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Nerve blocks may cut opioid use after Open-Heart surgery

NCT ID NCT04985500

Symptom relief Sponsor: Icahn School of Medicine at Mount Sinai 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This study compares two types of nerve blocks—erector spinae plane (ESP) block and pecto-intercostal fascial (PIF) block—against standard care for controlling pain after heart surgery through the breastbone. About 225 adults aged 18–85 having planned cardiac surgery with a sternotomy will be randomly assigned to receive one of the blocks or no block. The main goal is to see if the blocks reduce opioid painkiller use and pain scores in the first 72 hours after surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
bupivacaine
What this could lead to
If successful, these nerve blocks could become a standard way to control pain after heart surgery, reducing the need for opioids.
What could go wrong
This is an early-phase trial with a modest number of participants. The blocks may not provide significant pain relief over standard care, and there is a small risk of local anesthetic toxicity.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

225 people

The number who actually took part.

Started

Jul 2021

Expected to finish

Dec 2026

An estimate. End dates often move.

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 to 85 years

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: * Adults 18-85 years old * Scheduled to undergo cardiac procedures involving sternotomy * All genders Exclusion Criteria: * ASA class V * Urgent or emergent surgery * Contraindications to administration of local anesthesia (e.g. local anesthetic allergy) * History of substance abuse or chronic opioid use * Patient refusal or inability to consent

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As listed by the trial registrant

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

Cardiac surgery Sternotomy

Contacts and locations

Locations

  • Mount Sinai Morningside Hospital

    New York, New York, 10025, United States

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