Assessing the Efficacy of High-Dose Lidocaine-Tetracaine Cream for the Treatment of Peripheral Neuropathic Pain: A Crossover Study in Elderly Patients Refractory to Pharmacological Treatments
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Reduction in pain (treatment area)
研究概览
简要总结
The goal of this clinical trial is to learn if the topical anesthetic cream works to treat neuropathic chronic pain in older adults who have not found sufficient relief undergoing other pain treatments and/or medications. The safety of this drug has already been tested in other studies. The main questions it aims to answer are:
- Does the anesthetic cream lower the pain of participants?
- Can the participants return to daily activities that they have quit due to chronic pain?
- What medical problems do participants have when using this cream?
Researchers will compare the anesthetic cream to a placebo (a look-alike substance that contains no drug) to see if it works to treat neuropathic chronic pain.
Participants will:
- Use the anesthetic cream or a placebo every day for 14 days
- Visit the clinic once every 2 weeks for checkups and tests
- Keep a diary of their symptoms and the number of times they use the anesthetic cream.
This study is divided into two phases, separated by 30 days.
- Phase 1: Application of the active cream (Lidocaine 23% / Tetracaine 7%) twice daily: once in the morning upon waking and once at night before bed.
- Phase 2: Application of the placebo cream under the exact same conditions.
The order of administration (active/placebo) will be randomly assigned.
Procedure: Participants will sign the informed consent form. A baseline evaluation will be conducted, assessing VAS (Visual Analog Scale) score, functionality, and quality of life.
The use of other medications will be recorded. The creams will be applied at home with weekly telephone follow-up and daily patient self-reporting. Evaluations will be conducted on day 14 of each phase. Follow-up controls will occur one and two months after the treatment is suspended. Adherence and adverse effects will also be logged.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 60 years or older.
- •Clinical diagnosis of peripheral neuropathic pain that has lasted for at least 6 months.
- •Baseline Visual Analog Scale (VAS) pain score of 6 or higher.
- •Ability to understand and sign the informed consent form.
排除标准
- •Known hypersensitivity (allergy) to lidocaine, tetracaine, or any excipients (inactive ingredients) in the preparation
- •Dermatological lesions (skin damage or sores) in the intended application area.
- •Concomitant use of other topical therapies (creams, gels, patches) in the affected area.
- •Severe cognitive impairment or unstable medical comorbidity.
研究组 & 干预措施
All Participants, placebo cream
In this crossover study, all the participants will take part as their own control group.
干预措施: Placebo cream application (Drug)
All participants, active cream
In this crossover study, all the participants will take part as their own control group.
干预措施: Lidocaine (23%) + Tetracaine (7%) (Drug)
结局指标
主要结局
Reduction in pain (treatment area)
时间窗: From Enrollment to the end of treatment at 2 months
The Visual Analog Pain Scale, will be used to assess the reduction of pain, being 0 no pain and 10 the worst pain ever experienced.
次要结局
- Better outcomes in daily function and quality of life(From enrollment to the end of treatment at 2 months)
- Better outcomes in daily function and quality of life(From enrollment to the end of treatment at 2 months.)