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

NCT04282239 | Withdrawn

• 1 other identifier: 19-01675
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative; Cardiac Surgery

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (13)

• Ventilatory duration post-operatively

  0-6 hours

• Duration of surgery

  4-6 hours

• Duration of operating room time

  5-7 hours

• Total intraoperative fentanyl dose

  Intraoperative duration

• Duration of ICU stay

  24-48 hours

Study Arms (2)

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.

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.

Interventions

PECS2 block 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.

Pectoral nerves block type 2 (PECS2)

Ropivacaine 0.5% Injectable Solution DRUG

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

Pectoral nerves block type 2 (PECS2)

Lidocaine Epinephrine DRUG

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

Pectoral nerves block type 2 (PECS2)

Dexmedetomidine 0.004 MG/ML DRUG

10 mL

Pectoral nerves block type 2 (PECS2)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Willingness and ability to participate in the study procedures
• Sufficiently hemodynamically stable to give consent

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Winthrop Hospital

Mineola, New York, 11501, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine; Dexmedetomidine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Sunil Abrol, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: February 24, 2020
• Study Start: March 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: July 1, 2022
• Last Updated: December 29, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data upon reasonable request. Requests should be directed to sunil.abrol@nyulangone.org and harrison.pravder@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)