#xD;
      abdominis plane blocks continue to be studied and developed as an effective method for&#xD;
      providing analgesia for numerous types of transverses abdominis plane block duration is&#xD;
      limited to effect of administered local anesthetics.The use of an infusion catheter to&#xD;
      administer local anesthetics is an option to prolong the block's duration. Recently, adjuvant&#xD;
      medications were added to local anesthetics to prolong the effect of transverses abdominis&#xD;
      plane block .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">December 1, 2019</completion_date>
  <primary_completion_date type="Actual">November 1, 2019</primary_completion_date>
  <phase>Phase 1/Phase 2</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, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>first analgesic request</measure>
    <time_frame>24 hours</time_frame>
    <description>first time to call for analgesia</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Transversus Abdominis Block</condition>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive Levobupivacaine 5%</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group D</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive Levobupivacaine 5% + 1 µg/kg dexmedetomedine .</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group F</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive Levobupivacaine 5% + 1µg/kg fentanyl</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Levobupivacaine</intervention_name>
    <description>Patients will receive Levobupivacaine 5%</description>
    <arm_group_label>Group B</arm_group_label>
    <other_name>Levobupivacaine hydrate</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine Injection [Precedex]</intervention_name>
    <description>Patients will receive Levobupivacaine 5% + 1 µg/kg dexmedetomedine</description>
    <arm_group_label>Group D</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>fentanyl</intervention_name>
    <description>Patients will receive Levobupivacaine 5% + 1 µg/kg fentanyl</description>
    <arm_group_label>Group F</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA physical status II-III,&#xD;
&#xD;
          -  scheduled for uncomplicated elective paraumbilical hernia repair.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient refusal to participate in the study&#xD;
&#xD;
          2. Patients with coagulopathy or under anticoagulation therapy.&#xD;
&#xD;
          3. Infection near the site of needle insertion.&#xD;
&#xD;
          4. Body mass index &gt; 40kg/m2&#xD;
&#xD;
          5. Patients with any neurological or neuromuscular disorder or history of seizures.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Assiut governorate</name>
      <address>
        <city>Assiut</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Elvir-Lazo OL, White PF. The role of multimodal analgesia in pain management after ambulatory surgery. Curr Opin Anaesthesiol. 2010 Dec;23(6):697-703. doi: 10.1097/ACO.0b013e32833fad0a.</citation>
    <PMID>20847690</PMID>
  </reference>
  <reference>
    <citation>White PF, Kehlet H. Improving postoperative pain management: what are the unresolved issues? Anesthesiology. 2010 Jan;112(1):220-5. doi: 10.1097/ALN.0b013e3181c6316e. No abstract available.</citation>
    <PMID>20010418</PMID>
  </reference>
  <reference>
    <citation>Sharma P, Chand T, Saxena A, Bansal R, Mittal A, Shrivastava U. Evaluation of postoperative analgesic efficacy of transversus abdominis plane block after abdominal surgery: A comparative study. J Nat Sci Biol Med. 2013 Jan;4(1):177-80. doi: 10.4103/0976-9668.107286.</citation>
    <PMID>23633858</PMID>
  </reference>
  <reference>
    <citation>McDonnell JG, O'Donnell B, Curley G, Heffernan A, Power C, Laffey JG. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial. Anesth Analg. 2007 Jan;104(1):193-7. doi: 10.1213/01.ane.0000250223.49963.0f. Erratum In: Anesth Analg. 2007 May;104(5):1108.</citation>
    <PMID>17179269</PMID>
  </reference>
  <reference>
    <citation>Aditianingsih D, Mochtar CA, Chandra S, Sukmono RB, Soamole IW. Comparison of Three-Quadrant Transversus Abdominis Plane Block and Continuous Epidural Block for Postoperative Analgesia After Transperitoneal Laparoscopic Nephrectomy. Anesth Pain Med. 2018 Sep 3;8(5):e80024. doi: 10.5812/aapm.80024. eCollection 2018 Oct.</citation>
    <PMID>30533391</PMID>
  </reference>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>December 16, 2018</study_first_submitted>
  <study_first_submitted_qc>December 16, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>October 8, 2021</last_update_submitted>
  <last_update_submitted_qc>October 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Ghada Mohammed AboelFadl</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <keyword>transversus abdominis plane block</keyword>
  <keyword>Dexmedetomidine</keyword>
  <keyword>Fentanyl</keyword>
  <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>Levobupivacaine</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/NCT03778671
org study id: 17300222
nct id: NCT03778671
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The perioperative management of pain following lower abdominal surgery can pose a challenge
      to anesthesia providers. Conventional practice has involved the use of opioids as well as
      neuraxial analgesic techniques. Unfortunately, these therapies are not without potential
      risks and side effects. These include nausea, vomiting, pruritus, urinary retention,
      constipation, respiratory depression, and sedation.
