Esketamine Combined With PRF of DRG for Postherpetic Neuralgia

Capital Medical University

Status: Not yet enrolling

Conditions: Postherpetic Neuralgia

Treatments: Drug: PRF treatment group; Drug: esketamine+PRF treatment group

Study type: Interventional

Funder types: Other

Identifiers

NCT06914193

KY-2024-332-02-05

Details and patient eligibility

About

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).

Full description

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

Enrollment: 186 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Ages more than 18 years;
2. Pain persisting for over three months following the onset of the herpes zoster skin rash;
3. Lesions located in in the unilateral cervical, thoracic, and lumbosacral segments;
4. 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）

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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186 participants in 2 patient groups

esketamine group

Experimental group

Description:

esketamine+PRF group

Treatment:

Drug: esketamine+PRF treatment group

control group

Active Comparator group

Description:

PRF group

Treatment:

Drug: PRF treatment group