<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/NCT04417179</url>
  </required_header>
  <id_info>
    <org_study_id>MD-250-2020</org_study_id>
    <nct_id>NCT04417179</nct_id>
  </id_info>
  <brief_title>Erector Spinae Block Versus Transversus Abdominis Plane Block In Laparoscopic Bariatric Surgery</brief_title>
  <official_title>The Feasibility and Efficacy of Erector Spinae Block Versus Transversus Abdominis Plane Block In Laparoscopic Bariatric Surgery</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>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>
      The purpose of this study to compare erector spinae block to transversus abdominis plane&#xD;
      block in bariatric surgeries regarding analgesic efficacy and postoperative oxygenation and&#xD;
      respiratory complications&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The erector spinae plane (ESP) block is an interfascial block proposed to provide analgesia&#xD;
      for chronic pain and perioperative period. it can provide both visceral and somatic abdominal&#xD;
      analgesia if the injection were performed at a lower thoracic level. ESP block is effective,&#xD;
      easy to perform, and can be performed in a short time. Therefore, bilateral ESP block may&#xD;
      have comparable or improved analgesic effect in upper and lower abdominal surgical procedures&#xD;
      when compared to other suitable plane blocks.&#xD;
&#xD;
      Transversus abdominis plane (TAP) block technique is to reduce postoperative pain and is a&#xD;
      part of current analgesic regimen for many abdominal surgeries . Moreover, it was found that&#xD;
      posterior TAP block appears to produce more prolonged analgesia than the lateral TAP block.&#xD;
      Ultrasound guided TAP block is a feasible, minimally invasive technique . It reduces the&#xD;
      postoperative requirement of opioid analgesics, decreases the incidence and severity of&#xD;
      postoperative nausea and vomiting, improves patient satisfaction, and allows early readiness&#xD;
      for discharge postoperatively.&#xD;
&#xD;
      Both blocks is effective in reducing postoperative complication and need of analgesia , To&#xD;
      our knowledge there is no comparative study between the two blocks to this population .&#xD;
&#xD;
      the investigators aim to compare the perioperative analgesic effect between TAP block and ES&#xD;
      block in bariatric .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 20, 2020</start_date>
  <completion_date type="Actual">February 20, 2022</completion_date>
  <primary_completion_date type="Actual">February 1, 2022</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>efficacy of block</measure>
    <time_frame>first 24 hours postoperative</time_frame>
    <description>The analgesic efficacy of erector spinae block versus TAP block assessed by visual analogue score(range from 1 denoted the least pain to 10 as the worst pain) in 24hr in laparoscopic bariatric surgery.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>failure rate</measure>
    <time_frame>first hour postoperatively</time_frame>
    <description>Failure rate in both groups</description>
  </secondary_outcome>
  <other_outcome>
    <measure>feasibility of block</measure>
    <time_frame>preoperative</time_frame>
    <description>Time taken to perform a successful block</description>
  </other_outcome>
  <other_outcome>
    <measure>ambulation</measure>
    <time_frame>24 hour</time_frame>
    <description>Time to ambulate in both groups</description>
  </other_outcome>
  <other_outcome>
    <measure>arterial oxygen tension to fraction of inspired oxygen ratio</measure>
    <time_frame>12, 24 hours postoperative</time_frame>
    <description>p/f ratio after first 12 , 24 hours postoperatively in both groups</description>
  </other_outcome>
  <other_outcome>
    <measure>pulmonary complications</measure>
    <time_frame>12,24 hours postoperative</time_frame>
    <description>Incidence of postoperative pulmonary complication ( chest x-ray at 12, 24 hr postoperative )</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Erector Spinae Block</condition>
  <condition>Bariatric Surgery Candidate</condition>
  <arm_group>
    <arm_group_label>TAP block group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>the TAP block will be given by a high frequency linear ultrasound transducer of Siemens acuson x300 3-5MHz ultrasound .&#xD;
a blunted tip , 20-gauge, short bevel needle (Pajunk Sonoplex, Geisingen, Germany) will be used under direct ultrasound visualization, . After confirming the correct placement of the needle and the negative aspiration probe anaesthetic substance will be injected along the subcostal line in the transversus abdominis plane 20 ml 0.25% bupivacaine(10) , and the dissection of the plane was observed. The block will be performed bilaterally.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ESP group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>the Erector Spinae block will be given by a high-frequency linear ultrasound transducer of Siemens acuson x300 3-5MHz ultrasound .A blunted tip , 20-gauge, short bevel needle (Pajunk Sonoplex, Geisingen, Germany) will be used under strict aseptic precautions until the tip is deep to erector spinae muscle, The block will be performed bilaterally by injecting 40 mL of 0.25% bupivacaine (20 mL into each side) into the fascial plane between the deep surface of the Erector Spinae muscle and the transverse processes of the lumbar vertebrae laterally</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>transversus abdominis block</intervention_name>
