<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/NCT04477525</url>
  </required_header>
  <id_info>
    <org_study_id>2020-11082</org_study_id>
    <nct_id>NCT04477525</nct_id>
  </id_info>
  <brief_title>The Feasibility of Performing Erector Spinae (ESP) Nerve Block in Bariatric Patients; a Case Series Study</brief_title>
  <official_title>The Feasibility of Performing Erector Spinae (ESP) Nerve Block in Bariatric Patients; a Case Series Stud</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Montefiore Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Montefiore Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a pilot study to assess the effectiveness of erector spinae (ESP) nerve blocks&#xD;
      for postoperative pain control following bariatric surgery. Currently, there are mainly case&#xD;
      series/pilot studies describing the use of ESP nerve blocks for postoperative pain control in&#xD;
      abdominal procedures; of these only one uses this treatment modality for bariatric&#xD;
      procedures. The population undergoing bariatric surgery poses specific challenges to&#xD;
      postoperative pain management. They often have comorbid obstructive sleep apnea, which puts&#xD;
      them at greater risk for ventilatory depression when treated with parenteral opioids. This&#xD;
      risk can be reduced with regional techniques. The ESP nerve blocks provide visceral and&#xD;
      somatic pain coverage as opposed to the more commonplace transversus abdominis plane nerve&#xD;
      block which only provides somatic coverage. This means that the ESP nerve blocks will cover&#xD;
      incisional pain as well as the discomfort associated with the pain from the procedure itself.&#xD;
      This study intends to build on current knowledge by proving that the use of ESP in the&#xD;
      post-operative are providing a significant reduction in pain scores as well as reducing the&#xD;
      need for parenteral opioids. Thus, decreasing the risk of postoperative ventilatory&#xD;
      complications.&#xD;
&#xD;
      In preparation for this study, three pilot studies were reviewed. The studies assessed the&#xD;
      usefulness of ESP nerve blocks on patients undergoing abdominal surgery. Single-shot&#xD;
      bilateral ESP blocks were performed in the first two studies. One of the studies, patients&#xD;
      undergoing ventral hernia repair and the other for patients undergoing bariatric surgery. The&#xD;
      third pilot study used bilateral ESP blocks followed by a continuous infusion on one patient&#xD;
      undergoing an open prostatectomy with bladder reconstruction. All the ESP blocks were placed&#xD;
      preoperatively at the T7 transverse process. In the studies using a single shot technique&#xD;
      20-30 ml of ropivacaine 0.5% was used. For the continuous ESP catheter an initial bolus of&#xD;
      bupivacaine 0.25% 10 mls followed by continuous infusion rate of 6 ml/hr bilaterally. All&#xD;
      showed a significant reduction numerical rating scale (NRS) as a primary outcome. The&#xD;
      secondary outcome of reduced 24-hour parenteral opioid consumption was also achieved by all&#xD;
      three studies.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    PI changed hospital center&#xD;
  </why_stopped>
  <start_date type="Anticipated">June 22, 2021</start_date>
  <completion_date type="Anticipated">June 2022</completion_date>
  <primary_completion_date type="Anticipated">June 2022</primary_completion_date>
  <phase>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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of reduction of opiod usage after ESP Block</measure>
    <time_frame>24 hours</time_frame>
    <description>This study will evaluate the role of ESP blocks in reducing 24-hour opioid requirements after bariatric surgery, specifically looking into 30% or more reduction in opioid usage ( morphine equivalence) in the 24 hours.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients who experience an adverse events</measure>
    <time_frame>Up to 3 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain scores (self reported) assessed by the NRS rating scale</measure>
    <time_frame>Every 30 min while in the post-anesthesia care unit (PACU); at 24 and 48 hours during hospital stay</time_frame>
    <description>Pain scores will be collected every 30 mins in the PACU and at 24 and 48 hours during the hospital stay. NRS pain scale=0 no pain to 10 Worst pain imaginable</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Nerve Pain</condition>
  <arm_group>
    <arm_group_label>ESP nerve block</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard of care includes IV opioids, NSAIDs (commonly ketorolac), +/- acetaminophen. No regional anesthesia will be given to control patients.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ultrasound Guided Erector Spinae Plane (ESP) Nerve Block</intervention_name>
    <description>The planned intervention is a bilateral erector spinae nerve block for patients undergoing bariatric surgery. This intervention will be performed in the PACU for patients with an NRS pain score &gt;5. All eligible candidates who have consented for this study will be present in the PACU, have all standard ASA monitoring placed. The patient will then be placed in a sitting position. The patient will then be prepped with chlorhexidine in the thoracic region and draped in a sterile fashion. The ultrasound will be brought in over the patient and the T7 Transverse Processes (TP) will be identified. An echogenic needle will be placed under direct ultrasound guidance on the TP. Then, 20 cc of 0.25% bupivacaine will be injected.</description>
    <arm_group_label>ESP nerve block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine Injection</intervention_name>
    <description>20 cc of 0.25% bupivacaine will be injected</description>
    <arm_group_label>ESP nerve block</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age range 21 - 70.&#xD;
&#xD;
          -  ASA II: A patient with mild systemic disease-ASA III: A patient with severe systemic&#xD;
