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Parasternal Subpectoral Plane Blocks for Cardiac Surgery Via a Midline Sternotomy

Primary Purpose

Pain, Postoperative

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Parasternal Subpectoral Plane Block
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or Female
  2. Aged 18 - 80 years
  3. scheduled for primary elective cardiac surgery via median sternotomy
  4. willingness to undergo psychosocial testing
  5. willingness to participate in long-term follow up
  6. willingness to be randomized to receive local anesthetic or saline infusion through PSPB catheters
  7. access to an email and computer

Exclusion Criteria:

  1. Allergy to opioids
  2. allergy to bupivacaine
  3. emergency surgery
  4. unable to provide informed consent
  5. weight less than 50kg

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Bupivacaine

    Saline

    Arm Description

    PSPB catheters will be placed with 60mL of 0.2% bupivacaine and continue to infuse bupivacaine 0.125% at 10mL/hr through the catheter

    PSPB catheters will be placed with 60mL of saline and continue to infuse saline through the catheters.

    Outcomes

    Primary Outcome Measures

    Opioid Consumption
    Cumulative opioid consumption on post-operative day 1 and 2

    Secondary Outcome Measures

    Acute Postoperative Pain scores
    At rest and activity, on a numerical rating scale (NRS) 0-10
    Persistent Postoperative Pain scores
    Persistent midline sternotomy pain, on a numerical rating scale (NRS) 0-10
    Pain and patient characteristics
    Whether there is a correlation between development of persistent post-sternotomy pain and psychosocial/psychophysical characteristics. Will be ascertained from a variety of questionnaires (i.e. brief pain index, brief symptom inventory, coping strategies, fibromyalgianess, pain catastrophizing scale, positive and negative affect scale, PROMIS anxiety short form (SF), PROMIS depression SF, PROMIS sleep disturbance SF
    Incidence of arrhythmia
    Whether active bupivacaine group has lower incidence of arrythmia versus saline control group. And whether this correlates to a certain plasma bupivacine level
    Time to extubation
    From arrival time to ICU to extubation
    Length of ICU stay
    When patients are deemed ready to be discharged from ICU
    Length of hospital stay
    When patients are deemed ready to be discharged from hospital
    Incidence of delirium
    Assessed using CAM-ICU
    Time to first opioid administration after extubation
    When patient first requests opioid after extubation

    Full Information

    First Posted
    February 26, 2021
    Last Updated
    March 4, 2021
    Sponsor
    Brigham and Women's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04788056
    Brief Title
    Parasternal Subpectoral Plane Blocks for Cardiac Surgery Via a Midline Sternotomy
    Official Title
    Parasternal Subpectoral Plane Blocks for Patients Undergoing Cardiac Surgery Involving Median Sternotomy - a Study of Opioid and Pain Reduction
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2021 (Anticipated)
    Primary Completion Date
    June 2022 (Anticipated)
    Study Completion Date
    June 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Brigham and Women's Hospital

