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

NYU Langone Health

Status: Withdrawn

Conditions: Cardiac Surgery; Pain, Postoperative

Treatments: Drug: Lidocaine Epinephrine; Procedure: PECS2 block; Drug: Dexmedetomidine 0.004 MG/ML; Drug: Ropivacaine 0.5% Injectable Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT04282239

19-01675

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Pectoral nerves block type 2 (PECS2)

Experimental group

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.

Treatment:

Procedure: PECS2 block

Drug: Dexmedetomidine 0.004 MG/ML

Drug: Lidocaine Epinephrine

Drug: Ropivacaine 0.5% Injectable Solution

Control Group: standard post-operative pain regimen

No Intervention group

Description:

Patients will receive a standard post-operative pain regimen per institutional protocol.