Naproxen and Lidocaine Gel Combination for Rib Fracture

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.

Study Overview

• Status: Completed
• Conditions: Pain Management; Rib Fracture; Thorax; Fracture
• Intervention / Treatment: Drug: A gel combination containing 10% naproxen and 5% lidocaine; Drug: Dexketoprofen trometamol 50 mg IV

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 Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Çankaya
    • Ankara, Çankaya, Turkey (Türkiye), 06800
      • Ankara Bilkent City Hospital; Department of Emergency Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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.	Drug: A 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; Drug: Dexketoprofen 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
Active Comparator: Control; 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.	Drug: Dexketoprofen 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	0, 15, 30, 60.minutes and intervals between these time frames

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of the rescue analgesia need	Comparison of the rate of the rescue analgesia need between two arms	60.minute

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent
• Investigators: Principal Investigator: Alp Şener, Assoc Prof, Ankara Yildirim Beyazıt University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): July 1, 2024
• Study Completion (Actual): July 2, 2024

Study Registration Dates

• First Submitted: July 9, 2026
• First Submitted That Met QC Criteria: July 10, 2026
• First Posted (Actual): July 15, 2026

Study Record Updates

• Last Update Posted (Actual): July 20, 2026
• Last Update Submitted That Met QC Criteria: July 17, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Pain; Lidocaine; Naproxen; Gel; Rib Fracture; Numerical Rating Scale
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Wounds and Injuries; Neurobehavioral Manifestations; Thoracic Injuries; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Fractures, Bone; Agnosia; Rib Fractures; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Naphthaleneacetic Acids; Lidocaine; Naproxen; dexketoprofen trometamol
• Other Study ID Numbers: E-86241737-100--320605

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No