Parasternal Subpectoral Plane Blocks for Cardiac Surgery Via a Midline Sternotomy

NCT04788056 | Withdrawn DMC

• 1 other identifier: 2021P000486
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

To better determine whether parasternal subpectoral plane blocks (PSPB) infusing bupivacaine for midline sternotomy decreases opioid consumption and pain scores. This is a prospective, blinded randomized controlled trial with 2 arms. 1 arm is the saline control arm, PSPB catheters will be placed with saline and continue to infuse saline. The other arm is bupivacaine study arm, PSPB catheters will be placed with bupivacaine and continue to infuse the local anesthetic.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• Opioid Consumption

  Cumulative opioid consumption on post-operative day 1 and 2

  2 days

Secondary Outcomes (9)

• Acute Postoperative Pain scores

  through initial hospital stay, an average of 5 days

• Persistent Postoperative Pain scores

  Measured at 1 year

• Pain and patient characteristics

  1 year

• Incidence of arrhythmia

  Hospital stay, an average of 5 days

• Time to extubation

  Post-operative day 1

Study Arms (2)

Bupivacaine

EXPERIMENTAL

PSPB catheters will be placed with 60mL of 0.2% bupivacaine and continue to infuse bupivacaine 0.125% at 10mL/hr through the catheter

Procedure: Parasternal Subpectoral Plane Block

Saline

PLACEBO COMPARATOR

PSPB catheters will be placed with 60mL of saline and continue to infuse saline through the catheters.

Procedure: Parasternal Subpectoral Plane Block

Interventions

Parasternal Subpectoral Plane Block PROCEDURE

Nerve block catheter inserted into plane between rib cartilages and pectoralis muscle.

Bupivacaine; Saline

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or Female
• Aged 18 - 80 years
• scheduled for primary elective cardiac surgery via median sternotomy
• willingness to undergo psychosocial testing
• willingness to participate in long-term follow up
• willingness to be randomized to receive local anesthetic or saline infusion through PSPB catheters
• access to an email and computer

You may not qualify if:

• Allergy to opioids
• allergy to bupivacaine
• emergency surgery
• unable to provide informed consent
• weight less than 50kg

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Related Publications (4)

• Lahtinen P, Kokki H, Hynynen M. Pain after cardiac surgery: a prospective cohort study of 1-year incidence and intensity. Anesthesiology. 2006 Oct;105(4):794-800. doi: 10.1097/00000542-200610000-00026.

  PMID: 17006079 BACKGROUND

• Huang AP, Sakata RK. Pain after sternotomy - review. Braz J Anesthesiol. 2016 Jul-Aug;66(4):395-401. doi: 10.1016/j.bjane.2014.09.013. Epub 2016 Apr 23.

  PMID: 27343790 BACKGROUND

• Edwards RR, Cahalan C, Mensing G, Smith M, Haythornthwaite JA. Pain, catastrophizing, and depression in the rheumatic diseases. Nat Rev Rheumatol. 2011 Apr;7(4):216-24. doi: 10.1038/nrrheum.2011.2. Epub 2011 Feb 1.

  PMID: 21283147 BACKGROUND

• Taillefer MC, Carrier M, Belisle S, Levesque S, Lanctot H, Boisvert AM, Choiniere M. Prevalence, characteristics, and predictors of chronic nonanginal postoperative pain after a cardiac operation: a cross-sectional study. J Thorac Cardiovasc Surg. 2006 Jun;131(6):1274-80. doi: 10.1016/j.jtcvs.2006.02.001.

  PMID: 16733157 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Officials

• Kamen Vlassakov, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Saline and Bupivacaine are both clear fluids and look identical. Research pharmacy will prepare blinded solutions for use in study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Regional Anesthesia

Study Record Dates

• First Submitted: February 26, 2021
• First Posted: March 9, 2021
• Study Start: June 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2023
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share