Esketamine Combined With PRF of DRG for Acute/Subacute Zoster-associated Pain

Официальное название

Esketamine Intravenous Infusion Combined With Pulsed Radiofrequency of Dorsal Root Ganglion for Acute and Subacute Herpes Zoster Neuralgia: A Randomized Controlled Trial

Обзор

To assess the 1-month effects and safety of esketamine - PRF -standardized drug treatment against PRF -standardized drug treatment acute/subacute zoster-associated pain (ZAP) patients.

Подробное описание

This study aims to determine whether the addition of esketamine to PRF - standardized drug treatment can improve 1 - month pain control and safety profiles in acute/subacute ZAP patients. The findings may help optimize current treatment strategies for refractory ZAP patients.

Вмешательства

• Препарат esketamine group
  in addition to receiving the combination of PRF of DRG and standardized drug treatment, patients will also undergo a single intravenous infusion of esketamine.
• Препарат PRF group
  In the control group, patients will receive PRF+standardized drug treatment. Pulsed radiofrequency (PRF) will be performed on DRG by an designated physician in each participating center. They will be treated with PRF (PMG-230, Baylis Medical Inc.) using a 21-gauge sterilized radiofrequency needle (a 10-cm trocar with a 5-mm active tip, PMF-21-100-5, Baylis Medical Inc.), which are carefully inserted until the needle tip reaches the upper edge of the intervertebral foramen. The parameters of PRF

Первичные конечные точки

• the NRS score at 1 month after treatment. [Срок оценки: 1-month period]

Вторичные конечные точки (7)

• the NRS score after treatment [Срок оценки: at 1 week, 2 weeks, 2 months, 3 months after treatment]
• the 12-item Short-Form Health Survey (SF-12) score [Срок оценки: at 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment]
• the Pittsburgh Sleep Quality Index (PSQI) score [Срок оценки: at 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment]
• The Patient Global Impression of Change scale (PGIC) [Срок оценки: at 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment]
• Analgesics consumption [Срок оценки: at 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment]
• Safety assessments [Срок оценки: at 0 day, 1 day, 1 week, 2 weeks,1 month, 2 months, 3 months]
• success rate [Срок оценки: at 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment]

Критерии участия

Критерии включения

• Ages more than 18 years;
• Patients with onset of herpes zoster (HZ) rash less than 90 days;
• HZ affected the spinal nerves (cervical/thoracic/lumbar nerve);
• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Beijing Tiantan Hospital — Пекин

Идентификаторы

NCT: NCT06914206 · KY-2024-332-02-04

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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