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A shot that might dull post-surgery pain and cut opioid use in teens

NCT ID NCT05898087

Symptom relief Sponsor: Connecticut Children's Medical Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 31, 2026 · Last updated Jul 31, 2026

Summary

This trial tests whether injecting a local anesthetic called bupivacaine under the chest muscle during breast reduction surgery can lower pain and reduce the need for narcotic painkillers afterward. About 52 female patients aged 13 to 25 will be randomly assigned to receive either the numbing drug or a saline placebo during surgery. Participants will track their pain and medication use at home for a week, and researchers will compare pain scores and narcotic use between the two groups.

What this could mean

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

Active substance
bupivacaine (Marcaine) 0.25% injectable solution
What this could lead to
If effective, this could offer a simple way to reduce post-surgical pain and reliance on narcotics for teens undergoing breast reduction.
What could go wrong
The trial is small and early, and results may not apply broadly. There is also a chance the numbing injection provides no added benefit over standard care.

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

52 people

The number who actually took part.

Started

Apr 2022

Finished

May 2026

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

13 to 25 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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. Female 2. Age 13-25 at the time of surgery 3. Undergoing bilateral reduction mammaplasty at Connecticut Children's from 1/1/2022-12/31/2025. 4. Ability of child's parent/legal guardian to understand and the willingness to sign a written informed consent document. Exclusion Criteria: 1. Patients with history of substance use disorder or "chronic pain" defined as pain requiring management and treatment by a pain management specialist. 2. Patients already taking narcotics at the time of surgery. 3. Patients with a history of hepatic or renal dysfunction. 4. Patients with known allergy to bupivacaine. 5. Patients who are pregnant, determined by urine testing in pre-operative area. 6. Patients who are non-verbal or have developmental delays that would result in inability to report reliable pain scores. 7. Patients with significant post-operative complications 8. Patients not meeting inclusion criteria. 9. Patients lost to follow-up- they must be seen within 1 week and 4 weeks post-operatively

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Conditions

The condition(s) this trial relates to.

familial juvenile hypertrophy of the breast hypertrophy of breast Pain, Postoperative

As listed by the trial registrant

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

Macromastia Post operative pain

Contacts and locations

Locations

  • Connecticut Children's

    Farmington, Connecticut, 06032, United States

  • Connecticut Children's

    Hartford, Connecticut, 06106, United States

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