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New scalp injection could ease pain after brain surgery

NCT ID NCT05624359

Symptom relief Sponsor: Beijing Tiantan Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Updated 1 time

Summary

This study tests whether adding flurbiprofen axetil to a standard numbing medicine (ropivacaine) injected into the scalp before brain surgery can reduce pain afterward. About 216 adults having brain surgery will be randomly assigned to receive either the combination or the numbing medicine alone. The main goal is to see if the combination lowers the need for additional pain medicine through a patient-controlled pump over 48 hours.

What this could mean

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

Active substance
flurbiprofen axetil plus ropivacaine
What this could lead to
If it works, this could offer a better way to manage pain after brain surgery, reducing the need for strong opioids.
What could go wrong
This is a small, suspended early-phase trial. The added benefit over standard care may be small, and results may not apply to all 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

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.

Participants

About 216 people

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

Started

Nov 2023

Expected to finish

Mar 2026

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 64 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. Age minimum 18 years; 2. ASA physical status of I - II; 3. Body mass index (BMI) of 15 - 30; 4. Scheduled for supratentorial craniotomy under general anesthesia; 5. Anticipated tracheal extubation, recovery of consciousness and orientation within 2 hours after craniotomy. Exclusion Criteria: 1. Glasgow Coma Scale \<15; 2. Unable to use the PCIA device or comprehend the pain NRS; 3. History of opioid dependence, chronic headache or intake of any drugs with known analgesic properties within the 24 hours before surgery; 4. History of craniotomy or scalp infection; 5. Any contraindication to flurbiprofen axetil, such as gastrointestinal ulcer, coagulation disorders, renal dysfunction, heart failure and ischemic heart disease; 6. History of allergy to any drug used in the study; 7. Pregnancy and breastfeeding.

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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.

Postoperative pain

How to take part

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  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.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Beijing Tiantan Hospital

    Beijing, China

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