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Are Superficial Parasternal Intercostal Plane (SPIP) Blocks With Bupivacaine and With or Without Transversus Abdominis Plane Block (TAP) Helpful for Post-operative Pain After Coronary Artery Bypass Grafting?

Primary Purpose

Post-operative Pain Management

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SPIP and TAP Block
SPIP Block
Sponsored by
Wayne State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Post-operative Pain Management focused on measuring coronary artery bypass grafting, superficial parasternal intercostal plane block , transversus abdominis plane block, opioid consumption

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- Patients undergoing primary coronary artery bypass grafting

Exclusion Criteria:

  • Patients with significant genetic or acquired clotting/bleeding disorders (hemophilia, DIC, etc.)
  • Patients with significant platelet dysfunction
  • Infection at site for regional anesthesia
  • Allergy to local anesthetics
  • Severe aortic stenosis
  • Severe mitral stenosis
  • Sepsis

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    SPIP Block

    SPIP Block with TAP Block

    Arm Description

    50 Patients-Post-operatively patients will receive bilateral SPIP blocks by injecting 20 mL of 0.25% bupivacaine (on each side) between the pectoralis major and external intercostal muscle aponeurosis at 2 cm lateral to the right and left of the sternal edge, corresponding to the fifth rib.

    50 Patients-Post-operatively patients will receive bilateral SPIP blocks by injecting 20 mL of 0.25% bupivacaine (on each side) between the pectoralis major and external intercostal muscle aponeurosis at 2 cm lateral to the right and left of the sternal edge, corresponding to the fifth rib. This group of patients will also receive unilateral TAP block by injecting 20 mL of 0.25% bupivacaine in the plane between the internal oblique and transversus abdominis muscles.

    Outcomes

    Primary Outcome Measures

    Post-operative total opioid consumption (oral morphine equivalents)
    Total Opioid consumption 24 hours post surgery oral moral morphine equivalents
    Visual analog scale (VAS) pain scores
    Pain Scores measured via a Visual Analog Scale (0-10, Higher scores mean worse outcome)
    Visual analog scale (VAS) pain scores
    Pain Scores measured via a Visual Analog Scale (0-10, Higher scores mean worse outcome)
    Visual analog scale (VAS) pain scores
    Pain Scores measured via a Visual Analog Scale (0-10, Higher scores mean worse outcome)
    Length of hospital stay (LOS)
    The days spent in the hospital from surgery to discharge

    Secondary Outcome Measures

    Incidence of post-operation nausea and vomiting (PONV)
    The percentage of the patients who had post-operative nausea and vomiting (PONV) within 24 hours of surgery
    Acetaminophen consumption
    Total acetaminophen consumption in mg 24 hr after surgery
    NSAID (ketorolac) consumption
    Total NSAID consumption in mg
    Length of ICU stay
    Length of stay in Intensive Care Unit from surgery to discharge from Intensive Care Unit
    Time to extubation
    Time it took for patient to be extubated

    Full Information

    First Posted
    October 12, 2021
    Last Updated
    October 12, 2021
    Sponsor
    Wayne State University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05090735
    Brief Title
    Are Superficial Parasternal Intercostal Plane (SPIP) Blocks With Bupivacaine and With or Without Transversus Abdominis Plane Block (TAP) Helpful for Post-operative Pain After Coronary Artery Bypass Grafting?
    Official Title
    Are Superficial Parasternal Intercostal Plane (SPIP) Blocks With Transversus Abdominis Plane (TAP) Block More Helpful Than SPIP Blocks Alone in Managing Post-operative Pain in Coronary Artery Bypass Grafting (CABG)?
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2021 (Anticipated)
    Primary Completion Date
    November 2022 (Anticipated)
    Study Completion Date
    November 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Wayne State University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to determine whether superficial parasternal intercostal plane (SPIP) block alone or with transverses abdominis plane (TAP) block can improve post-operative pain in patients undergoing cardiothoracic surgery, specifically, coronary artery bypass grafting (CABG).
    Detailed Description
    Postoperative pain management remains an important clinical challenge in cardiothoracic surgery. Inadequate postoperative pain control can have adverse pathophysiologic consequences, including increased myocardial oxygen demand, hypoventilation, suboptimal clearance of pulmonary secretions, acute respiratory failure, and decreased mobility, with associated increased risks for formation of clots in a blood vessels (thromboembolism). These adverse events may result in greater perioperative morbidity and mortality. Despite several multimodal approaches to postoperative pain control, optimal pain management after cardiothoracic procedures remains an issue. Regional anesthesia is used to block sensation in a specific part of body during and after surgery. It offers numerous advantages over conventional general anesthesia, including faster recovery time, fewer side effects, no need for an airway device during surgery, and a dramatic reduction in post-surgical pain and reduction in opioid use following surgery. The use of local anesthetic peripheral nerve blocks for surgical anesthesia and postoperative pain management has increased significantly with the advent of ultrasound-guided techniques. Ultrasound has revolutionized regional anesthesia by allowing real-time visualization of anatomical structures, needle advancement and local anesthetic (LA) spread. This has led not only to refinement of existing techniques, but also the introduction of new ones. In particular, ultrasound has been critical in the development of fascial plane blocks, in which local anesthetic (LA) is injected into a tissue plane rather than directly around nerves. These blocks are believed to work via passive spread of LA to nerves traveling within that tissue plane, or to adjacent tissue compartments containing nerves. Although research into these techniques is still at an early stage, the available evidence indicates that they are effective in reducing opioid requirements and improving the pain experience in a wide range of clinical settings. They are best employed as part of multimodal analgesia with other systemic analgesics, rather than as sole anesthetic techniques. Catheters may be beneficial in situations where moderate-severe pain is expected for >12 hours, although the optimal dosing regimen requires further investigation. In this study the investigators will focus on the superficial parasternal-intercostal plane (SPIP) block and the transverses abdomens plane (TAP) block. The investigators will compare the SPIP block administered alone and with a TAP block; the investigators will measure the visual analog scale (VAS) pain scores in the first 24 hours after surgery, total post-operative opioid consumption (oral morphine equivalents), total acetaminophen and ketorolac consumption, post-operative nausea and vomiting (PONV), length of the ICU stay, time to extubation, and length of hospital stay to determine if one technique is superior to the other.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post-operative Pain Management
    Keywords
    coronary artery bypass grafting, superficial parasternal intercostal plane block , transversus abdominis plane block, opioid consumption

