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Heart surgery pain relief: shot before incision cuts opioid use

NCT ID NCT04333095

Symptom relief Sponsor: Baylor Research Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether injecting a long-acting painkiller (liposomal bupivacaine) into the breastbone before cutting it during heart surgery can reduce pain and the need for opioid painkillers. 70 adults having heart surgery through the breastbone took part. The goal was to see if this approach works better than giving the same painkiller at the end of surgery.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

70 people

The number who actually took part.

Started

Feb 2020

Finished

Jun 2021

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age greater than 18 years 2. Undergoing a surgical procedure through mini- or full sternotomy. Exclusion Criteria: 1. Clinical instability 2. Allergic to liposomal bupivacaine solution or any of its ingredients 3. Maximum-allowed dosage of local analgesia will be exceeded by the injection amount of liposomal bupivacaine used in this study (\<50 kg). 4. BMI \>45 5. Pregnant or nursing 6. Chronic home opioid usage 7. Left Ventricular Ejection Fraction (LVEF) \< 30% 8. Low cardiac output requiring mechanical or inotropic support 9. End-stage renal disease 10. Cirrhosis

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Conditions

The condition(s) this trial relates to.

Bites and Stings Pain, Postoperative

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

BLOCK Cardiovascular surgery Pain, postoperative

Contacts and locations

Locations

  • Baylor Scott & White Heart Hospital - Plano

    Plano, Texas, 75093, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.