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The Feasibility of Performing Erector Spinae (ESP) Nerve Block in Bariatric Patients; a Case Series Study

Primary Purpose

Nerve Pain

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Ultrasound Guided Erector Spinae Plane (ESP) Nerve Block
Bupivacaine Injection
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nerve Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age range 21 - 70.
  • ASA II: A patient with mild systemic disease-ASA III: A patient with severe systemic disease
  • Patients included are those immediately postoperative from bariatric surgery who have an NSR pain score >5

Exclusion Criteria:

  • Patients excluded are those who are ASA IV or greater, refuse nerve block intervention,
  • Diagnosis of any coagulopathy disorder,
  • Allergy to local anesthetics,
  • Have active infection over proposed injection sites.
  • Patients with ASA >III was excluded due to overall health concerns of poorly controlled chronic disease.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    ESP nerve block

    Standard of Care

    Arm Description

    Standard of care includes IV opioids, NSAIDs (commonly ketorolac), +/- acetaminophen. No regional anesthesia will be given to control patients.

    Outcomes

    Primary Outcome Measures

    Rate of reduction of opiod usage after ESP Block
    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.

    Secondary Outcome Measures

    Number of patients who experience an adverse events
    Pain scores (self reported) assessed by the NRS rating scale
    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

    Full Information

    First Posted
    July 13, 2020
    Last Updated
    June 4, 2021
    Sponsor
    Montefiore Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04477525
    Brief Title
    The Feasibility of Performing Erector Spinae (ESP) Nerve Block in Bariatric Patients; a Case Series Study
    Official Title
    The Feasibility of Performing Erector Spinae (ESP) Nerve Block in Bariatric Patients; a Case Series Stud
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    PI changed hospital center
    Study Start Date
    June 22, 2021 (Anticipated)
    Primary Completion Date
    June 2022 (Anticipated)
    Study Completion Date
    June 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Montefiore Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Nerve Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ESP nerve block
    Arm Type
    Experimental
    Arm Title
    Standard of Care
    Arm Type
    No Intervention
    Arm 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(s)
    Ultrasound Guided Erector Spinae Plane (ESP) Nerve Block
    Intervention 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.
    Intervention Type
    Drug
    Intervention Name(s)
    Bupivacaine Injection
    Intervention Description
    20 cc of 0.25% bupivacaine will be injected
    Primary Outcome Measure Information:
    Title
    Rate of reduction of opiod usage after ESP Block
    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.
    Time Frame
    24 hours
    Secondary Outcome Measure Information:
    Title
    Number of patients who experience an adverse events
    Time Frame
    Up to 3 days
    Title
    Pain scores (self reported) assessed by the NRS rating scale
    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
    Time Frame
    Every 30 min while in the post-anesthesia care unit (PACU); at 24 and 48 hours during hospital stay

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age range 21 - 70. ASA II: A patient with mild systemic disease-ASA III: A patient with severe systemic disease Patients included are those immediately postoperative from bariatric surgery who have an NSR pain score >5 Exclusion Criteria: Patients excluded are those who are ASA IV or greater, refuse nerve block intervention, Diagnosis of any coagulopathy disorder, Allergy to local anesthetics, Have active infection over proposed injection sites. Patients with ASA >III was excluded due to overall health concerns of poorly controlled chronic disease.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Farah Fadi
    Organizational Affiliation
    Montefiore Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    The Feasibility of Performing Erector Spinae (ESP) Nerve Block in Bariatric Patients; a Case Series Study

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