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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04282239
• Other study ID #: 19-01675
• Status: Withdrawn
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: July 2022

Study information

• Verified date: December 2021
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Surgery
• Pain, Postoperative

Intervention

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
• Lidocaine Epinephrine
10 mL on each side of anterior chest for a total of 20mL
• Dexmedetomidine 0.004 MG/ML
10 mL

Locations

Country	Name	City	State
United States	NYU Winthrop Hospital	Mineola	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	24 hours
Primary	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)	24 hours
Secondary	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.	0-6 hours
Secondary	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.	4-6 hours
Secondary	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	5-7 hours
Secondary	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).	Intraoperative duration
Secondary	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.	24-48 hours
Secondary	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.	5-7 days post-operative
Secondary	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.	24-48 hours
Secondary	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.	24-48 hours
Secondary	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.	24-48 hours
Secondary	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).	5-7 days post-operative
Secondary	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	24-48 hours
Secondary	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	24-48 hours
Secondary	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.	5-7 days post-operative