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    SPIP Block
    Arm Type
    Active Comparator
    Arm Description
    50 Patients-Post-operatively patients will receive bilateral SPIP blocks by injecting 20 mL of 0.25% bupivacaine (on each side) between the pectoralis major and external intercostal muscle aponeurosis at 2 cm lateral to the right and left of the sternal edge, corresponding to the fifth rib.
    Arm Title
    SPIP Block with TAP Block
    Arm Type
    Active Comparator
    Arm Description
    50 Patients-Post-operatively patients will receive bilateral SPIP blocks by injecting 20 mL of 0.25% bupivacaine (on each side) between the pectoralis major and external intercostal muscle aponeurosis at 2 cm lateral to the right and left of the sternal edge, corresponding to the fifth rib. This group of patients will also receive unilateral TAP block by injecting 20 mL of 0.25% bupivacaine in the plane between the internal oblique and transversus abdominis muscles.
    Intervention Type
    Procedure
    Intervention Name(s)
    SPIP and TAP Block
    Intervention Description
    Injection of Bupivacaine 0.25% for SPIP Block and TAP Block.
    Intervention Type
    Procedure
    Intervention Name(s)
    SPIP Block
    Intervention Description
    Injection of Bupivacaine 0.25% for SPIP Block
    Primary Outcome Measure Information:
    Title
    Post-operative total opioid consumption (oral morphine equivalents)
    Description
    Total Opioid consumption 24 hours post surgery oral moral morphine equivalents
    Time Frame
    24 hours after surgery
    Title
    Visual analog scale (VAS) pain scores
    Description
    Pain Scores measured via a Visual Analog Scale (0-10, Higher scores mean worse outcome)
    Time Frame
    6 hours after surgery
    Title
    Visual analog scale (VAS) pain scores
    Description
    Pain Scores measured via a Visual Analog Scale (0-10, Higher scores mean worse outcome)
    Time Frame
    12 hours after surgery
    Title
    Visual analog scale (VAS) pain scores
    Description
    Pain Scores measured via a Visual Analog Scale (0-10, Higher scores mean worse outcome)
    Time Frame
    24 hours after surgery
    Title
    Length of hospital stay (LOS)
    Description
    The days spent in the hospital from surgery to discharge
    Time Frame
    Up to 1 month
    Secondary Outcome Measure Information:
    Title
    Incidence of post-operation nausea and vomiting (PONV)
    Description
    The percentage of the patients who had post-operative nausea and vomiting (PONV) within 24 hours of surgery
    Time Frame
    24 hours
    Title
    Acetaminophen consumption
    Description
    Total acetaminophen consumption in mg 24 hr after surgery
    Time Frame
    24 hours after surgery
    Title
    NSAID (ketorolac) consumption
    Description
    Total NSAID consumption in mg
    Time Frame
    24 hours after surgery
    Title
    Length of ICU stay
    Description
    Length of stay in Intensive Care Unit from surgery to discharge from Intensive Care Unit
    Time Frame
    Up to 1 month
    Title
    Time to extubation
    Description
    Time it took for patient to be extubated
    Time Frame
    24 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: - Patients undergoing primary coronary artery bypass grafting Exclusion Criteria: Patients with significant genetic or acquired clotting/bleeding disorders (hemophilia, DIC, etc.) Patients with significant platelet dysfunction Infection at site for regional anesthesia Allergy to local anesthetics Severe aortic stenosis Severe mitral stenosis Sepsis
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sandeep Krishnan, M.D.
    Phone
    (248) 858-6068
    Email
    sakrishna@med.wayne.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Are Superficial Parasternal Intercostal Plane (SPIP) Blocks With Bupivacaine and With or Without Transversus Abdominis Plane Block (TAP) Helpful for Post-operative Pain After Coronary Artery Bypass Grafting?

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