One method used in this multimodal approach is the transversus abdominis plane block. This
      block, as first described by Rafi. in 2001, provides analgesia to the anterolateral abdominal
      wall. In 2007, McDonnell et al. further studied this technique in patients undergoing
      large-bowel resection. He discovered a reduction in postoperative pain and morphine
      consumption in the first 24 hours postoperatively, resulting in fewer opioid mediated side
      effects. In this same year, Hebbard et al. described the use of ultrasound guidance to
      provide real-time imaging of the muscle layers and needle placement to improve transversus
      abdominis plane block accuracy. In 2008, Hebbard. described the subcostal approach of
      transversus abdominis plane block, to target the nerves of the upper abdomen. Transversus
      abdominis plane blocks continue to be studied and developed as an effective method for
      providing analgesia for numerous types of transverses abdominis plane block duration is
      limited to effect of administered local anesthetics.The use of an infusion catheter to
      administer local anesthetics is an option to prolong the block's duration. Recently, adjuvant
      medications were added to local anesthetics to prolong the effect of transverses abdominis
      plane block .
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: first analgesic request
time frame: 24 hours
description: first time to call for analgesia
arm group label: Group B
arm group type: Experimental
description: Patients will receive Levobupivacaine 5%
arm group label: Group D
arm group type: Active Comparator
description: Patients will receive Levobupivacaine 5% + 1 µg/kg dexmedetomedine .
arm group label: Group F
arm group type: Active Comparator
description: Patients will receive Levobupivacaine 5% + 1µg/kg fentanyl
intervention type: Drug
intervention name: Levobupivacaine
description: Patients will receive Levobupivacaine 5%
arm group label: Group B
other name: Levobupivacaine hydrate
intervention type: Drug
intervention name: Dexmedetomidine Injection [Precedex]
description: Patients will receive Levobupivacaine 5% + 1 µg/kg dexmedetomedine
arm group label: Group D
intervention type: Drug
intervention name: fentanyl
description: Patients will receive Levobupivacaine 5% + 1 µg/kg fentanyl
arm group label: Group F
criteria: 
gender: All
minimum age: 65 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: Egypt
citation: Elvir-Lazo OL, White PF. The role of multimodal analgesia in pain management after ambulatory surgery. Curr Opin Anaesthesiol. 2010 Dec;23(6):697-703. doi: 10.1097/ACO.0b013e32833fad0a.
PMID: 20847690
citation: White PF, Kehlet H. Improving postoperative pain management: what are the unresolved issues? Anesthesiology. 2010 Jan;112(1):220-5. doi: 10.1097/ALN.0b013e3181c6316e. No abstract available.
PMID: 20010418
citation: Sharma P, Chand T, Saxena A, Bansal R, Mittal A, Shrivastava U. Evaluation of postoperative analgesic efficacy of transversus abdominis plane block after abdominal surgery: A comparative study. J Nat Sci Biol Med. 2013 Jan;4(1):177-80. doi: 10.4103/0976-9668.107286.
PMID: 23633858
citation: McDonnell JG, O'Donnell B, Curley G, Heffernan A, Power C, Laffey JG. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial. Anesth Analg. 2007 Jan;104(1):193-7. doi: 10.1213/01.ane.0000250223.49963.0f. Erratum In: Anesth Analg. 2007 May;104(5):1108.
PMID: 17179269
citation: Aditianingsih D, Mochtar CA, Chandra S, Sukmono RB, Soamole IW. Comparison of Three-Quadrant Transversus Abdominis Plane Block and Continuous Epidural Block for Postoperative Analgesia After Transperitoneal Laparoscopic Nephrectomy. Anesth Pain Med. 2018 Sep 3;8(5):e80024. doi: 10.5812/aapm.80024. eCollection 2018 Oct.
PMID: 30533391
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Ghada Mohammed AboelFadl
investigator title: principal investigator
mesh term: Fentanyl
mesh term: Dexmedetomidine
mesh term: Levobupivacaine
sharing ipd: No