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Completed
NCT07706036
Naproxen and Lidocaine Gel Combination for Rib Fracture
Conditions: Thorax; Fracture, Rib Fracture, Pain Management
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 110
Sponsor: Ankara City Hospital Bilkent
Location: Ankara Bilkent City Hospital; Department of Emergency Medicine Ankara Çankaya
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07706036). StuddyBuddy aggregates publicly available trial information.