CompletedNot Applicable

Naproxen and Lidocaine Gel Combination for Rib Fracture

Turkey (Türkiye)110 participantsStarted 2024-01-01

Plain-language summary

This study evaluates whether adding a topical gel containing naproxen and lidocaine to routine intravenous analgesic treatment improves pain relief in adults with isolated traumatic rib fractures presenting to the emergency department. Participants are randomly allocated to receive either standard intravenous dexketoprofen alone or dexketoprofen combined with topical naproxen-lidocaine gel. Pain intensity is measured repeatedly during the first hour after treatment using the Numerical Rating Scale (NRS). The study also examines the need for additional rescue analgesia and monitors treatment-related adverse events to determine the effectiveness and safety of this multimodal analgesic strategy.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Comparison of the decreases in Numerical Rating Scale pain scores between two arms

Timeframe: 0, 15, 30, 60.minutes and intervals between these time frames

Trial details

NCT IDNCT07706036

SponsorAnkara City Hospital Bilkent

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-01

View on ClinicalTrials.gov More Thorax; Fracture trials