<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/NCT04403711</url>
  </required_header>
  <id_info>
    <org_study_id>TAP-dexmedetomidine</org_study_id>
    <nct_id>NCT04403711</nct_id>
  </id_info>
  <brief_title>Dexmedetomidine in TAP Block for Inguinal Hernia Repair</brief_title>
  <acronym>TAP-dex</acronym>
  <official_title>The Effect of Adding Dexmedetomidine to the Local Anesthetic Solution for Ultrasonography-guided TAP Block in Inguinal Hernia Repair</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aretaieion University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aretaieion University Hospital</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This prospective double-blind randomized study will aim at evaluating the short- and&#xD;
      long-term postoperative analgesic efficacy of the ultrasound-guided transversus abdominis&#xD;
      plane (TAP) block with a combination of local anesthetic and dexmedetomidine in inguinal&#xD;
      hernia repair under general anesthesia&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Inguinal hernia repair is one of the most commonly performed surgical procedures worldwide,&#xD;
      especially in the day-case setting. It can be accompanied by moderate to severe postoperative&#xD;
      pain, which can delay return to normal daily activities or lead to the development of chronic&#xD;
      pain. Chronic pain after hernia repair has a reported prevalence ranging between 0% and 43%&#xD;
      with both nociceptive and neuropathic features. The transversus abdominis plane (TAP) block&#xD;
      is an effective regional anesthetic technique to reduce postoperative pain intensity, time to&#xD;
      first rescue anesthetic administration and opioid demand after upper and lower abdominal&#xD;
      surgery. Dexmedetomidine is a selective α2-adrenergic agonist with analgesic properties that&#xD;
      has been shown to prolong local anesthetic action when used as an adjunct to local anesthetic&#xD;
      solutions in neuraxial anesthesia. The aim of this prospective, double-blind placebo&#xD;
      controlled randomized study will be to evaluate the analgesic efficacy of ultrasound-guided&#xD;
      TAP block where local anesthetic is supplemented by dexmedetomidine in patients undergoing&#xD;
      unilateral elective inguinal hernia repair with the Lichtenstein technique under general&#xD;
      anesthesia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 1, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>pain score 3 hours postoperatively</measure>
    <time_frame>3 hours after surgery</time_frame>
    <description>pain score by the use of Numeric Rating Scale (NRS) 3 hours postoperatively, ranging from 0 to 10, where 0 means &quot;no pain&quot; and 10 means &quot;worst pain imaginable&quot;</description>
  </primary_outcome>
  <primary_outcome>
    <measure>pain score 6 hours postoperatively</measure>
    <time_frame>6 hours after surgery</time_frame>
    <description>pain score by the use of Numeric Rating Scale (NRS) 6 hours postoperatively, ranging from 0 to 10, where 0 means &quot;no pain&quot; and 10 means &quot;worst pain imaginable&quot;</description>
  </primary_outcome>
  <primary_outcome>
    <measure>pain score 24 hours postoperatively</measure>
    <time_frame>24 hours after surgery</time_frame>
    <description>pain score by the use of Numeric Rating Scale (NRS) 24 hours postoperatively, ranging from 0 to 10, where 0 means &quot;no pain&quot; and 10 means &quot;worst pain imaginable&quot;</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>incidence of chronic pain</measure>
    <time_frame>6 months after surgery</time_frame>
    <description>occurrence of chronic pain at the site of the operation, with the use of the NRS, at rest and during movement</description>
  </secondary_outcome>
  <other_outcome>
    <measure>morphine consumption</measure>
    <time_frame>24 hours postoperatively</time_frame>
    <description>morphine consumption through patient-controlled analgesia device for 24 hours postoperatively</description>
  </other_outcome>
  <other_outcome>
    <measure>satisfaction from postoperative analgesia</measure>
    <time_frame>24 hours postoperatively</time_frame>
    <description>satisfaction from postoperative analgesia on a four-point Likert scale with 1 marked as minimal satisfaction and 4 as maximal satisfaction</description>
  </other_outcome>
  <other_outcome>
    <measure>transversus abdominis plane-related complications</measure>
    <time_frame>48 hours postoperatively</time_frame>
    <description>transversus abdominis plane-related complications at the site of the local anesthetic injection</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Inguinal Hernia</condition>
  <condition>Analgesia</condition>
  <condition>Pain, Acute</condition>
