Pain, PostoperativeNCT04282239
Pectoral Nerves Block to Relieve Post-sternotomy Pain After Cardiac Surgery
A study testing PECS2 block, Ropivacaine 0.5% Injectable Solution and Lidocaine Epinephrine in people with Pain, Postoperative and Cardiac Surgery, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Pain, Postoperative, Cardiac Surgery
- What is being tested?
- PECS2 block, Ropivacaine 0.5% Injectable Solution and Lidocaine Epinephrine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- Patient is preoperatively on extracorporeal membrane oxygenation (ECMO) treatment.
- Pregnant patient
- Recent surgery
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Pain, Postoperative, Cardiac Surgery
- Being tested
- PECS2 block, Ropivacaine 0.5% Injectable Solution, Lidocaine Epinephrine, Dexmedetomidine 0.004 MG/ML
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PECS2 blockProcedure or surgery
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.
Ropivacaine 0.5% Injectable SolutionDrug
15 mL on each side of anterior chest for a total of 30mL
Lidocaine EpinephrineDrug
10 mL on each side of anterior chest for a total of 20mL
Dexmedetomidine 0.004 MG/MLDrug
10 mL
| Study group | Role | What they receive |
|---|---|---|
| Pectoral nerves block type 2 (PECS2) | Experimental | 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. Receives: Procedure: PECS2 block; Drug: Ropivacaine 0.5% Injectable Solution; Drug: Lidocaine Epinephrine; Drug: Dexmedetomidine 0.004 MG/ML |
| Control Group: standard post-operative pain regimen | No intervention | Patients will receive a standard post-operative pain regimen per institutional protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 24 hours
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)
Measured: 24 hours
Secondary outcomes (13)
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.
Measured: 0-6 hours
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.
Measured: 4-6 hours
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
Measured: 5-7 hours
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).
Measured: Intraoperative duration
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.
Measured: 24-48 hours
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.
Measured: 5-7 days post-operative
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.
Measured: 24-48 hours
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.
Measured: 24-48 hours
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.
Measured: 24-48 hours
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).
Measured: 5-7 days post-operative
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
Measured: 24-48 hours
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
Measured: 24-48 hours
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.
Measured: 5-7 days post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2020
- Study start1 Mar 2021 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionJul 2022 (estimated)
Why it stopped: Did not have the staff to conduct the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sunil Abrol, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04282239
- Sponsor's protocol ID
- 19-01675
- Status last verified
- Dec 2021
- First submitted
- 19 Feb 2020
- Last updated
- 29 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pectoral Nerves Block to Relieve Post-sternotomy Pain After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04282239
- Acronym / sponsor ID
- 19-01675
- Conditions
- Pain, Postoperative, Cardiac Surgery
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Did not have the staff to conduct the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 24 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pectoral nerves block type 2 (PECS2) | Experimental | Procedure: PECS2 block, Drug: Ropivacaine 0.5% Injectable Solution, Drug: Lidocaine Epinephrine, Drug: Dexmedetomidine 0.004 MG/MLThe 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. |
| Control Group: standard post-operative pain regimen | No intervention | –Patients will receive a standard post-operative pain regimen per institutional protocol. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Obtaining one or more of the following elective surgical procedures at NYU Winthrop Hospital with midline sternotomy:
- Willingness and ability to participate in the study procedures
- Sufficiently hemodynamically stable to give consent
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PECS2 blockSuperficial 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. | Procedure or surgery | Pectoral nerves block type 2 (PECS2) |
| Ropivacaine 0.5% Injectable Solution15 mL on each side of anterior chest for a total of 30mL | Drug | Pectoral nerves block type 2 (PECS2) |
| Lidocaine Epinephrine10 mL on each side of anterior chest for a total of 20mL | Drug | Pectoral nerves block type 2 (PECS2) |
| Dexmedetomidine 0.004 MG/ML10 mL | Drug | Pectoral nerves block type 2 (PECS2) |
Primary outcome
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).
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)
13 secondary outcomes
Ventilatory duration post-operatively
Time frame: 0-6 hours
Duration of surgery
Time frame: 4-6 hours
Duration of operating room time
Time frame: 5-7 hours
Total intraoperative fentanyl dose
Time frame: Intraoperative duration
Duration of ICU stay
Time frame: 24-48 hours
Duration of hospital stay
Time frame: 5-7 days post-operative
Time to first opiate dose for breakthrough pain
Time frame: 24-48 hours
Time to first analgesic post-operatively
Time frame: 24-48 hours
Number of episodes of post-operative breakthrough pain
Time frame: 24-48 hours
Total post-operative opiate dose
Time frame: 5-7 days post-operative
Score on Critical-Care Pain Assessment Tool (CPOT) at 24-48h
Time frame: 24-48 hours
Score on Visual Analog Scale (VAS) at 24-48h
Time frame: 24-48 hours
Number of adverse events related to safety of the nerve block
Time frame: 5-7 days post-operative
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2021.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sunil Abrol, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PECS2 block, Ropivacaine 0.5% Injectable Solution and Lidocaine Epinephrine in people with Pain, Postoperative and Cardiac Surgery, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score on Critical-Care Pain Assessment Tool (CPOT) (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2021.