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

Capital Medical University

Status: Not yet enrolling

Conditions: Herpes Zoster

Treatments: Drug: esketamine group; Drug: PRF group

Study type: Interventional

Funder types: Other

Identifiers

NCT06914206

KY-2024-332-02-04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 184 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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184 participants in 2 patient groups

Esketamine group

Experimental group

Description:

Esketamine+ PRF group

Treatment:

Drug: esketamine group

control group

Active Comparator group

Description:

PRF group

Treatment:

Drug: PRF group