Naproxen and Lidocaine Gel Combination for Rib Fracture

NCT07706036 | Completed

• 1 other identifier: E-86241737-100--320605
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Thorax; Fracture; Rib Fracture; Pain Management

Keywords

Pain; Rib Fracture; Naproxen; Lidocaine; Gel; Numerical Rating Scale

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Rate of the rescue analgesia need

  60.minute

Study Arms (2)

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.

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.

Drug: Dexketoprofen trometamol 50 mg IV

Interventions

Dexketoprofen trometamol 50 mg IV DRUG

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

Control; Intervention

A gel combination containing 10% naproxen and 5% lidocaine DRUG

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital; Department of Emergency Medicine

Ankara, Çankaya, 06800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fractures, Bone; Rib Fractures; Agnosia; Pain

Interventions

Naproxen; Lidocaine; dexketoprofen trometamol

Condition Hierarchy (Ancestors)

Wounds and Injuries; Thoracic Injuries; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Study Officials

• Alp Şener, Assoc Prof

  Ankara Yildirim Beyazıt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 9, 2026
• First Posted: July 15, 2026
• Study Start: January 1, 2024
• Primary Completion: July 1, 2024
• Study Completion: July 2, 2024
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)