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

NCT ID: NCT04282239

Last Updated: 2021-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2022-07-31

Brief Summary

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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

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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

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Pain, Postoperative Cardiac Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Double-blind

Study Groups

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Pectoral nerves block type 2 (PECS2)

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.

Group Type EXPERIMENTAL

PECS2 block

Intervention Type PROCEDURE

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 Solution

Intervention Type DRUG

15 mL on each side of anterior chest for a total of 30mL

Lidocaine Epinephrine

Intervention Type DRUG

10 mL on each side of anterior chest for a total of 20mL

Dexmedetomidine 0.004 MG/ML

Intervention Type DRUG

10 mL

Control Group: standard post-operative pain regimen

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type PROCEDURE

Ropivacaine 0.5% Injectable Solution

15 mL on each side of anterior chest for a total of 30mL

Intervention Type DRUG

Lidocaine Epinephrine

10 mL on each side of anterior chest for a total of 20mL

Intervention Type DRUG

Dexmedetomidine 0.004 MG/ML

10 mL

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sunil Abrol, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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NYU Winthrop Hospital

Mineola, New York, United States

Site Status

Countries

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United States

Other Identifiers

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19-01675

Identifier Type: -

Identifier Source: org_study_id