<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/NCT03798522</url>
  </required_header>
  <id_info>
    <org_study_id>N-42-2018</org_study_id>
    <nct_id>NCT03798522</nct_id>
  </id_info>
  <brief_title>Erector Spinae Plane Block Versus Opioid Based General Anesthesia During Laparoscopic Bariatric Surgery</brief_title>
  <official_title>Analgesic Efficacy of Erector Spinae Plane Block Versus Opioid Based General Anesthesia During Laparoscopic Bariatric Surgery; 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      bilateral continuous erector spinae plane blockade may represent a valuable alternatives to&#xD;
      thoracіc epidurals analgaesіa in treatment of thoracic neuropathic pain.&#xD;
&#xD;
      There were 3 cases reported in 2017 suggested that the erector spinae plane block provides&#xD;
      visceral abdominal analgesia in bariatric surgery and at end of the report they recommended&#xD;
      further clinical investigation. The investigators hypothesіzed that performing the erector&#xD;
      spinae plane (ESP) block at T7 would provide effective abdominal analgaesіa іn patients&#xD;
      undergone laparoscopic bariatric surgery. The investigators aimed to compare the analgesic&#xD;
      effect of erector spinae plane block and opioid based general anesthesia for laparoscopic&#xD;
      bariatric surgeries.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators hypothesized that, erector spinae plane block will provide good analgesia&#xD;
      for patients undergoing laparoscopic bariatric surgery with less complication compared to&#xD;
      opioid based general anesthesia. The visual analogue scale (VAS) will be explained clearly to&#xD;
      all participants before conduction of anesthesia. All the drugs will be calculated according&#xD;
      to the ideal body weight (IBW).A low-frequency (2-5 MHz) curved array ultrasound probe&#xD;
      (Mindray®, China) will be used. In the 1st group: bilateral ultrasound-guided erector spinae&#xD;
      plane block will be performed under complete aseptic conditions in the lateral position at T7&#xD;
      vertebrae and before induction of general anesthesia. An 8-cm echogenic 22-G block needle&#xD;
      will be inserted in-plane. A total of 20 ml of local anesthetic solution (20 ml bupivacaine&#xD;
      (Sunnypivacaine, Sunny pharmaceutical, Egypt) 0.25%) will then be injected into the erector&#xD;
      spinae plane. This procedure will be repeated on the contralateral side taking care not to&#xD;
      exceed the maximum recommended doses (2 mg/kg of IBW for bupivacaine). In the 2nd group: the&#xD;
      investigator will give intravenous nalbuphine in a dose of 2mg /kg according to ideal body&#xD;
      weight after induction of general anesthesia. All participants will be given 1 gram of&#xD;
      intravenous paracetamol (15 mg/Kg), together with 4 mg ondansetron 10 min prior to the end of&#xD;
      surgery for postoperative nausea and vomiting prophylaxis.&#xD;
&#xD;
      Intraoperatively, any increase in heart rate and/or arterial blood pressure 10 min after&#xD;
      intubation by more than 20% of baseline values in response to surgical stimulus or thereafter&#xD;
      throughout the whole operation will be managed by intravenous administration of fentanyl 0.5&#xD;
      µg/Kg. VAS score will be assessed 30 min after extubation and when the VAS score exceeded&#xD;
      4/10, rescue analgesia in the form of IV nalbuphine 5 mg will be administered. Another dose&#xD;
      of rescue analgesia can be given in the post anesthesia care unit (PACU) if the VAS still&#xD;
      more than 4 after 60 min of extubation. If still high, Ketorolac 60 mg will be given by&#xD;
      intravenous infusion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">September 30, 2019</completion_date>
  <primary_completion_date type="Actual">August 30, 2019</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>
    <intervention_model_description>erector spinae plane block group (ESPB)&#xD;
general anesthesia group (GA)</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The duration of analgesic effect in minutes</measure>
    <time_frame>defined as the time n minutes between finishing the block technique in ESPB group or after administration of nalbuphine in GA-group, and the request of first dose of postoperative analgesics) when VAS is more than 4 during the 1st 8 hours postoperatively</time_frame>