  <condition>Pain, Chronic</condition>
  <condition>Pain, Neuropathic</condition>
  <arm_group>
    <arm_group_label>local anesthetic and dexmedetomidine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ultrasound-guided transversus abdominis plane block with 25 mL ropivacaine 0.5% and 2 mL dexmedetomidine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>local anesthetic and placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>ultrasound-guided transversus abdominis plane block with 25 mL ropivacaine 0.5% and 2 mL normal saline</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>local anesthetic and dexmedetomidine</intervention_name>
    <description>in patients allocated to the dexmedetomidine group, ultrasound-guided transversus abdominis plane block will be performed with the combination of local anesthetic and dexmedetomidine</description>
    <arm_group_label>local anesthetic and dexmedetomidine</arm_group_label>
    <other_name>medication used in regional anesthetic technique</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>local anesthetic and placebo</intervention_name>
    <description>in patients allocated to the dexmedetomidine group, ultrasound-guided transversus abdominis plane block will be performed with the combination of local anesthetic and normal saline</description>
    <arm_group_label>local anesthetic and placebo</arm_group_label>
    <other_name>medication used in regional anesthetic technique</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) patients I-III undergoing inguinal hernia&#xD;
             repair with a mesh&#xD;
&#xD;
          -  open hernia repair&#xD;
&#xD;
          -  elective surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  inability to consent to the study due to language barriers or cognitive dysfunction -&#xD;
&#xD;
          -  bilateral inguinal hernia repair,&#xD;
&#xD;
          -  body mass index over 40 kg m-2,&#xD;
&#xD;
          -  skin infection at the puncture site&#xD;
&#xD;
          -  contraindication to paracetamol or non-steroidal anti-inflammatory drug (NSAIDs)&#xD;
             administration&#xD;
&#xD;
          -  known previous hepatic or renal impairment as assessed by the patients' history and&#xD;
             routine biochemical markers&#xD;
&#xD;
          -  coagulation abnormalities&#xD;
&#xD;
          -  history of gastroesophageal reflux and preoperative use of opioids or NSAIDs for&#xD;
             chronic pain conditions&#xD;
&#xD;
          -  reoperation of recurrent inguinal hernia after previous mesh repair&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kassiani Theodoraki, PhD, DESA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aretaieion University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aretaieion University Hospital</name>
      <address>
        <city>Athens</city>
        <state>Αττική</state>
        <zip>11528</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kassiani Theodoraki, PhD, DESA</last_name>
      <phone>+306974634162</phone>
      <email>ktheodoraki@hotmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Ioannis Koutalas, MD</last_name>
    </contact_backup>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <reference>
    <citation>Bay-Nielsen M, Perkins FM, Kehlet H; Danish Hernia Database. Pain and functional impairment 1 year after inguinal herniorrhaphy: a nationwide questionnaire study. Ann Surg. 2001 Jan;233(1):1-7. doi: 10.1097/00000658-200101000-00001.</citation>
    <PMID>11141218</PMID>
  </reference>
  <reference>
    <citation>Alfieri S, Amid PK, Campanelli G, Izard G, Kehlet H, Wijsmuller AR, Di Miceli D, Doglietto GB. International guidelines for prevention and management of post-operative chronic pain following inguinal hernia surgery. Hernia. 2011 Jun;15(3):239-49. doi: 10.1007/s10029-011-0798-9. Epub 2011 Mar 2.</citation>
    <PMID>21365287</PMID>
  </reference>
  <reference>
    <citation>Petersen PL, Mathiesen O, Torup H, Dahl JB. The transversus abdominis plane block: a valuable option for postoperative analgesia? A topical review. Acta Anaesthesiol Scand. 2010 May;54(5):529-35. doi: 10.1111/j.1399-6576.2010.02215.x. Epub 2010 Feb 17.</citation>
    <PMID>20175754</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>Mikkelsen T, Werner MU, Lassen B, Kehlet H. Pain and sensory dysfunction 6 to 12 months after inguinal herniotomy. Anesth Analg. 2004 Jul;99(1):146-151. doi: 10.1213/01.ANE.0000115147.14626.C5.</citation>
    <PMID>15281521</PMID>
  </reference>
  <reference>
    <citation>Goudarzi TH, Kamali A, Yazdi B, Broujerdi GN. Addition of dexmedetomidine, tramadol and neostigmine to lidocaine 1.5% increasing the duration of postoperative analgesia in the lower abdominal pain surgery among children: A double-blinded randomized clinical study. Med Gas Res. 2019 Jul-Sep;9(3):110-114. doi: 10.4103/2045-9912.266984.</citation>
