Sternal Block With Liposomal Bupivacaine vs. Saline Prior to Incision in Cardiac Surgery

NCT04333095 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 019-296
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to find out what effects (good and bad) that the study medicine called "liposomal bupivacaine" has on subjects that are undergoing a sternotomy. Liposomal bupivacaine solution, is a drug that the doctor will inject before they make the cut through patient's breastbone (sternotomy). Normally pain medicine like this is given right before the surgeon closes up the patient's breastbone, at the end of the surgery. For this study, they want to see if giving the medicine before they make the cut into the patient's breastbone helps their pain. They also want to find out if patients feel less pain after surgery with the study drug than they do with saline and possibly decrease the need for pain medicine. Subjects will be in the study for about 72 hours or until they are discharged from the hospital.

Conditions

Cardiovascular Surgery; Pain, Postoperative; Block

Outcome Measures

Primary Outcomes (2)

• Total Postoperative Opioid Measured in Milligram Morphine Equivalent (MME) at 72 Hours

  The amount of opioid medications used will be recorded during the routine postoperative course.

  Up to 72 hours post-op

• Intraoperative Opioid Usage Measured in Milligram Morphine Equivalent (MME)

  To demonstrate decreased intraoperative opioid usage in the treatment group compared to controls

  During surgery, up to 7 hours

Study Arms (2)

Liposomal Bupivacaine Block

ACTIVE COMPARATOR

Liposomal Bupivacaine (1.3%) solution (20 mL dose). This solution has demonstrated increased efficacy in prolonged analgesia following injection. This solution will be injected as an ultrasound-guided subpectoral interfacial plane block.

Drug: Liposomal bupivacaine

Saline Block

PLACEBO COMPARATOR

Normal saline (0.9%) will be used as the control solution for patients not receiving the liposomal bupivacaine solution. Injection procedure of this solution will be identical to that of the liposomal bupivacaine solution.

Drug: Normal Saline Flush, 0.9% Injectable Solution_#1

Interventions

Liposomal bupivacaine DRUG

Sternal Block during Coronary Artery Bypass Graft Surgery and/or surgical aortic valve replacement through mini- or full sternotomy

Liposomal Bupivacaine Block

Normal Saline Flush, 0.9% Injectable Solution_#1 DRUG

Sternal Block during Coronary Artery Bypass Graft Surgery and/or surgical aortic valve replacement through mini- or full sternotomy

Saline Block

Eligibility Criteria

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

You may qualify if:

• Age greater than 18 years
• Undergoing a surgical procedure through mini- or full sternotomy.

You may not qualify if:

• Clinical instability
• Allergic to liposomal bupivacaine solution or any of its ingredients
• Maximum-allowed dosage of local analgesia will be exceeded by the injection amount of liposomal bupivacaine used in this study (\<50 kg).
• BMI \>45
• Pregnant or nursing
• Chronic home opioid usage
• Left Ventricular Ejection Fraction (LVEF) \< 30%
• Low cardiac output requiring mechanical or inotropic support
• End-stage renal disease
• Cirrhosis

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor Scott & White Heart Hospital - Plano

Plano, Texas, 75093, United States

Location

Related Publications (5)

• Bignami E, Castella A, Pota V, Saglietti F, Scognamiglio A, Trumello C, Pace MC, Allegri M. Perioperative pain management in cardiac surgery: a systematic review. Minerva Anestesiol. 2018 Apr;84(4):488-503. doi: 10.23736/S0375-9393.17.12142-5. Epub 2017 Oct 12.

  PMID: 29027773 BACKGROUND

• Dowling R, Thielmeier K, Ghaly A, Barber D, Boice T, Dine A. Improved pain control after cardiac surgery: results of a randomized, double-blind, clinical trial. J Thorac Cardiovasc Surg. 2003 Nov;126(5):1271-8. doi: 10.1016/s0022-5223(03)00585-3.

  PMID: 14665996 BACKGROUND

• Barr AM, Tutungi E, Almeida AA. Parasternal intercostal block with ropivacaine for pain management after cardiac surgery: a double-blind, randomized, controlled trial. J Cardiothorac Vasc Anesth. 2007 Aug;21(4):547-53. doi: 10.1053/j.jvca.2006.09.003. Epub 2006 Dec 22.

  PMID: 17678782 BACKGROUND

• Lee CY, Robinson DA, Johnson CA Jr, Zhang Y, Wong J, Joshi DJ, Wu TT, Knight PA. A Randomized Controlled Trial of Liposomal Bupivacaine Parasternal Intercostal Block for Sternotomy. Ann Thorac Surg. 2019 Jan;107(1):128-134. doi: 10.1016/j.athoracsur.2018.06.081. Epub 2018 Aug 28.

  PMID: 30170012 BACKGROUND

• Labrum JT 4th, Ilyas AM. Preemptive Analgesia in Thumb Basal Joint Arthroplasty: Immediate Postoperative Pain with Preincision versus Postincision Local Anesthesia. J Hand Microsurg. 2017 Aug;9(2):80-83. doi: 10.1055/s-0037-1603734. Epub 2017 Jun 5.

  PMID: 28867907 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Bites and Stings

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Limitations and Caveats

A possible limitation is the overestimation of MME usage in the initial power analysis while calculating the sample size.

Results Point of Contact

• Title: Sarah Hale, Project Manager
• Organization: Baylor Scott & White Research Institute

Sarah.Hale@BSWHealth.org

469-814-4845

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The surgeon, coordinator and anesthesiologist on the case are blinded to the block drug. A 2nd (unblinded) anesthesiologist performs the block on the patient.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2020
• First Posted: April 3, 2020
• Study Start: February 6, 2020
• Primary Completion: June 23, 2021
• Study Completion: June 26, 2021
• Last Updated: February 20, 2026
• Results First Posted: October 22, 2025

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)