Pain Management, Rib Fracture, Thorax; Fracture
Conditions
Keywords
Pain, Rib Fracture, Naproxen, Lidocaine, Gel, Numerical Rating Scale
Brief 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.
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.
Interventions
DRUGA gel combination containing 10% naproxen and 5% lidocaine
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
DRUGDexketoprofen trometamol 50 mg IV
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
Sponsors
Ankara City Hospital Bilkent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the decreases in Numerical Rating Scale pain scores between two arms | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of the rescue analgesia need | 60.minute | Comparison of the rate of the rescue analgesia need between two arms |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORAlp Şener, Assoc Prof
Ankara Yildirim Beyazıt University
Outcome results
None listed