             disease&#xD;
&#xD;
          -  Patients included are those immediately postoperative from bariatric surgery who have&#xD;
             an NSR pain score &gt;5&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients excluded are those who are ASA IV or greater, refuse nerve block&#xD;
             intervention,&#xD;
&#xD;
          -  Diagnosis of any coagulopathy disorder,&#xD;
&#xD;
          -  Allergy to local anesthetics,&#xD;
&#xD;
          -  Have active infection over proposed injection sites.&#xD;
&#xD;
          -  Patients with ASA &gt;III was excluded due to overall health concerns of poorly&#xD;
             controlled chronic disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Farah Fadi</last_name>
    <role>Principal Investigator</role>
    <affiliation>Montefiore Medical Center</affiliation>
  </overall_official>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>June 4, 2021</last_update_submitted>
  <last_update_submitted_qc>June 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neuralgia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupivacaine</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/NCT04477525
org study id: 2020-11082
nct id: NCT04477525
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This study is a pilot study to assess the effectiveness of erector spinae (ESP) nerve blocks
      for postoperative pain control following bariatric surgery. Currently, there are mainly case
      series/pilot studies describing the use of ESP nerve blocks for postoperative pain control in
      abdominal procedures; of these only one uses this treatment modality for bariatric
      procedures. The population undergoing bariatric surgery poses specific challenges to
      postoperative pain management. They often have comorbid obstructive sleep apnea, which puts
      them at greater risk for ventilatory depression when treated with parenteral opioids. This
      risk can be reduced with regional techniques. The ESP nerve blocks provide visceral and
      somatic pain coverage as opposed to the more commonplace transversus abdominis plane nerve
      block which only provides somatic coverage. This means that the ESP nerve blocks will cover
      incisional pain as well as the discomfort associated with the pain from the procedure itself.
      This study intends to build on current knowledge by proving that the use of ESP in the
      post-operative are providing a significant reduction in pain scores as well as reducing the
      need for parenteral opioids. Thus, decreasing the risk of postoperative ventilatory
      complications.

      In preparation for this study, three pilot studies were reviewed. The studies assessed the
      usefulness of ESP nerve blocks on patients undergoing abdominal surgery. Single-shot
      bilateral ESP blocks were performed in the first two studies. One of the studies, patients
      undergoing ventral hernia repair and the other for patients undergoing bariatric surgery. The
      third pilot study used bilateral ESP blocks followed by a continuous infusion on one patient
      undergoing an open prostatectomy with bladder reconstruction. All the ESP blocks were placed
      preoperatively at the T7 transverse process. In the studies using a single shot technique
      20-30 ml of ropivacaine 0.5% was used. For the continuous ESP catheter an initial bolus of
      bupivacaine 0.25% 10 mls followed by continuous infusion rate of 6 ml/hr bilaterally. All
      showed a significant reduction numerical rating scale (NRS) as a primary outcome. The
      secondary outcome of reduced 24-hour parenteral opioid consumption was also achieved by all
      three studies.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Rate of reduction of opiod usage after ESP Block
time frame: 24 hours
description: This study will evaluate the role of ESP blocks in reducing 24-hour opioid requirements after bariatric surgery, specifically looking into 30% or more reduction in opioid usage ( morphine equivalence) in the 24 hours.
measure: Number of patients who experience an adverse events
time frame: Up to 3 days
measure: Pain scores (self reported) assessed by the NRS rating scale
time frame: Every 30 min while in the post-anesthesia care unit (PACU); at 24 and 48 hours during hospital stay
description: Pain scores will be collected every 30 mins in the PACU and at 24 and 48 hours during the hospital stay. NRS pain scale=0 no pain to 10 Worst pain imaginable
arm group label: ESP nerve block
arm group type: Experimental
arm group label: Standard of Care
arm group type: No Intervention
description: Standard of care includes IV opioids, NSAIDs (commonly ketorolac), +/- acetaminophen. No regional anesthesia will be given to control patients.
intervention type: Procedure
intervention name: Ultrasound Guided Erector Spinae Plane (ESP) Nerve Block
description: The planned intervention is a bilateral erector spinae nerve block for patients undergoing bariatric surgery. This intervention will be performed in the PACU for patients with an NRS pain score >5. All eligible candidates who have consented for this study will be present in the PACU, have all standard ASA monitoring placed. The patient will then be placed in a sitting position. The patient will then be prepped with chlorhexidine in the thoracic region and draped in a sterile fashion. The ultrasound will be brought in over the patient and the T7 Transverse Processes (TP) will be identified. An echogenic needle will be placed under direct ultrasound guidance on the TP. Then, 20 cc of 0.25% bupivacaine will be injected.
arm group label: ESP nerve block
intervention type: Drug
intervention name: Bupivacaine Injection
description: 20 cc of 0.25% bupivacaine will be injected
arm group label: ESP nerve block
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Farah Fadi
role: Principal Investigator
affiliation: Montefiore Medical Center
responsible party type: Sponsor
mesh term: Neuralgia
mesh term: Bupivacaine
sharing ipd: No