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New combo shot aims to stop severe pain after surgery

NCT ID NCT07606911

Symptom relief Sponsor: Shanghai Jiao Tong University Affiliated Sixth People'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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 03, 2026 · Updated 3 times

Summary

This study tests whether adding a long-acting form of bupivacaine to the standard painkiller can prevent the sudden severe pain that often occurs when a nerve block wears off after orthopedic surgery. Researchers will compare the combination against the standard painkiller alone in 668 adults undergoing arm or leg surgery. The goal is to see if the combo reduces the number of patients who experience a sharp jump in pain within the first 24 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
liposomal bupivacaine combined with plain bupivacaine
What this could lead to
If it works, this could offer a better way to manage pain after orthopedic surgery, reducing the sudden severe pain that can occur when a nerve block wears off.
What could go wrong
This is a phase 4 trial, so the drugs are already approved, but the specific combination may not prove more effective than standard care. Results may not apply to all surgeries or patients.

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 668 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

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 65 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: * 18-65 years old; * ASA Physical Status 1-3; * Scheduled for elective unilateral orthopedic surgery of the upper or lower extremity. Exclusion Criteria: * Women who are pregnant or breastfeeding; * Bupivacaine sensitivity or known allergy; * Contraindication for nerve blocks; * Enrollment in another clinical trial that could confound pain evaluation; * Other conditions that preclude study participation.

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Conditions

The condition(s) this trial relates to.

Acute Pain

As listed by the trial registrant

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

Acute pain Orthopaedic surgery

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

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Shanghai sixth people's hospital

    Shanghai, Shanghai Municipality, 200233, China

More trials for these conditions

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