Thorax; FractureNCT07706036
Naproxen and Lidocaine Gel Combination for Rib Fracture
A study testing A gel combination containing 10% naproxen and 5% lidocaine and Dexketoprofen trometamol 50 mg IV in people with Thorax; Fracture and Rib Fracture, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thorax; Fracture, Rib Fracture, Pain Management
- What is being tested?
- A gel combination containing 10% naproxen and 5% lidocaine and Dexketoprofen trometamol 50 mg IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 2 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital; Department of Emergency Medicine
Ankara, Çankaya, 06800
About this study
Official title: Analgesic Efficacy of a Naproxen and Lidocaine Gel Combination in Patients With Traumatic Rib Fractures: A Randomized Controlled Trial
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.
Read the detailed description
Pain caused by rib fractures frequently limits deep inspiration and coughing, potentially increasing the risk of respiratory complications. Although systemic analgesics remain the standard approach in the emergency department, combining medications with different mechanisms of action may provide superior pain control while reducing the need for additional analgesics. The present trial investigates whether topical administration of a naproxen-lidocaine gel offers additional analgesic benefit when used alongside routine intravenous NSAID therapy.
This investigation is designed as a prospective, randomized, controlled clinical trial conducted at a tertiary emergency department. Adults diagnosed with isolated rib fractures who meet predefined eligibility criteria are enrolled and randomly assigned to one of two treatment strategies. All participants receive intravenous dexketoprofen as standard care. Patients allocated to the intervention arm additionally receive topical application of a gel formulation containing naproxen and lidocaine over the painful rib fracture region, whereas the comparison group receives standard therapy alone.
Pain severity is evaluated using the Numerical Rating Scale before treatment and at predefined follow-up intervals during the first 60 minutes. The principal outcome is the magnitude of pain reduction achieved with each treatment strategy. Secondary outcome measures include the proportion of patients requiring rescue analgesic medication and the frequency of treatment-related adverse events. Statistical comparisons are planned to determine whether adjunctive topical therapy provides clinically meaningful improvements in early pain management for isolated traumatic rib fractures.
- Conditions
- Thorax; Fracture, Rib Fracture, Pain Management
- Being tested
- A gel combination containing 10% naproxen and 5% lidocaine, Dexketoprofen trometamol 50 mg IV
- Keywords
- Pain, Rib Fracture, Naproxen, Lidocaine, Gel, Numerical Rating Scale
- Medical subject headings
- Fractures, Bone, Rib Fractures, Agnosia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A gel combination containing 10% naproxen and 5% lidocaineDrug
Approximately 10 grams of a gel combination containing 10% naproxen and 5% lidocaine to the rib fracture site, covering both the upper and lower ribs
Dexketoprofen trometamol 50 mg IVDrug
Dexketoprofen at a dose of 50 mg, dissolved in 150 ml of 0.9% NaCl solution and administered intravenously via rapid infusion over 15 minutes
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Received the standard treatment of a pain reliever containing the active ingredient dexketoprofen at a dose of 50 mg, dissolved in 150 ml of 0.9% NaCl solution and administered intravenously via rapid infusion over 15 minutes. In addition, the intervention group received a topical application of approximately 10 grams of a gel combination containing 10% naproxen and 5% lidocaine to the rib fracture site. Receives: Drug: A gel combination containing 10% naproxen and 5% lidocaine; Drug: Dexketoprofen trometamol 50 mg IV |
| Control | Active comparator | Received the standard treatment of a pain reliever containing the active ingredient dexketoprofen at a dose of 50 mg, dissolved in 150 ml of 0.9% NaCl solution and administered intravenously via rapid infusion over 15 minutes. Receives: Drug: Dexketoprofen trometamol 50 mg IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the decreases in Numerical Rating Scale pain scores between two arms
Comparison of the absolute and relative (in percentage) changes in Numerical Rating Scale pain scores over time intervals. The Numerical Rating Scale is a score ranging from 0 to 10, where 0 indicates the lowest level of pain and 10 indicates the highest level of pain.
