Effect of Intravenous Infusion of Esketamine Combined Pulsed Radiofrequency on Acute/Subacute Zoster-associated Trigeminal Neuralgia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- the NRS score at 1 month after treatment.
研究概览
简要总结
To assess the 1-month effects and safety of esketamine combined PRF and standardized treatment to relieve pain in patients with acute/subacute zoster-related trigeminal neuralgia(ZRTN).
详细描述
The investigators aim to investigate whether or not esketamine combined PRF and standardized treatment to relieve pain in patients with acute/subacute ZRTN , and seek a safe, and effective treatment for refractory patients with ZRTN
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
- •Age >18 years;
- •History of HZ within the last three months;
- •Lesions located in the trigeminal nerve or its branches innervated regions；
- •Numeric Rating Scale (NRS) pain score≥4 (NRS, 0 = no pain, 10= worst possible pain) with pharmacotherapy;
- •Planned to perform CT-guided PRF treatment of the Gasserian ganglion .
排除标准
- •Obstructive sleep apnoea syndrome;
- •Those who receive other invasive treatments, such as spinal cord stimulation;
- •A history of systemic immune diseases, organ transplantation, or cancers;
- •A history of severe cardiopulmonary, hepatic or renal dysfunction;
- •A history of schizophrenia, epilepsy, or myasthenia gravis, delirium;
- •Comorbid hyperthyroidism or phaeochromocytoma;
- •Recent history of drug abuse;
- •Having contraindications to esketamine;
- •Communication difficulties.
- •Withdrawal criteria
- •Lost to follow-up during the study;
- •Not perform the planned operation;
- •Receiving other treatment regimes during the study period;
- •Not suitable for continuing the study for emerging severe comorbidities or special physiological changes during the study;
- •Voluntary withdrawal from the study.
研究组 & 干预措施
Esketamine group
Besides PRF plus standardized treatment, patients will also receive intravenous infusion of Esketamine ;
干预措施: Esketamine group (Drug)
control group
Patients will only receive PRF plus standardized treatment
干预措施: PRF group (Drug)
结局指标
主要结局
the NRS score at 1 month after treatment.
时间窗: 1-month 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
- the 12-item Short-Form Health Survey (SF-12) score(at 1 day, 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment)
- the Pittsburgh Sleep Quality Index (PSQI) score(at 1 day, 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment)
- the Patient Global Impression of Change scale (PGIC)(at 1 day, 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment)
- Analgesics consumption(at 1 day, 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment)
- Safety assessments(at 0 day, 1 day, 1 week, 2 weeks,1 month, 2 months, 3 months)
研究者
Fang Luo
Director of Department of Day surgery and Pain Management Affiliation
Beijing Tiantan Hospital