    <PMID>31552872</PMID>
  </reference>
  <reference>
    <citation>Theodoraki K, Papacharalampous P, Tsaroucha A, Vezakis A, Argyra E. The effect of transversus abdominis plane block on acute and chronic pain after inguinal hernia repair. A randomized controlled trial. Int J Surg. 2019 Mar;63:63-70. doi: 10.1016/j.ijsu.2019.02.007. Epub 2019 Feb 12.</citation>
    <PMID>30769214</PMID>
  </reference>
  <reference>
    <citation>Chen Q, Liu X, Zhong X, Yang B. Addition of dexmedetomidine or fentanyl to ropivacaine for transversus abdominis plane block: evaluation of effect on postoperative pain and quality of recovery in gynecological surgery. J Pain Res. 2018 Nov 16;11:2897-2903. doi: 10.2147/JPR.S178516. eCollection 2018.</citation>
    <PMID>30532583</PMID>
  </reference>
  <reference>
    <citation>Ramya Parameswari A, Udayakumar P. Comparison of Efficacy of Bupivacaine with Dexmedetomidine Versus Bupivacaine Alone for Transversus Abdominis Plane Block for Post-operative Analgesia in Patients Undergoing Elective Caesarean Section. J Obstet Gynaecol India. 2018 Apr;68(2):98-103. doi: 10.1007/s13224-017-0990-7. Epub 2017 Apr 26.</citation>
    <PMID>29662278</PMID>
  </reference>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>July 10, 2022</last_update_submitted>
  <last_update_submitted_qc>July 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 12, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aretaieion University Hospital</investigator_affiliation>
    <investigator_full_name>Dr Kassiani Theodoraki</investigator_full_name>
    <investigator_title>Professor of Anesthesiology</investigator_title>
  </responsible_party>
  <keyword>transversus abdominis plane block</keyword>
  <keyword>dexmedetomidine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neuralgia</mesh_term>
    <mesh_term>Hernia</mesh_term>
    <mesh_term>Hernia, Inguinal</mesh_term>
    <mesh_term>Acute Pain</mesh_term>
    <mesh_term>Chronic Pain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexmedetomidine</mesh_term>
    <mesh_term>Anesthetics</mesh_term>
    <mesh_term>Anesthetics, Local</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/NCT04403711
org study id: TAP-dexmedetomidine
nct id: NCT04403711
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This prospective double-blind randomized study will aim at evaluating the short- and
      long-term postoperative analgesic efficacy of the ultrasound-guided transversus abdominis
      plane (TAP) block with a combination of local anesthetic and dexmedetomidine in inguinal
      hernia repair under general anesthesia
Inguinal hernia repair is one of the most commonly performed surgical procedures worldwide,
      especially in the day-case setting. It can be accompanied by moderate to severe postoperative
      pain, which can delay return to normal daily activities or lead to the development of chronic
      pain. Chronic pain after hernia repair has a reported prevalence ranging between 0% and 43%
      with both nociceptive and neuropathic features. The transversus abdominis plane (TAP) block
      is an effective regional anesthetic technique to reduce postoperative pain intensity, time to
      first rescue anesthetic administration and opioid demand after upper and lower abdominal
      surgery. Dexmedetomidine is a selective α2-adrenergic agonist with analgesic properties that
      has been shown to prolong local anesthetic action when used as an adjunct to local anesthetic
      solutions in neuraxial anesthesia. The aim of this prospective, double-blind placebo
      controlled randomized study will be to evaluate the analgesic efficacy of ultrasound-guided
      TAP block where local anesthetic is supplemented by dexmedetomidine in patients undergoing
      unilateral elective inguinal hernia repair with the Lichtenstein technique under general
      anesthesia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: pain score 3 hours postoperatively
time frame: 3 hours after surgery
description: pain score by the use of Numeric Rating Scale (NRS) 3 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
measure: pain score 6 hours postoperatively
time frame: 6 hours after surgery
description: pain score by the use of Numeric Rating Scale (NRS) 6 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
measure: pain score 24 hours postoperatively
time frame: 24 hours after surgery
description: pain score by the use of Numeric Rating Scale (NRS) 24 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
measure: incidence of chronic pain
time frame: 6 months after surgery
description: occurrence of chronic pain at the site of the operation, with the use of the NRS, at rest and during movement
measure: morphine consumption
time frame: 24 hours postoperatively