    <description>The duration of analgesic effect is indicated by the 1st analgesic requisite after measurement of VAS</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>mean arterial blood pressure changes</measure>
    <time_frame>intraoperative and post extubation in the 1st hour</time_frame>
    <description>mean arterial blood pressure will be assessed and measured in mmHg non invasively</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nalbuphine consumption</measure>
    <time_frame>total dose given post operatively up to 1 hour postoperatively</time_frame>
    <description>in mg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>visual analogue scale (VAS) for assessment of postoperative pain</measure>
    <time_frame>at 30 minutes, 45 minutes and 60 minutes, 4 hours and 8 hours after surgery</time_frame>
    <description>in numbers, normal scale ranges from 0 to 10 with 0 means no pain and 10 means worst pain imaginable. if VAS score exceeded 4/10; this will be considered insufficient analgesia and participant will be given rescue analgesia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Block failure rate</measure>
    <time_frame>in the first hour postoperatively</time_frame>
    <description>patient required more than two 5mg doses of nalbuphine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resumption of peristalsis</measure>
    <time_frame>postoperatively up to 48 hours postoperatively</time_frame>
    <description>in hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>incidence of adverse effects</measure>
    <time_frame>postoperative up to 48 hours</time_frame>
    <description>postoperative nausea and vomiting, urinary retention, hematoma formation, local anesthetic toxicity and need of postoperative ICU or mechanical ventilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of shoulder pain</measure>
    <time_frame>postoperativey up to 24 hours</time_frame>
    <description>percent</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>length of hospital stay</measure>
    <time_frame>postoperative up to 28 days postoperatively</time_frame>
    <description>in days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>heart rate</measure>
    <time_frame>intraoperatively and throughout one hour postextubation</time_frame>
    <description>heart rate in beat per minute will be measured</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Failure rate of the ESP block</measure>
    <time_frame>in the first hour postoperatively</time_frame>
    <description>the block will be considered a failed block if the patient required more than two 5mg doses of nalbuphine</description>
  </secondary_outcome>
  <other_outcome>
    <measure>demographic data</measure>
    <time_frame>during 30 minutes preoperatively</time_frame>
    <description>age, sex, ASA class, co-morbidities</description>
  </other_outcome>
  <other_outcome>
    <measure>duration of surgery</measure>
    <time_frame>from skin incision up to skin closure</time_frame>
    <description>in minutes</description>
  </other_outcome>
  <other_outcome>
    <measure>weight</measure>
    <time_frame>during 30 minutes preoperatively</time_frame>
    <description>kilograms</description>
  </other_outcome>
  <other_outcome>
    <measure>height</measure>
    <time_frame>during 30 minutes preoperatively</time_frame>
    <description>meter</description>
  </other_outcome>
  <other_outcome>
    <measure>body mass index (BMI)</measure>
    <time_frame>uring 30 minutes preoperatively</time_frame>
    <description>weight in kilograms divided by square height in meter</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Bariatric Surgery Candidate</condition>
  <condition>Morbid Obesity</condition>
  <condition>Visceral Pain</condition>
  <arm_group>
    <arm_group_label>erector spinae plane block group (ESPB) n=14</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Bilateral ultrasound guided erector spinae plane block will be performed in the lateral position at T7 vertebrae and before induction of GA. 20 ml of local anesthetic solution (20 ml bupivacaine (Sunnypivacaine, Sunny pharmaceutical, Egypt) 0.25%) will be injected in-plane into the ESP. This procedure will be repeated on the other side taking care not to exceed the maximum recommended doses (2 mg/kg of IBW for bupivacaine) and then GA will be conducted .</description>
  </arm_group>
  <arm_group>
