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Topical gel could ease rib fracture pain in the ER

NCT ID NCT07706036

Symptom relief Sponsor: Ankara City Hospital Bilkent Source: ClinicalTrials.gov ↗

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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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 15, 2026 · Last updated Jul 21, 2026 · Updated 3 times

Summary

This trial tests whether adding a topical gel containing naproxen and lidocaine to standard intravenous pain medication improves pain relief for adults with isolated rib fractures from blunt chest trauma. Participants receive either the standard IV painkiller alone or the IV painkiller plus a one-time application of the gel over the fractured area. Pain levels are tracked over the first hour, and the need for extra rescue pain medication is compared 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
a topical gel containing 10% naproxen and 5% lidocaine, applied once over the fractured rib area as an add-on to intravenous dexketoprofen
What this could lead to
If effective, this gel could offer a simple, non-invasive way to improve pain control for rib fracture patients in the emergency room, potentially reducing the need for stronger rescue painkillers.
What could go wrong
This is a small, early-stage trial with only 110 participants. The gel is applied just once, so its benefit may be limited or not significantly better than standard care alone.

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

110 people

The number who actually took part.

Started

Jan 2024

Finished

Jul 2024

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 years and older

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: * Adults aged 18 years or older. * Presentation to the emergency department following blunt chest trauma with isolated rib fracture(s) confirmed by clinical and/or radiological assessment. * A maximum of three fractured ribs. * In cases of multiple fractures, involvement of adjacent (consecutive) ribs only. * No associated intrathoracic injuries, including pneumothorax, hemothorax, pulmonary contusion, or other clinically significant thoracic trauma. * Fully conscious and able to communicate effectively, with adequate orientation and cooperation to complete pain assessments. * Baseline Numerical Rating Scale (NRS) pain score ≥4 at the time of enrollment. * Ability and willingness to provide written informed consent. Exclusion Criteria: * Pregnancy or suspected pregnancy. * Inability to reliably assess pain because of impaired consciousness, cognitive dysfunction, communication difficulties, or lack of cooperation. * Significant visual or hearing impairment interfering with study procedures. * Use of systemic analgesic medication within 6 hours before enrollment. * History of major psychiatric or neurological disorders that could influence pain perception or study participation. * Known hypersensitivity or previous adverse reaction to naproxen, lidocaine, dexketoprofen, tramadol hydrochloride, or any component of the study medications. * Presence of additional traumatic injuries requiring alternative pain management or hospital admission.

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Conditions

The condition(s) this trial relates to.

agnosia bone fracture Pain Rib Fractures

As listed by the trial registrant

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

Pain management Rib fracture Thorax; fracture

Contacts and locations

Locations

  • Ankara Bilkent City Hospital; Department of Emergency Medicine

    Ankara, Çankaya, 06800, Turkey (Türkiye)

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