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New pain block could cut opioid use in Kids' heart surgery

NCT ID NCT04577690

Symptom relief Sponsor: The Hospital for Sick Children Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 tests whether a pectoral nerve block (PECS) given before surgery can lower pain and the need for morphine after a heart device implant in children aged 3 to 18. Half the children will get the nerve block plus standard wound numbing, while the other half get only wound numbing. The goal is to see if the nerve block leads to less opioid use and better pain control after the procedure.

What this could mean

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

Active substance
bupivacaine with epinephrine
What this could lead to
If it works, this could provide a better way to manage pain after heart device surgery in children, reducing the need for strong painkillers like morphine.
What could go wrong
This is a small Phase 4 trial with only 48 participants, so results may not apply to all children. The nerve block itself carries rare risks like bleeding or infection.

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

About 48 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2019

Expected to finish

Jan 2028

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

3 to 18 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: • All patients 3-18 years undergoing CIED surgery in the chest Exclusion Criteria: * Children \< 3 years of age at time of procedure as bupivacaine is not licensed for this age group. * No parental or patient consent * Allergy to bupivacaine * Pregnancy or lactation * Any condition or diagnosis, that could in the opinion of the Principal Investigator or delegate interfere with the participant's ability to comply with study instructions, might confound the interpretation of the study results, or put the participant at risk.

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Conditions

The condition(s) this trial relates to.

Pain, Postoperative primary interstitial lung disease specific to childhood

As listed by the trial registrant

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

Adolescent Child Pain, postoperative

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospital for Sick Children

    RECRUITING

    Toronto, Ontario, M5G 1X8, Canada

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