    <arm_group_label>general anesthesia group (GA) n= 14</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>these patients will receive iv nalbuphine in dose of 2mg /kg according to ideal body weight after induction of GA</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>bilateral ultrasound guided erector spinae plane block</intervention_name>
    <description>ESPB on both sides at T7 before GA</description>
    <arm_group_label>erector spinae plane block group (ESPB) n=14</arm_group_label>
    <other_name>ESPB</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nalbuphine</intervention_name>
    <description>in nalbuphine for analgesia after GA</description>
    <arm_group_label>general anesthesia group (GA) n= 14</arm_group_label>
    <other_name>GA</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient age &gt;18 &lt;60&#xD;
&#xD;
          -  Obese patients 40˂ Body mass index(BMI) ˂50&#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>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hany Mohammed El-Hadi Shoukat Mohammed</name>
      <address>
        <city>Giza</city>
        <zip>12211</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>December 27, 2018</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>January 11, 2020</last_update_submitted>
  <last_update_submitted_qc>January 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Hany Mohammed El-Hadi Shoukat Mohammed</investigator_full_name>
    <investigator_title>lecturer of anesthesia, pain management and surgical ICU</investigator_title>
  </responsible_party>
  <keyword>ultrasound guided regional blocks</keyword>
  <keyword>laparoscopic surgery</keyword>
  <keyword>erector spinae plane block</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity, Morbid</mesh_term>
    <mesh_term>Visceral Pain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nalbuphine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>yes</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>9 months</ipd_time_frame>
    <ipd_access_criteria>Researchgate.gov</ipd_access_criteria>
  </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/NCT03798522
org study id: N-42-2018
nct id: NCT03798522
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
bilateral continuous erector spinae plane blockade may represent a valuable alternatives to
      thoracіc epidurals analgaesіa in treatment of thoracic neuropathic pain.

      There were 3 cases reported in 2017 suggested that the erector spinae plane block provides
      visceral abdominal analgesia in bariatric surgery and at end of the report they recommended
      further clinical investigation. The investigators hypothesіzed that performing the erector
      spinae plane (ESP) block at T7 would provide effective abdominal analgaesіa іn patients
      undergone laparoscopic bariatric surgery. The investigators aimed to compare the analgesic
      effect of erector spinae plane block and opioid based general anesthesia for laparoscopic
      bariatric surgeries.
The investigators hypothesized that, erector spinae plane block will provide good analgesia
      for patients undergoing laparoscopic bariatric surgery with less complication compared to
      opioid based general anesthesia. The visual analogue scale (VAS) will be explained clearly to
      all participants before conduction of anesthesia. All the drugs will be calculated according
      to the ideal body weight (IBW).A low-frequency (2-5 MHz) curved array ultrasound probe
      (Mindray®, China) will be used. In the 1st group: bilateral ultrasound-guided erector spinae
      plane block will be performed under complete aseptic conditions in the lateral position at T7
      vertebrae and before induction of general anesthesia. An 8-cm echogenic 22-G block needle
      will be inserted in-plane. A total of 20 ml of local anesthetic solution (20 ml bupivacaine
      (Sunnypivacaine, Sunny pharmaceutical, Egypt) 0.25%) will then be injected into the erector
      spinae plane. This procedure will be repeated on the contralateral side taking care not to
      exceed the maximum recommended doses (2 mg/kg of IBW for bupivacaine). In the 2nd group: the
      investigator will give intravenous nalbuphine in a dose of 2mg /kg according to ideal body
      weight after induction of general anesthesia. All participants will be given 1 gram of
      intravenous paracetamol (15 mg/Kg), together with 4 mg ondansetron 10 min prior to the end of
      surgery for postoperative nausea and vomiting prophylaxis.

