Naproxen and Lidocaine Gel Combination for Rib Fracture

Ankara City Hospital

Status: Completed

Conditions: Rib Fracture; Pain Management; Thorax; Fracture

Treatments: Drug: Dexketoprofen trometamol 50 mg IV; Drug: A gel combination containing 10% naproxen and 5% lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT07706036

E-86241737-100--320605

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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110 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

Drug: A gel combination containing 10% naproxen and 5% lidocaine

Drug: Dexketoprofen trometamol 50 mg IV

Control

Active Comparator group

Description:

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.

Treatment:

Drug: Dexketoprofen trometamol 50 mg IV