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Pectoral Nerves Block to Relieve Post-sternotomy Pain After Cardiac Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04282239
Recruitment Status : Not yet recruiting
First Posted : February 24, 2020
Last Update Posted : February 24, 2020
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:
The primary objective of this study is to determine if the addition of PECS2 block provides superior post-operative analgesia for cardiac surgery patients after midline sternotomy compared to only standard-of-care post-operative pain medication.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Cardiac Surgery Procedure: PECS2 block Drug: Ropivacaine 0.5% Injectable Solution Drug: Lidocaine Epinephrine Drug: Dexmedetomidine 0.004 MG/ML Not Applicable

Detailed Description:
The current study is a prospective, double-blind study investigating the use of pectoral nerves (PECS) block 2 to alleviate post-operative pain in cardiac surgery patients. The investigators anticipate enrolling a total of 220 participants in one of two groups, an interventional PECS block group and a control group not receiving the block. The intervention will occur in the operating room after the completion of the cardiac procedure and prior to the transfer of the participants to the cardiothoracic intensive care unit (CTICU). Both groups will receive the standard-of-care (SOC) pain regimen; the intervention with receive the PECS block in addition to SOC pain regimen. The procedure takes approximately five to ten minutes and will be conducted by the attending cardiac anesthesiologist. Pain will then be monitored hourly in the post-operative period in the CTICU. Additional measures will be investigated that are regularly logged in the electronic medical record.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Double-blind
Primary Purpose: Treatment
Official Title: Pectoral Nerves Block to Relieve Post-sternotomy Pain After Cardiac Surgery
Estimated Study Start Date : February 21, 2020
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : March 7, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
Experimental: Pectoral nerves block type 2 (PECS2)
The intervention is the PECS2 block, a previously developed modality for preventing pain in the anterior chest. The medication used in the block is Ropivicaine 0.5%, Lidocaine 1% + 1:100,000 epinephrine, and 40 μg dexmedetomidine. Patients will receive a standard post-operative pain regimen per institutional protocol.
Procedure: PECS2 block
Superficial peripheral nerve block placed at the interfascial plane between the pectoralis major and minor muscles and the plane between the pectoralis minor and serrates anterior muscles. Targeted nerves include the lateral and medial pectoral nerves in addition to the long thoracic nerve, thoracodorsal, and thoracic intercostal nerves from T2 to T6.

Drug: Ropivacaine 0.5% Injectable Solution
15 mL on each side of anterior chest for a total of 30mL

Drug: Lidocaine Epinephrine
10 mL on each side of anterior chest for a total of 20mL

Drug: Dexmedetomidine 0.004 MG/ML
10 mL

No Intervention: Control Group: standard post-operative pain regimen
Patients will receive a standard post-operative pain regimen per institutional protocol.



Primary Outcome Measures :
  1. Score on Critical-Care Pain Assessment Tool (CPOT) [ Time Frame: 24 hours ]
    Measured at least hourly prior to extubation. This is an 8-item pain inventory seen as one of the top modalities for measuring pain in critical care patients. Minimum score of 0 and a maximum score of 8 (higher score = higher pain level).

  2. Score on Visual Analog Scale (VAS) [ Time Frame: 24 hours ]
    Measured at least hourly after extubation. 10 point pain analog scale (0-10, where 0 is no pain and 10 is highest pain level)


Secondary Outcome Measures :
  1. Ventilatory duration post-operatively [ Time Frame: 0-6 hours ]
    Documented by nursing, physician assistants, physician, and/or respiratory staff as standard of care - will be retrieved in the EMR. The scale is a time scale with the time of 0 corresponding to the "out of operating room" time and the final time being the time period from the 0 time to the time when the patient is extubated.

  2. Duration of surgery [ Time Frame: 4-6 hours ]
    Documented by nursing, physician assistants, physician, and/or respiratory staff as standard of care - will be retrieved in the EMR (Electronic Medical Records). The scale is a time scale with the time of 0 corresponding to the "first incision" time and the final time being the time period from the 0 time to the time when the PECS2 block is completed.

  3. Duration of operating room time [ Time Frame: 5-7 hours ]
    Documented by nursing, physician assistants, physician, and/or respiratory staff as standard of care - will be retrieved in the EMR. The scale is a time scale with the time of 0 corresponding to the "into operating room" time and the final time being the "out of operating room" time

  4. Total intraoperative fentanyl dose [ Time Frame: Intraoperative duration ]

    Documented by anesthesia physician as standard of care - will be retrieved in the EMR.

    The scale is an absolute dosing scale in grams. It will be corrected for by weight (kilograms).


