Esketamine Combined With PRF for Trigeminal Postherpetic Neuralgia

Capital Medical University

Status: Not yet enrolling

Conditions: Postherpetic; Neuralgia, Trigeminal (Etiology)

Treatments: Drug: control group; Drug: esketamine group

Study type: Interventional

Funder types: Other

Identifiers

NCT06914180

KY-2024-332-02-03

Details and patient eligibility

About

This trial's primary objective is to compare the analgesic efficacy of esketamine in combination with pulsed radiofrequency (PRF) against that of PRF monotherapy in patients with trigeminal postherpetic neuralgia (TPHN).

Full description

This study aims to determine whether the addition of esketamine to the PRF regimen can relieve pain in TPHN patients. By doing so, the research endeavors to identify a rapid, effective, and safe treatment approach for refractory TPHN patients

Enrollment: 174 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 the trigeminal nerve or its branches innervated regions；
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 gasserian ganglion(GG).

Exclusion criteria

1. Obstructive sleep apnoea syndrome;
2. Those who receive other more invasive treatments, such as radiofrequency thermocoagulation (RFT) of GG.
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

---

174 participants in 2 patient groups, including a placebo group

esketamine group

Experimental group

Description:

In addition to receiving PRF treatment+pregabalin, patients will also undergo a single intravenous infusion of esketamine

Treatment:

Drug: esketamine group

control group

Placebo Comparator group

Description:

patients will receive PRF treatment+pregabalin

Treatment:

Drug: control group