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临床试验/NCT07706036
NCT07706036已完成不适用

Analgesic Efficacy of a Naproxen and Lidocaine Gel Combination in Patients With Traumatic Rib Fractures: A Randomized Controlled Trial

Ankara City Hospital Bilkent1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2024年1月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
110
试验地点
1
主要终点
Comparison of the decreases in NRS pain scores between two arms

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Comparison of the decreases in NRS pain scores between two arms

时间窗: 0, 15, 30, 60.minutes and intervals between these time frames

Comparison of the absolute and relative (in percentage) changes in pain scores over time intervals

Comparison of the decreases in Numerical Rating Scale pain scores between two arms

时间窗: 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.

次要结局

  • Rate of the rescue analgesia need(60.minute)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alp Şener

Associate Professor

Ankara Yildirim Beyazıt University

研究点 (1)

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