description: morphine consumption through patient-controlled analgesia device for 24 hours postoperatively
measure: satisfaction from postoperative analgesia
time frame: 24 hours postoperatively
description: satisfaction from postoperative analgesia on a four-point Likert scale with 1 marked as minimal satisfaction and 4 as maximal satisfaction
measure: transversus abdominis plane-related complications
time frame: 48 hours postoperatively
description: transversus abdominis plane-related complications at the site of the local anesthetic injection
arm group label: local anesthetic and dexmedetomidine
arm group type: Active Comparator
description: ultrasound-guided transversus abdominis plane block with 25 mL ropivacaine 0.5% and 2 mL dexmedetomidine
arm group label: local anesthetic and placebo
arm group type: Placebo Comparator
description: ultrasound-guided transversus abdominis plane block with 25 mL ropivacaine 0.5% and 2 mL normal saline
intervention type: Other
intervention name: local anesthetic and dexmedetomidine
description: in patients allocated to the dexmedetomidine group, ultrasound-guided transversus abdominis plane block will be performed with the combination of local anesthetic and dexmedetomidine
arm group label: local anesthetic and dexmedetomidine
other name: medication used in regional anesthetic technique
intervention type: Other
intervention name: local anesthetic and placebo
description: in patients allocated to the dexmedetomidine group, ultrasound-guided transversus abdominis plane block will be performed with the combination of local anesthetic and normal saline
arm group label: local anesthetic and placebo
other name: medication used in regional anesthetic technique
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Kassiani Theodoraki, PhD, DESA
role: Principal Investigator
affiliation: Aretaieion University Hospital
facility: 
status: Recruiting
contact: 
contact backup: 
country: Greece
citation: Bay-Nielsen M, Perkins FM, Kehlet H; Danish Hernia Database. Pain and functional impairment 1 year after inguinal herniorrhaphy: a nationwide questionnaire study. Ann Surg. 2001 Jan;233(1):1-7. doi: 10.1097/00000658-200101000-00001.
PMID: 11141218
citation: Alfieri S, Amid PK, Campanelli G, Izard G, Kehlet H, Wijsmuller AR, Di Miceli D, Doglietto GB. International guidelines for prevention and management of post-operative chronic pain following inguinal hernia surgery. Hernia. 2011 Jun;15(3):239-49. doi: 10.1007/s10029-011-0798-9. Epub 2011 Mar 2.
PMID: 21365287
citation: Petersen PL, Mathiesen O, Torup H, Dahl JB. The transversus abdominis plane block: a valuable option for postoperative analgesia? A topical review. Acta Anaesthesiol Scand. 2010 May;54(5):529-35. doi: 10.1111/j.1399-6576.2010.02215.x. Epub 2010 Feb 17.
PMID: 20175754
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: Mikkelsen T, Werner MU, Lassen B, Kehlet H. Pain and sensory dysfunction 6 to 12 months after inguinal herniotomy. Anesth Analg. 2004 Jul;99(1):146-151. doi: 10.1213/01.ANE.0000115147.14626.C5.
PMID: 15281521
citation: Goudarzi TH, Kamali A, Yazdi B, Broujerdi GN. Addition of dexmedetomidine, tramadol and neostigmine to lidocaine 1.5% increasing the duration of postoperative analgesia in the lower abdominal pain surgery among children: A double-blinded randomized clinical study. Med Gas Res. 2019 Jul-Sep;9(3):110-114. doi: 10.4103/2045-9912.266984.
PMID: 31552872
citation: Theodoraki K, Papacharalampous P, Tsaroucha A, Vezakis A, Argyra E. The effect of transversus abdominis plane block on acute and chronic pain after inguinal hernia repair. A randomized controlled trial. Int J Surg. 2019 Mar;63:63-70. doi: 10.1016/j.ijsu.2019.02.007. Epub 2019 Feb 12.
PMID: 30769214
citation: Chen Q, Liu X, Zhong X, Yang B. Addition of dexmedetomidine or fentanyl to ropivacaine for transversus abdominis plane block: evaluation of effect on postoperative pain and quality of recovery in gynecological surgery. J Pain Res. 2018 Nov 16;11:2897-2903. doi: 10.2147/JPR.S178516. eCollection 2018.
PMID: 30532583
citation: Ramya Parameswari A, Udayakumar P. Comparison of Efficacy of Bupivacaine with Dexmedetomidine Versus Bupivacaine Alone for Transversus Abdominis Plane Block for Post-operative Analgesia in Patients Undergoing Elective Caesarean Section. J Obstet Gynaecol India. 2018 Apr;68(2):98-103. doi: 10.1007/s13224-017-0990-7. Epub 2017 Apr 26.
PMID: 29662278
responsible party type: Principal Investigator
investigator affiliation: Aretaieion University Hospital
investigator full name: Dr Kassiani Theodoraki
investigator title: Professor of Anesthesiology
mesh term: Neuralgia
mesh term: Hernia
mesh term: Hernia, Inguinal
mesh term: Acute Pain
mesh term: Chronic Pain
mesh term: Dexmedetomidine
mesh term: Anesthetics
mesh term: Anesthetics, Local
sharing ipd: No