    <description>transversus abdominis block</description>
    <arm_group_label>TAP block group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Erector spinae block</intervention_name>
    <description>Erector spinae block</description>
    <arm_group_label>ESP group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine 0.25% Injectable Solution</intervention_name>
    <description>Local Anesthetic used in both blocks</description>
    <arm_group_label>ESP group</arm_group_label>
    <arm_group_label>TAP block group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Siemens Acuson x300 3-5MHz Ultrasound</intervention_name>
    <description>Ultrasound used to aid in the blocks</description>
    <arm_group_label>ESP group</arm_group_label>
    <arm_group_label>TAP block group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient age &gt;18 &lt;60&#xD;
&#xD;
          -  Obese patients ; Body mass index(BMI) 40-50 kg/m2&#xD;
&#xD;
          -  Both sexes&#xD;
&#xD;
          -  American Society of Anesthesiologists(ASA) physical status classes II and III&#xD;
&#xD;
          -  Patients scheduled for laparoscopic bariatric surgery i.e. sleeve gastrectomy and/or&#xD;
             Roux-en-Y gastric bypass (RYGB)surgeries&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal of regional block&#xD;
&#xD;
          -  Patients with neurological, psychological disorders or those lacking cooperation&#xD;
&#xD;
          -  Patients scheduled for concomitant laparoscopic cholecystectomy or paraumbilical&#xD;
             hernia repair or those with history of previous bariatric surgery or obstructive sleep&#xD;
             apnea&#xD;
&#xD;
          -  Patients with anatomic abnormalities at site of injection, skin lesions or wounds at&#xD;
             site of proposed needle insertion.&#xD;
&#xD;
          -  Patients with bleeding disorders defined as (INR &gt;2) and/ or (platelet count&#xD;
             &lt;100,000/µL)&#xD;
&#xD;
          -  Patients with hepatic disease e.g. liver cell failure or hepatic malignancy or hepatic&#xD;
             enlargement.&#xD;
&#xD;
          -  Patients who are allergic to amide local anesthetics.&#xD;
&#xD;
          -  Cases converted to open surgery will also be excluded from the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Faculty of Medicine</name>
      <address>
        <city>Cairo</city>
        <zip>11562</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Tulgar S, Selvi O, Kapakli MS. Erector Spinae Plane Block for Different Laparoscopic Abdominal Surgeries: Case Series. Case Rep Anesthesiol. 2018 Feb 18;2018:3947281. doi: 10.1155/2018/3947281. eCollection 2018.</citation>
    <PMID>29670771</PMID>
  </reference>
  <reference>
    <citation>Abdallah FW, Laffey JG, Halpern SH, Brull R. Duration of analgesic effectiveness after the posterior and lateral transversus abdominis plane block techniques for transverse lower abdominal incisions: a meta-analysis. Br J Anaesth. 2013 Nov;111(5):721-35. doi: 10.1093/bja/aet214. Epub 2013 Jun 27.</citation>
    <PMID>23811424</PMID>
  </reference>
  <reference>
    <citation>Mittal T, Dey A, Siddhartha R, Nali A, Sharma B, Malik V. Efficacy of ultrasound-guided transversus abdominis plane (TAP) block for postoperative analgesia in laparoscopic gastric sleeve resection: a randomized single blinded case control study. Surg Endosc. 2018 Dec;32(12):4985-4989. doi: 10.1007/s00464-018-6261-6. Epub 2018 Jun 4.</citation>
    <PMID>29869078</PMID>
  </reference>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>May 31, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>March 17, 2022</last_update_submitted>
  <last_update_submitted_qc>March 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>mohamed abdelghany ali</investigator_full_name>
    <investigator_title>Anesthesia lecturer</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04417179
org study id: MD-250-2020
nct id: NCT04417179
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study to compare erector spinae block to transversus abdominis plane
      block in bariatric surgeries regarding analgesic efficacy and postoperative oxygenation and
      respiratory complications
The erector spinae plane (ESP) block is an interfascial block proposed to provide analgesia
      for chronic pain and perioperative period. it can provide both visceral and somatic abdominal
      analgesia if the injection were performed at a lower thoracic level. ESP block is effective,
      easy to perform, and can be performed in a short time. Therefore, bilateral ESP block may
      have comparable or improved analgesic effect in upper and lower abdominal surgical procedures
      when compared to other suitable plane blocks.