    4. Oversight

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

    5. Study Description

    Brief Summary
    To better determine whether parasternal subpectoral plane blocks (PSPB) infusing bupivacaine for midline sternotomy decreases opioid consumption and pain scores. This is a prospective, blinded randomized controlled trial with 2 arms. 1 arm is the saline control arm, PSPB catheters will be placed with saline and continue to infuse saline. The other arm is bupivacaine study arm, PSPB catheters will be placed with bupivacaine and continue to infuse the local anesthetic.
    Detailed Description
    Subjects will be randomized to receive PSPB catheters infusing either bupivacaine or saline. Randomization will be achieved using a computer-generated randomization scheme. The surgeon, nurse, anesthetist and patient will be blinded. The investigational drug service will prepare blinded solutions (bupivacaine 0.2% or saline syringes) for performance of the block. They will also prepare bags (either bupivacaine 0.125% or saline) to be infused through the catheter. Following skin closure, but before removal of the surgical drapes, regional anesthesiologists will scrub in, gown and perform the placement of PSPB catheters under strict surgical aseptic technique. Real-time ultrasound (US) imaging will be used to visualize the pectoralis major muscle and its corresponding rib cartilages, and a needle/introducer sheath will be guided parasternally into the fascial plane. The needle will be advanced in the plane, hydro-dissecting with 30 mL of bupivacaine 0.2% in the study group or 30 mL of saline in the control group per side. Following hydro-dissection, a 5 in. multiport catheter will be inserted via the sheath, and the catheter will be secured following US confirmation of appropriate catheter position. This procedure will then be repeated on the other side. After completion of bilateral PSPB catheters, patients will remain intubated and be transferred to the CSICU on a sedation regimen at the discretion of the intraoperative anesthesia team. Upon dropping off to the ICU, each catheter will be attached to a programmable pump infusing plain bupivacaine 0.125% at 10 mL/hr or saline infusing at 10 mL/hr. Once again, the solution to be infused postoperatively will be prepared by pharmacy and blinded from the patient, nurse, and postoperative pain service providers.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    Saline and Bupivacaine are both clear fluids and look identical. Research pharmacy will prepare blinded solutions for use in study.
    Allocation
    Randomized
    Enrollment
    154 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Bupivacaine
    Arm Type
    Experimental
    Arm Description
    PSPB catheters will be placed with 60mL of 0.2% bupivacaine and continue to infuse bupivacaine 0.125% at 10mL/hr through the catheter
    Arm Title
    Saline
    Arm Type
    Placebo Comparator
    Arm Description
    PSPB catheters will be placed with 60mL of saline and continue to infuse saline through the catheters.
    Intervention Type
    Procedure
    Intervention Name(s)
    Parasternal Subpectoral Plane Block
    Intervention Description
    Nerve block catheter inserted into plane between rib cartilages and pectoralis muscle.
    Primary Outcome Measure Information:
    Title
    Opioid Consumption
    Description
    Cumulative opioid consumption on post-operative day 1 and 2
    Time Frame
    2 days
    Secondary Outcome Measure Information:
    Title
    Acute Postoperative Pain scores
    Description
    At rest and activity, on a numerical rating scale (NRS) 0-10
    Time Frame
    through initial hospital stay, an average of 5 days
    Title
    Persistent Postoperative Pain scores
    Description
    Persistent midline sternotomy pain, on a numerical rating scale (NRS) 0-10
    Time Frame
    Measured at 1 year
    Title
    Pain and patient characteristics
    Description
    Whether there is a correlation between development of persistent post-sternotomy pain and psychosocial/psychophysical characteristics. Will be ascertained from a variety of questionnaires (i.e. brief pain index, brief symptom inventory, coping strategies, fibromyalgianess, pain catastrophizing scale, positive and negative affect scale, PROMIS anxiety short form (SF), PROMIS depression SF, PROMIS sleep disturbance SF
    Time Frame
    1 year
    Title
    Incidence of arrhythmia
    Description
    Whether active bupivacaine group has lower incidence of arrythmia versus saline control group. And whether this correlates to a certain plasma bupivacine level
    Time Frame
    Hospital stay, an average of 5 days
    Title
    Time to extubation
    Description
    From arrival time to ICU to extubation
    Time Frame
    Post-operative day 1
    Title
    Length of ICU stay
    Description
    When patients are deemed ready to be discharged from ICU
    Time Frame
    From arrival to ICU to discharge to floor, up to 5 days
    Title
    Length of hospital stay
    Description
    When patients are deemed ready to be discharged from hospital
    Time Frame
    From arrival to ICU to discharge from hospital, up to 5 days
    Title
    Incidence of delirium
    Description
    Assessed using CAM-ICU
    Time Frame
    Time in ICU to discharge to floor, up to 3 days
    Title
    Time to first opioid administration after extubation
    Description
    When patient first requests opioid after extubation
    Time Frame
    Extubation to first opioid administration, up to 3 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or Female Aged 18 - 80 years scheduled for primary elective cardiac surgery via median sternotomy willingness to undergo psychosocial testing willingness to participate in long-term follow up willingness to be randomized to receive local anesthetic or saline infusion through PSPB catheters access to an email and computer Exclusion Criteria: Allergy to opioids allergy to bupivacaine emergency surgery unable to provide informed consent weight less than 50kg
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kamen Vlassakov, MD
    Phone
    6177328221
    Email
    kvlassakov@bwh.harvard.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kamen Vlassakov, MD
    Organizational Affiliation
    Brigham and Women's Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    17006079
    Citation
    Lahtinen P, Kokki H, Hynynen M. Pain after cardiac surgery: a prospective cohort study of 1-year incidence and intensity. Anesthesiology. 2006 Oct;105(4):794-800. doi: 10.1097/00000542-200610000-00026.
    Results Reference
    background
    PubMed Identifier
    27343790
    Citation
    Huang AP, Sakata RK. Pain after sternotomy - review. Braz J Anesthesiol. 2016 Jul-Aug;66(4):395-401. doi: 10.1016/j.bjane.2014.09.013. Epub 2016 Apr 23.
    Results Reference
    background
    PubMed Identifier
    21283147
    Citation
    Edwards RR, Cahalan C, Mensing G, Smith M, Haythornthwaite JA. Pain, catastrophizing, and depression in the rheumatic diseases. Nat Rev Rheumatol. 2011 Apr;7(4):216-24. doi: 10.1038/nrrheum.2011.2. Epub 2011 Feb 1. Erratum In: Nat Rev Rheumatol.. Correction on page following 224. Nat Rev Rheumatol. 2011 Jun;7(6):314. Calahan, Christine [corrected to Cahalan, Christine].
    Results Reference
    background
    PubMed Identifier
    16733157
    Citation
    Taillefer MC, Carrier M, Belisle S, Levesque S, Lanctot H, Boisvert AM, Choiniere M. Prevalence, characteristics, and predictors of chronic nonanginal postoperative pain after a cardiac operation: a cross-sectional study. J Thorac Cardiovasc Surg. 2006 Jun;131(6):1274-80. doi: 10.1016/j.jtcvs.2006.02.001.
    Results Reference
    background

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    Parasternal Subpectoral Plane Blocks for Cardiac Surgery Via a Midline Sternotomy

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