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Heart surgery pain study pulled before it began

NCT ID NCT04788056

Symptom relief Sponsor: Brigham and Women's Hospital 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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study aimed to see if a nerve block called a parasternal subpectoral plane block could reduce pain and the need for opioids after heart surgery. It planned to compare a numbing medicine (bupivacaine) to a saltwater placebo in about 100 adults having elective heart surgery. However, the study was withdrawn before enrolling any participants, so no results are available.

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 it had worked, this could have pointed toward a way to reduce pain and opioid use after heart surgery.
What could go wrong
The study was withdrawn before it started, so no results are available. Even if conducted, it was a small early-stage trial, and the nerve block might not have worked better than a placebo.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Expected to start

Jun 2021

An estimate. Start dates often move.

Expected to finish

Jun 2023

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 80 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: 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

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Conditions

The condition(s) this trial relates to.

Pain, Postoperative

As listed by the trial registrant

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

Pain, postoperative

More trials for these conditions

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