Measured: 0, 15, 30, 60.minutes and intervals between these time frames
Secondary outcomes (1)
Rate of the rescue analgesia need
Comparison of the rate of the rescue analgesia need between two arms
Measured: 60.minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start1 Jan 2024
- Primary completion1 Jul 2024
- Study completion2 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thorax; FractureStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alp Şener, Ankara Yildirim Beyazıt University
- Investigators
- Alp Şener, Assoc Prof, Principal investigator, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07706036
- Sponsor's protocol ID
- E-86241737-100--320605
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data collected during this study will not be made publicly available. Requests for de-identified individual participant data may be considered by the corresponding author on a reasonable case-by-case basis, subject to ethical, legal, and institutional requirements.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of a Naproxen and Lidocaine Gel Combination in Patients With Traumatic Rib Fractures: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07706036
- Acronym / sponsor ID
- E-86241737-100--320605
- Conditions
- Thorax; Fracture, Rib Fracture, Pain Management
- Keywords
- Pain, Rib Fracture, Naproxen, Lidocaine, Gel, Numerical Rating Scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 2 Jul 2024 (actual)
- First posted
- 15 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Pain caused by rib fractures frequently limits deep inspiration and coughing, potentially increasing the risk of respiratory complications. Although systemic analgesics remain the standard approach in the emergency department, combining medications with different mechanisms of action may provide superior pain control while reducing the need for additional analgesics. The present trial investigates whether topical administration of a naproxen-lidocaine gel offers additional analgesic benefit when used alongside routine intravenous NSAID therapy.
This investigation is designed as a prospective, randomized, controlled clinical trial conducted at a tertiary emergency department. Adults diagnosed with isolated rib fractures who meet predefined eligibility criteria are enrolled and randomly assigned to one of two treatment strategies. All participants receive intravenous dexketoprofen as standard care. Patients allocated to the intervention arm additionally receive topical application of a gel formulation containing naproxen and lidocaine over the painful rib fracture region, whereas the comparison group receives standard therapy alone.
Pain severity is evaluated using the Numerical Rating Scale before treatment and at predefined follow-up intervals during the first 60 minutes. The principal outcome is the magnitude of pain reduction achieved with each treatment strategy. Secondary outcome measures include the proportion of patients requiring rescue analgesic medication and the frequency of treatment-related adverse events. Statistical comparisons are planned to determine whether adjunctive topical therapy provides clinically meaningful improvements in early pain management for isolated traumatic rib fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: A gel combination containing 10% naproxen and 5% lidocaine, Drug: Dexketoprofen trometamol 50 mg IVReceived the standard treatment of a pain reliever containing the active ingredient dexketoprofen at a dose of 50 mg, dissolved in 150 ml of 0.9% NaCl solution and administered intravenously via rapid infusion over 15 minutes. In addition, the intervention group received a topical application of approximately 10 grams of a gel combination containing 10% naproxen and 5% lidocaine to the rib fracture site. |
| Control | Active comparator | Drug: Dexketoprofen trometamol 50 mg IVReceived the standard treatment of a pain reliever containing the active ingredient dexketoprofen at a dose of 50 mg, dissolved in 150 ml of 0.9% NaCl solution and administered intravenously via rapid infusion over 15 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A gel combination containing 10% naproxen and 5% lidocaineApproximately 10 grams of a gel combination containing 10% naproxen and 5% lidocaine to the rib fracture site, covering both the upper and lower ribs | Drug | Intervention |
| Dexketoprofen trometamol 50 mg IVDexketoprofen at a dose of 50 mg, dissolved in 150 ml of 0.9% NaCl solution and administered intravenously via rapid infusion over 15 minutes | Drug | Control, Intervention |
Primary outcome
Comparison of the decreases in Numerical Rating Scale pain scores between two arms
Time frame: 0, 15, 30, 60.minutes and intervals between these time frames
Comparison of the absolute and relative (in percentage) changes in Numerical Rating Scale pain scores over time intervals. The Numerical Rating Scale is a score ranging from 0 to 10, where 0 indicates the lowest level of pain and 10 indicates the highest level of pain.
1 secondary outcome
Rate of the rescue analgesia need
Time frame: 60.minute
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data collected during this study will not be made publicly available. Requests for de-identified individual participant data may be considered by the corresponding author on a reasonable case-by-case basis, subject to ethical, legal, and institutional requirements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alp Şener, Assoc Prof principal investigator
Ankara Yildirim Beyazıt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A gel combination containing 10% naproxen and 5% lidocaine and Dexketoprofen trometamol 50 mg IV in people with Thorax; Fracture and Rib Fracture, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the decreases in Numerical Rating Scale pain scores between two arms (time frame: 0, 15, 30, 60.minutes and intervals between these time frames). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.