  5. Duration of ICU stay [ Time Frame: 24-48 hours ]
    Documented by nursing, physician assistants, physician, and/or respiratory staff as standard of care - will be retrieved in the EMR. The scale is time. Time zero is "out of operating" time and end time is time of downgrade or discharge from the hospital.

  6. Duration of hospital stay [ Time Frame: 5-7 days post-operative ]
    Documented by nursing, physician assistants, physician, and/or respiratory staff as standard of care - will be retrieved in the EMR. The scale is a time with time zero corresponding to admission to hospital time and end time being the time of discharge from the hospital.

  7. Time to first opiate dose for breakthrough pain [ Time Frame: 24-48 hours ]
    Documented by nursing, physician assistants, physician, and/or respiratory staff as standard of care - will be retrieved in the EMR. The scale is time. Time zero will be "out of operating room" time and end time will be time of administration of first opiate pain medication.

  8. Time to first analgesic post-operatively [ Time Frame: 24-48 hours ]
    Documented by nursing, physician assistants, physician, and/or respiratory staff as standard of care - will be retrieved in the EMR. The scale is time. Time zero will be "out of operating room" time and end time will be time of administration of first breakthrough pain medication.

  9. Number of episodes of post-operative breakthrough pain [ Time Frame: 24-48 hours ]
    Documented by nursing, physician assistants, physician, and/or respiratory staff as standard of care - will be retrieved in the EMR. The scale is an absolute number documenting the number of documented episodes of breakthrough pain.

  10. Total post-operative opiate dose [ Time Frame: 5-7 days post-operative ]
    Documented by registered nurse as standard of care - will be retrieved in the EMR. The scale is an absolute dosing scale in grams. It will be corrected for by weight (kilograms).

  11. Score on Critical-Care Pain Assessment Tool (CPOT) at 24-48h [ Time Frame: 24-48 hours ]

    This is an 8-item pain inventory seen as one of the top modalities for measuring pain in critical care patients. Minimum score of 0 and a maximum score of 8 (higher score = higher pain level).

    Documented by nursing, physician assistants, physician, and/or respiratory staff as standard of care - will be retrieved in the EMR


  12. Score on Visual Analog Scale (VAS) at 24-48h [ Time Frame: 24-48 hours ]
    10 point pain analog scale (0-10, where 0 is no pain and 10 is highest pain level) Documented by nursing, physician assistants, physician, and/or respiratory staff as standard of care - will be retrieved in the EMR

  13. Number of adverse events related to safety of the nerve block [ Time Frame: 5-7 days post-operative ]
    Adverse events including but not limited to hemodynamic instability, respiratory depression, allergic reaction, shivering.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Obtaining one or more of the following elective surgical procedures at NYU Winthrop Hospital with midline sternotomy:

    • Coronary artery bypass graft (any number of vessels)
    • Aortic Valve Replacement (AVR)
    • Aortic Valve Repair
    • Mitral Valve Replacement (MVR)
    • Mitral Valve Repair
    • Tricuspid Valve Replacement
    • Tricuspid Valve Repair
    • Pulmonic Valve replacement
    • Pulmonic Valve Repair
    • Congenital Heart Defect Repair
    • Ascending Thoracic Aortic Aneurism Repair
    • Patient Age > 18 years.
  2. Willingness and ability to participate in the study procedures
  3. Sufficiently hemodynamically stable to give consent

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

  • Hemodynamic instability
  • Preexisting infection at site of block
  • Allergy to block agents
  • Severe psychiatric illness
  • Intubated emergently prior to reception by the perioperative team
  • Patient is preoperatively on extracorporeal membrane oxygenation (ECMO) treatment.
  • Pregnant patient
  • Recent surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04282239


Contacts
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Contact: Sunil Abrol, MD 516-663-4400 Sunil.abrol@nyulangone.org
Contact: Hadas Reshef, MD 516-663-2216 hadas.reshef@nyulangone.org

Locations
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United States, New York
NYU Winthrop Hospital
Mineola, New York, United States, 11501
Contact: Sunil Abrol, MD    516-663-4400    Sunil.abrol@nyulangone.org   
Contact: Hadas Reshef, MD    516-663-2216    hadas.reshef@nyulangone.org   
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Sunil Abrol, MD NYU Langone Health
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT04282239    
Other Study ID Numbers: 19-01675
First Posted: February 24, 2020    Key Record Dates
Last Update Posted: February 24, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Access Criteria: The investigator who proposed to use the data upon reasonable request. Requests should be directed to sunil.abrol@nyulangone.org and harrison.pravder@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

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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.: Yes
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Lidocaine
Epinephrine
Dexmedetomidine
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Analgesics
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Adrenergic beta-Agonists