      Intraoperatively, any increase in heart rate and/or arterial blood pressure 10 min after
      intubation by more than 20% of baseline values in response to surgical stimulus or thereafter
      throughout the whole operation will be managed by intravenous administration of fentanyl 0.5
      µg/Kg. VAS score will be assessed 30 min after extubation and when the VAS score exceeded
      4/10, rescue analgesia in the form of IV nalbuphine 5 mg will be administered. Another dose
      of rescue analgesia can be given in the post anesthesia care unit (PACU) if the VAS still
      more than 4 after 60 min of extubation. If still high, Ketorolac 60 mg will be given by
      intravenous infusion.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: erector spinae plane block group (ESPB)
general anesthesia group (GA)
primary purpose: Prevention
masking: Single (Participant)
measure: The duration of analgesic effect in minutes
time frame: defined as the time n minutes between finishing the block technique in ESPB group or after administration of nalbuphine in GA-group, and the request of first dose of postoperative analgesics) when VAS is more than 4 during the 1st 8 hours postoperatively
description: The duration of analgesic effect is indicated by the 1st analgesic requisite after measurement of VAS
measure: mean arterial blood pressure changes
time frame: intraoperative and post extubation in the 1st hour
description: mean arterial blood pressure will be assessed and measured in mmHg non invasively
measure: Nalbuphine consumption
time frame: total dose given post operatively up to 1 hour postoperatively
description: in mg
measure: visual analogue scale (VAS) for assessment of postoperative pain
time frame: at 30 minutes, 45 minutes and 60 minutes, 4 hours and 8 hours after surgery
description: in numbers, normal scale ranges from 0 to 10 with 0 means no pain and 10 means worst pain imaginable. if VAS score exceeded 4/10; this will be considered insufficient analgesia and participant will be given rescue analgesia
measure: Block failure rate
time frame: in the first hour postoperatively
description: patient required more than two 5mg doses of nalbuphine
measure: Resumption of peristalsis
time frame: postoperatively up to 48 hours postoperatively
description: in hours
measure: incidence of adverse effects
time frame: postoperative up to 48 hours
description: postoperative nausea and vomiting, urinary retention, hematoma formation, local anesthetic toxicity and need of postoperative ICU or mechanical ventilation
measure: Incidence of shoulder pain
time frame: postoperativey up to 24 hours
description: percent
measure: length of hospital stay
time frame: postoperative up to 28 days postoperatively
description: in days
measure: heart rate
time frame: intraoperatively and throughout one hour postextubation
description: heart rate in beat per minute will be measured
measure: Failure rate of the ESP block
time frame: in the first hour postoperatively
description: the block will be considered a failed block if the patient required more than two 5mg doses of nalbuphine
measure: demographic data
time frame: during 30 minutes preoperatively
description: age, sex, ASA class, co-morbidities
measure: duration of surgery
time frame: from skin incision up to skin closure
description: in minutes
measure: weight
time frame: during 30 minutes preoperatively
description: kilograms
measure: height
time frame: during 30 minutes preoperatively
description: meter
measure: body mass index (BMI)
time frame: uring 30 minutes preoperatively
description: weight in kilograms divided by square height in meter
arm group label: erector spinae plane block group (ESPB) n=14
arm group type: Experimental
description: Bilateral ultrasound guided erector spinae plane block will be performed in the lateral position at T7 vertebrae and before induction of GA. 20 ml of local anesthetic solution (20 ml bupivacaine (Sunnypivacaine, Sunny pharmaceutical, Egypt) 0.25%) will be injected in-plane into the ESP. This procedure will be repeated on the other side taking care not to exceed the maximum recommended doses (2 mg/kg of IBW for bupivacaine) and then GA will be conducted .
arm group label: general anesthesia group (GA) n= 14
arm group type: Active Comparator
description: these patients will receive iv nalbuphine in dose of 2mg /kg according to ideal body weight after induction of GA
intervention type: Procedure
intervention name: bilateral ultrasound guided erector spinae plane block
description: ESPB on both sides at T7 before GA
arm group label: erector spinae plane block group (ESPB) n=14
other name: ESPB
intervention type: Drug
intervention name: Nalbuphine
description: in nalbuphine for analgesia after GA
arm group label: general anesthesia group (GA) n= 14
other name: GA
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Hany Mohammed El-Hadi Shoukat Mohammed
investigator title: lecturer of anesthesia, pain management and surgical ICU
mesh term: Obesity, Morbid
mesh term: Visceral Pain
mesh term: Nalbuphine
sharing ipd: Yes
ipd description: yes
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: 9 months
ipd access criteria: Researchgate.gov