Back to resultsPectoral Nerves Block to Relieve Post-sternotomy Pain After Cardiac Surgery
Primary Purpose
Pain, Postoperative, Cardiac Surgery
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PECS2 block
Ropivacaine 0.5% Injectable Solution
Lidocaine Epinephrine
Dexmedetomidine 0.004 MG/ML
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative
Eligibility Criteria
Inclusion Criteria:
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.
- Willingness and ability to participate in the study procedures
- 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
Sites / Locations
- NYU Winthrop Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Pectoral nerves block type 2 (PECS2)
Control Group: standard post-operative pain regimen
Arm Description
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.
Patients will receive a standard post-operative pain regimen per institutional protocol.
Outcomes
Primary Outcome Measures
Score on Critical-Care Pain Assessment Tool (CPOT)
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).
Score on Visual Analog Scale (VAS)
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
Ventilatory duration post-operatively
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.
Duration of surgery
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.
Duration of operating room time
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
Total intraoperative fentanyl dose
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).
Duration of ICU stay
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.
Duration of hospital stay
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.
Time to first opiate dose for breakthrough pain
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.
Time to first analgesic post-operatively
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.
Number of episodes of post-operative breakthrough pain
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.
Total post-operative opiate dose
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).
Score on Critical-Care Pain Assessment Tool (CPOT) at 24-48h
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
Score on Visual Analog Scale (VAS) at 24-48h
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
Number of adverse events related to safety of the nerve block
Adverse events including but not limited to hemodynamic instability, respiratory depression, allergic reaction, shivering.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04282239
Brief Title
Pectoral Nerves Block to Relieve Post-sternotomy Pain After Cardiac Surgery
Official Title
Pectoral Nerves Block to Relieve Post-sternotomy Pain After Cardiac Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Did not have the staff to conduct the study
Study Start Date
March 1, 2021 (Anticipated)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
July 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
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.
Yes
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Cardiac Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Double-blind
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pectoral nerves block type 2 (PECS2)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group: standard post-operative pain regimen
Arm Type
No Intervention
Arm Description
Patients will receive a standard post-operative pain regimen per institutional protocol.
Intervention Type
Procedure
Intervention Name(s)
PECS2 block
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine 0.5% Injectable Solution
Intervention Description
15 mL on each side of anterior chest for a total of 30mL
Intervention Type
Drug
Intervention Name(s)
Lidocaine Epinephrine
Intervention Description
10 mL on each side of anterior chest for a total of 20mL
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine 0.004 MG/ML
Intervention Description
10 mL
Primary Outcome Measure Information:
Title
Score on Critical-Care Pain Assessment Tool (CPOT)
Description
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).
Time Frame
24 hours
Title
Score on Visual Analog Scale (VAS)
Description
Measured at least hourly after extubation. 10 point pain analog scale (0-10, where 0 is no pain and 10 is highest pain level)
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Ventilatory duration post-operatively
Description
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.
Time Frame
0-6 hours
Title
Duration of surgery
Description
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.
Time Frame
4-6 hours
Title
Duration of operating room time
Description
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
Time Frame
5-7 hours
Title
Total intraoperative fentanyl dose
Description
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).
Time Frame
Intraoperative duration
Title
Duration of ICU stay
Description
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.
Time Frame
24-48 hours
Title
Duration of hospital stay
Description
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.
Time Frame
5-7 days post-operative
Title
Time to first opiate dose for breakthrough pain
Description
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.
Time Frame
24-48 hours
Title
Time to first analgesic post-operatively
Description
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.
Time Frame
24-48 hours
Title
Number of episodes of post-operative breakthrough pain
Description
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.
Time Frame
24-48 hours
Title
Total post-operative opiate dose
Description
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).
Time Frame
5-7 days post-operative
Title
Score on Critical-Care Pain Assessment Tool (CPOT) at 24-48h
Description
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
Time Frame
24-48 hours
Title
Score on Visual Analog Scale (VAS) at 24-48h
Description
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
Time Frame
24-48 hours
Title
Number of adverse events related to safety of the nerve block
Description
Adverse events including but not limited to hemodynamic instability, respiratory depression, allergic reaction, shivering.
Time Frame
5-7 days post-operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Willingness and ability to participate in the study procedures
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sunil Abrol, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Winthrop Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD Sharing 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.
IPD Sharing 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.
Learn more about this trial
Pectoral Nerves Block to Relieve Post-sternotomy Pain After Cardiac Surgery
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