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New pain jab could cut opioid use in kids after surgery

NCT ID NCT06344091

Symptom relief Sponsor: Jiangsu HengRui Medicine Co., Ltd. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at a painkiller called bupivacaine liposome injection, given during surgery to help control pain afterward. It involves 232 children aged 6 to 17 having orthopedic (bone) surgery. The goal is to see if it safely reduces pain and the need for stronger opioid pain medicines.

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 232 people

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

Started

May 2024

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

6 to 17 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. Subjects and guardians are willing to sign the informed consent. 2. Subjects undergoing orthopedic surgery under general anesthesia with expected cumulative incision length≥3cm. 3. 6 years old ≤ age ≤17 years old , Male or female. 4. ASA Physical Status Classification I-III. Exclusion Criteria: 1. Subjects received liposomal bupivacaine or bupivacaine hydrochloride within the past 30 days; 2. Subjects with a history of immunodeficiency diseases (such as congenital immunodeficiency disease, AIDS or malignant tumors) or received immunosuppressants within 30 days; 3. Subjects with comorbid mental diseases (such as schizophrenia, depression, etc.) or difficult to communicate; 4. Subjects with a history of chronic pain or visceral pain; 5. Subjects with abnormal liver and kidney function; 6. Subjects with clinically significant abnormal heart rate or rhythm; 7. Subjects who are participating or planning to participate in any interventional clinical trial; 8. The investigators determined that other conditions were inappropriate for participation in this clinical trial.

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As listed by the trial registrant

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

Local analgesia via infiltration

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

  • Guangzhou Women and Children's Medical Center

    RECRUITING

    Guangzhou, Guangdong, 510000, China

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