Parasternal Subpectoral Plane Blocks for Cardiac Surgery Via a Midline Sternotomy

NCT ID: NCT04788056

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-30
• Study Completion Date: 2023-06-30

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.

Detailed Description

Subjects will be randomized to receive PSPB catheters infusing either bupivacaine or saline. Randomization will be achieved using a computer-generated randomization scheme. The surgeon, nurse, anesthetist and patient will be blinded. The investigational drug service will prepare blinded solutions (bupivacaine 0.2% or saline syringes) for performance of the block. They will also prepare bags (either bupivacaine 0.125% or saline) to be infused through the catheter.

Following skin closure, but before removal of the surgical drapes, regional anesthesiologists will scrub in, gown and perform the placement of PSPB catheters under strict surgical aseptic technique. Real-time ultrasound (US) imaging will be used to visualize the pectoralis major muscle and its corresponding rib cartilages, and a needle/introducer sheath will be guided parasternally into the fascial plane. The needle will be advanced in the plane, hydro-dissecting with 30 mL of bupivacaine 0.2% in the study group or 30 mL of saline in the control group per side. Following hydro-dissection, a 5 in. multiport catheter will be inserted via the sheath, and the catheter will be secured following US confirmation of appropriate catheter position. This procedure will then be repeated on the other side. After completion of bilateral PSPB catheters, patients will remain intubated and be transferred to the CSICU on a sedation regimen at the discretion of the intraoperative anesthesia team. Upon dropping off to the ICU, each catheter will be attached to a programmable pump infusing plain bupivacaine 0.125% at 10 mL/hr or saline infusing at 10 mL/hr. Once again, the solution to be infused postoperatively will be prepared by pharmacy and blinded from the patient, nurse, and postoperative pain service providers.

Conditions

Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Bupivacaine

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

Group Type: EXPERIMENTAL

Parasternal Subpectoral Plane Block

Intervention Type: PROCEDURE

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

Saline

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

Group Type: PLACEBO_COMPARATOR

Parasternal Subpectoral Plane Block

Intervention Type: PROCEDURE

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

Interventions

Parasternal Subpectoral Plane Block

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Male or Female

2. Aged 18 - 80 years

3. scheduled for primary elective cardiac surgery via median sternotomy

4. willingness to undergo psychosocial testing

5. willingness to participate in long-term follow up

6. willingness to be randomized to receive local anesthetic or saline infusion through PSPB catheters

7. access to an email and computer

Exclusion Criteria

1. Allergy to opioids

2. allergy to bupivacaine

3. emergency surgery

4. unable to provide informed consent

5. weight less than 50kg

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kamen Vlassakov

Director of Regional Anesthesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kamen Vlassakov, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

References

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.

Reference Type: BACKGROUND

PMID: 17006079 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27343790 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21283147 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16733157 (View on PubMed)

Other Identifiers

2021P000486

Identifier Type: -

Identifier Source: org_study_id