2025-524889-25-00招募中2 期
Preventive effect of 5% lidocaine patch on the development of neuropathic pain following an osteoporotic vertebral fracture: A proof-of-concept, controlled, randomized trial
University Hospital Of Clermont-Ferrand3 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年5月1日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 3
研究概览
简要总结
Assess the development of neuropathic pain following an osteoporotic vertebral fracture 2 months after applying a daily 5% lidocaine patch.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patient (male or female) aged 50 or over, diagnosed with osteoporosis by a rheumatologist
- •Patient with osteoporotic vertebral fracture, as determined by the investigator, less than 1 month old
- •Patient with pain rated ≥3 on the numerical scale at the site of the vertebral fracture
- •Able to give informed consent to participate in the research.
- •Affiliation with a Social Security scheme.
排除标准
- •Patients with medical and/or surgical histories deemed by the investigator or his/her representative to be incompatible with the trial.
- •Known hypersensitivity to the active substance or to any of the excipients listed in the Composition section.
- •Known hypersensitivity to other local anesthetics of the amide type, such as bupivacaine, etidocaine, mepivacaine, and prilocaine.
- •Taking class I antiarrhythmic drugs (e.g., tocaine, mexiletine) or other local anesthetics.
- •Inflamed or damaged skin, such as active shingles lesions, dermatitis, or wounds at the site where the patch is applied.
- •Pregnant and breastfeeding women (A pregnancy test will be performed for women of childbearing age in accordance with CTCG guidelines (see APPENDIX X). The investigator will ensure that effective contraception is used while the lidocaine patch is being used.
- •Patient currently participating in another clinical research protocol.
- •Patient under legal protection or deprived of liberty.
- •Refusal to participate.
研究组 & 干预措施
VERSATIS 700 mg, emplâtre médicamenteux
Test
干预措施: VERSATIS 700 mg, emplâtre médicamenteux (Drug)
研究者
Lise Laclautre
Scientific
University Hospital Of Clermont-Ferrand
研究点 (3)
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