      Transversus abdominis plane (TAP) block technique is to reduce postoperative pain and is a
      part of current analgesic regimen for many abdominal surgeries . Moreover, it was found that
      posterior TAP block appears to produce more prolonged analgesia than the lateral TAP block.
      Ultrasound guided TAP block is a feasible, minimally invasive technique . It reduces the
      postoperative requirement of opioid analgesics, decreases the incidence and severity of
      postoperative nausea and vomiting, improves patient satisfaction, and allows early readiness
      for discharge postoperatively.

      Both blocks is effective in reducing postoperative complication and need of analgesia , To
      our knowledge there is no comparative study between the two blocks to this population .

      the investigators aim to compare the perioperative analgesic effect between TAP block and ES
      block in bariatric .
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Outcomes Assessor)
measure: efficacy of block
time frame: first 24 hours postoperative
description: The analgesic efficacy of erector spinae block versus TAP block assessed by visual analogue score(range from 1 denoted the least pain to 10 as the worst pain) in 24hr in laparoscopic bariatric surgery.
measure: failure rate
time frame: first hour postoperatively
description: Failure rate in both groups
measure: feasibility of block
time frame: preoperative
description: Time taken to perform a successful block
measure: ambulation
time frame: 24 hour
description: Time to ambulate in both groups
measure: arterial oxygen tension to fraction of inspired oxygen ratio
time frame: 12, 24 hours postoperative
description: p/f ratio after first 12 , 24 hours postoperatively in both groups
measure: pulmonary complications
time frame: 12,24 hours postoperative
description: Incidence of postoperative pulmonary complication ( chest x-ray at 12, 24 hr postoperative )
arm group label: TAP block group
arm group type: Experimental
description: the TAP block will be given by a high frequency linear ultrasound transducer of Siemens acuson x300 3-5MHz ultrasound .
a blunted tip , 20-gauge, short bevel needle (Pajunk Sonoplex, Geisingen, Germany) will be used under direct ultrasound visualization, . After confirming the correct placement of the needle and the negative aspiration probe anaesthetic substance will be injected along the subcostal line in the transversus abdominis plane 20 ml 0.25% bupivacaine(10) , and the dissection of the plane was observed. The block will be performed bilaterally.
arm group label: ESP group
arm group type: Experimental
description: the Erector Spinae block will be given by a high-frequency linear ultrasound transducer of Siemens acuson x300 3-5MHz ultrasound .A blunted tip , 20-gauge, short bevel needle (Pajunk Sonoplex, Geisingen, Germany) will be used under strict aseptic precautions until the tip is deep to erector spinae muscle, The block will be performed bilaterally by injecting 40 mL of 0.25% bupivacaine (20 mL into each side) into the fascial plane between the deep surface of the Erector Spinae muscle and the transverse processes of the lumbar vertebrae laterally
intervention type: Procedure
intervention name: transversus abdominis block
description: transversus abdominis block
arm group label: TAP block group
intervention type: Procedure
intervention name: Erector spinae block
description: Erector spinae block
arm group label: ESP group
intervention type: Drug
intervention name: Bupivacaine 0.25% Injectable Solution
description: Local Anesthetic used in both blocks
arm group label: ESP group
arm group label: TAP block group
intervention type: Device
intervention name: Siemens Acuson x300 3-5MHz Ultrasound
description: Ultrasound used to aid in the blocks
arm group label: ESP group
arm group label: TAP block group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
facility: 
country: Egypt
citation: Tulgar S, Selvi O, Kapakli MS. Erector Spinae Plane Block for Different Laparoscopic Abdominal Surgeries: Case Series. Case Rep Anesthesiol. 2018 Feb 18;2018:3947281. doi: 10.1155/2018/3947281. eCollection 2018.
PMID: 29670771
citation: Abdallah FW, Laffey JG, Halpern SH, Brull R. Duration of analgesic effectiveness after the posterior and lateral transversus abdominis plane block techniques for transverse lower abdominal incisions: a meta-analysis. Br J Anaesth. 2013 Nov;111(5):721-35. doi: 10.1093/bja/aet214. Epub 2013 Jun 27.
PMID: 23811424
citation: Mittal T, Dey A, Siddhartha R, Nali A, Sharma B, Malik V. Efficacy of ultrasound-guided transversus abdominis plane (TAP) block for postoperative analgesia in laparoscopic gastric sleeve resection: a randomized single blinded case control study. Surg Endosc. 2018 Dec;32(12):4985-4989. doi: 10.1007/s00464-018-6261-6. Epub 2018 Jun 4.
PMID: 29869078
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: mohamed abdelghany ali
investigator title: Anesthesia lecturer
mesh term: Bupivacaine
sharing ipd: Undecided