Clinical trial NCT06914206: Esketamine Combined With PRF of DRG for Acute/Subacute Zoster-associated Pain
Official title: Esketamine Intravenous Infusion Combined With Pulsed Radiofrequency of Dorsal Root Ganglion for Acute and Subacute Herpes Zoster Neuralgia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Herpes Zoster
Keywords: Herpes Zoster Neuralgia
Esketamine
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Xiaotangshan Hospital
name: The First Hospital of Fangshan District,Beijing
name: Beijing Ditan Hospital
name: Hengshui People's Hospital
First posted: 2025-04-06
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Ages more than 18 years;
2. Patients with onset of herpes zoster (HZ) rash less than 90 days;
3. HZ affected the spinal nerves (cervical/thoracic/lumbar nerve);
4. Having an average pain score of at least 4 on a Numeric Rating Scale (NRS, 0 = no pain, 10= worst possible pain)；
5. Planned to perform CT-guided PRF treatment of the dorsal root ganglion(DRG).

Exclusion Criteria:

1. Obstructive sleep apnoea syndrome;
2. Those who receive other more invasive treatments, such as radiofrequency thermocoagulation (RFT) of DRG.
3. A history of systemic immune diseases, organ transplantation, or cancers;
4. A history of severe cardiopulmonary, hepatic, renal dysfunction or coagulation function disorder;
5. A history of schizophrenia, epilepsy, or myasthenia gravis, delirium;
6. Comorbid hyperthyroidism or phaeochromocytoma;
7. Recent history of drug abuse;
8. Having contraindications to esketamine;
9. Communication difficulties.
10. Women who are preparing for pregnancy, in the pregnancy or lactation period.

Primary outcomes:
measure: the NRS score at 1 month after treatment.
timeFrame: 1-month period
Secondary outcomes:
measure: the NRS score after treatment
timeFrame: at 1 week, 2 weeks, 2 months, 3 months after treatment
measure: the 12-item Short-Form Health Survey (SF-12) score
timeFrame: at 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment
measure: the Pittsburgh Sleep Quality Index (PSQI) score
timeFrame: at 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment
measure: The Patient Global Impression of Change scale (PGIC)
timeFrame: at 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment
measure: Analgesics consumption
timeFrame: at 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment
measure: Safety assessments
timeFrame: at 0 day, 1 day, 1 week, 2 weeks,1 month, 2 months, 3 months
measure: success rate
timeFrame: at 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
Study officials:
References: