Esketamine Combined With PRF of DRG for Postherpetic Neuralgia

NCT ID: NCT06914193

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 186 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2026-10-01

Brief Summary

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).

Detailed 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

Conditions

Postherpetic Neuralgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

esketamine group

esketamine+PRF group

Group Type: EXPERIMENTAL

esketamine+PRF treatment group

Intervention Type: DRUG

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

control group

PRF group

Group Type: ACTIVE_COMPARATOR

PRF treatment group

Intervention Type: DRUG

In the control group, patients will receive PRF treatment. PRF will be performed on DRG by an designated physician in each participating center. The patients 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 will be carefully inserted until the needle tip reached the upper edge of the intervertebral foramen under the guidance of three-dimensional (3D) CT. PRF treatment (PMG-230, Baylis Medical Inc.) targeting to DRG will be applied for 900 seconds. The parameters of PRF treatment will be set at 42 ℃, 2 Hz with 20 milliseconds current. Regarding pregabalin, the dosage is titrated based on patients'pain intensity and tolerance. This process fully accounts for individual patient differences to optimize treatment outcomes.

Interventions

esketamine+PRF treatment group

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

Intervention Type: DRUG

PRF treatment group

In the control group, patients will receive PRF treatment. PRF will be performed on DRG by an designated physician in each participating center. The patients 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 will be carefully inserted until the needle tip reached the upper edge of the intervertebral foramen under the guidance of three-dimensional (3D) CT. PRF treatment (PMG-230, Baylis Medical Inc.) targeting to DRG will be applied for 900 seconds. The parameters of PRF treatment will be set at 42 ℃, 2 Hz with 20 milliseconds current. Regarding pregabalin, the dosage is titrated based on patients'pain intensity and tolerance. This process fully accounts for individual patient differences to optimize treatment outcomes.

Intervention Type: DRUG

Other Intervention Names

esketamine+PRF treatment+pregabalin; PRF treatment+pregabalin

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Xiaotangshan Hospital

OTHER

Sponsor Role: collaborator

The First Hospital of Fangshan District,Beijing

OTHER

Sponsor Role: collaborator

Beijing Ditan Hospital

OTHER

Sponsor Role: collaborator

Hengshui People's Hospital

OTHER

Sponsor Role: collaborator

Beijing Tiantan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Fang Luo

Director of Department of Day surgery and Pain Management

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Fang Luo

Role: CONTACT

13611326978@163.com

+86 13611326978

Other Identifiers

KY-2024-332-02-05

Identifier Type: -

Identifier Source: org_study_id