Intravenous Infusion of Esketamine in Combination With Pulsed Radiofrequency of Dorsal Root Ganglion for Postherpetic Neuralgia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 186
- 试验地点
- 1
- 主要终点
- The primary comparison is the difference between the means of the daily mean pain scores over the first 7 days, measured on an 11-point NRS
研究概览
简要总结
This trial's primary objective is to compare the analgesic efficacy of esketamine in combination with pulsed radiofrequency (PRF) of dorsal root ganglion(DRG) against that of PRF monotherapy in patients with postherpetic neuralgia(PHN).
详细描述
This study aims to determine whether the addition of esketamine to the PRF of DRG regimen can relieve pain in PHN patients. By doing so, the research endeavors to identify a rapid, effective, and safe treatment approach for refractory PHN patients
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
- Single (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
- 否
入选标准
- •Ages more than 18 years;
- •Pain persisting for over three months following the onset of the herpes zoster skin rash;
- •Lesions located in in the unilateral cervical, thoracic, and lumbosacral segments;
- •Having an average pain score of at least 4 on a Numeric Rating Scale (NRS, 0 = no pain, 10= worst possible pain)； Planned to perform CT-guided PRF treatment of the Dorsal root ganglion（DRG）
排除标准
- •Obstructive sleep apnoea syndrome;
- •Those who receive other more invasive treatments, such as radiofrequency thermocoagulation (RFT) of DRG.
- •A history of systemic immune diseases, organ transplantation, or cancers;
- •A history of severe cardiopulmonary, hepatic, renal dysfunction or coagulation function disorder;
- •A history of schizophrenia, epilepsy, or myasthenia gravis, delirium;
- •Comorbid hyperthyroidism or phaeochromocytoma;
- •Recent history of drug abuse;
- •Having contraindications to esketamine;
- •Communication difficulties.
- •Women who are preparing for pregnancy, in the pregnancy or lactation period.
研究组 & 干预措施
esketamine group
esketamine+PRF group
干预措施: esketamine+PRF treatment group (Drug)
control group
PRF group
干预措施: PRF treatment group (Drug)
结局指标
主要结局
The primary comparison is the difference between the means of the daily mean pain scores over the first 7 days, measured on an 11-point NRS
时间窗: 7-day period
The Numeric Rating Scale (NRS) score is a way to quantify the degree of subjective feelings such as pain using numbers. Generally, 0 represents no pain, and 10 represents the most severe pain.A higher score indicates more severe pain
次要结局
- average weekly NRS score(up to 12 weeks)
- Averaged weekly analgesic consumption(up to 12 weeks)
- the 12-item Short-Form Health Survey (SF-12) score(At the end of weeks1, 2, 4, 8, and 12 after treatment)
- the Pittsburgh Sleep Quality Index (PSQI) score(At the end of weeks 1,2, 4, 8, and 12 after treatment)
- the Patient Global Impression of Change scale (PGIC)(At the end of weeks 1,2 4, 8, and 12 after treatment)
- The Hospital Anxiety and Depression Scale (HADS)(At the end of weeks 1, 2, 4, 8, and 12 after treatment)
- Safety assessments(Conducted on Day 0, Day 1, Day 3, and at the end of weeks 1, 2, 4, 8, and 12 after treatment)
- success rate(At the end of weeks 1, 2, 4, 8, and 12 after treatment)
研究者
Fang Luo
Director of Department of Day surgery and Pain Management
Beijing Tiantan Hospital