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

Not Applicable

Withdrawn

• Conditions: Pain, Postoperative; Cardiac Surgery
• Interventions: Procedure: PECS2 block; Drug: Ropivacaine 0.5% Injectable Solution; Drug: Lidocaine Epinephrine; Drug: Dexmedetomidine 0.004 MG/ML

• Registration Number: NCT04282239
• Lead Sponsor: 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.

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2020-02-19
• Study First Submitted QC: 2020-02-21
• Study First Posted: 2020-02-24
• Study Start: 2021-03-01
• Status Verified: 2021-12
• Primary Completion: 2021-12
• Last Update Submitted: 2021-12-08
• Last Update Posted: 2021-12-29
• Study Completion: 2022-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pectoral nerves block type 2 (PECS2)	PECS2 block	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.
Pectoral nerves block type 2 (PECS2)	Ropivacaine 0.5% Injectable Solution	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.
Pectoral nerves block type 2 (PECS2)	Dexmedetomidine 0.004 MG/ML	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.
Pectoral nerves block type 2 (PECS2)	Lidocaine Epinephrine	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.

Primary Outcome Measures

Name	Time	Method
Score on Critical-Care Pain Assessment Tool (CPOT)	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)	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

Name	Time	Method
Duration of hospital stay	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.
Total post-operative opiate dose	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).
Score on Visual Analog Scale (VAS) at 24-48h	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
Ventilatory duration post-operatively	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.
Duration of surgery	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.
Time to first opiate dose for breakthrough pain	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.
Duration of operating room time	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
Total intraoperative fentanyl dose	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).
Duration of ICU stay	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.
Time to first analgesic post-operatively	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.
Number of episodes of post-operative breakthrough pain	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.
Score on Critical-Care Pain Assessment Tool (CPOT) at 24-48h	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
Number of adverse events related to safety of the nerve block	5-7 days post-operative	Adverse events including but not limited to hemodynamic instability, respiratory depression, allergic reaction, shivering.

Trial Locations

Locations (1)

NYU Winthrop Hospital; 🇺🇸 Mineola, New York, United States