CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 70 enrolled
Drug / intervention
Liposomal bupivacaine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04333095
NCT04333095Phase 4Completed

Regional Blockade of the Sternum With Liposomal Bupivacaine Prior to Incision Decreases Opioid Use in Patients Undergoing Cardiac Surgery (Sternal Block)

Baylor Research Institute·interventional·Posted Apr 3, 2020·Updated Feb 20, 2026

In Brief

A Phase 4 clinical trial evaluating Liposomal bupivacaine and Normal Saline Flush, 0.9% Injectable Solution_#1 for Cardiovascular Surgery and 2 related conditions. Completed, enrolled 70 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedApr 3, 2020
Enrollment StartFeb 6, 2020
Primary CompletionJun 23, 2021
Study CompletionJun 26, 2021
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 6.2 years ago

Interventions

Liposomal bupivacainedrug

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

Normal Saline Flush, 0.9% Injectable Solution_#1drug

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