Esketamine Combined Pregabalin and Duloxetine for Postherpetic Neuralgia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2026-05-01

Brief Summary

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To assess the 1-week effects and safety of esketamine in combination with pregabalin and duloxetine to relieve pain in patients with postherpetic Neuralgia(PHN).

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Detailed Description

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The investigators aim to investigate whether or not esketamine combined with pregabalin and duloxetine to relieve pain in patients with PHN, and seek a rapid, effective and safe treatment for refractory patients with PHN

Conditions

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Postherpetic Neuralgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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the esketamine group

In the esketamine group, in addition to receiving the combination of pregabalin and duloxetine, patients will also undergo a single intravenous infusion of esketamine. A total of 0.5 mg/kg of esketamine will be diluted in 50 mL of normal saline. The infusion will commence with an intravenous injection of 10 mg of esketamine over 1 minute, followed by a maintenance dose of 8 mg/h. The infusion rate will be adjusted based on the patients' tolerance levels.

Group Type EXPERIMENTAL

esketamine group

Intervention Type DRUG

In the esketamine group, in addition to receiving the combination of pregabalin and duloxetine, patients will also undergo a single intravenous infusion of esketamine.

the control group

In the control group, patients will receive pregabaline combined with duloxetine. Pregabaline will be administered at a dose of 50-75 mg, twice daily during the first 3 days of treatment, and increase to 300mg daily after 3-7days, then by an additional 150mg daily every 3-7 days as tolerated, up to a maximum daily dose of 600mg. Meanwhile, duloxetine will be prescribed at an initial daily dose of 30mg, and then gradually increased to 60 mg daily after one week if patients tolerate it well.

Group Type PLACEBO_COMPARATOR

control group

Intervention Type DRUG

receiving the combination of pregabalin and duloxetine

Interventions

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esketamine group

In the esketamine group, in addition to receiving the combination of pregabalin and duloxetine, patients will also undergo a single intravenous infusion of esketamine.

Intervention Type DRUG

control group

receiving the combination of pregabalin and duloxetine

Intervention Type DRUG

Other Intervention Names

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pregabalin+duloxetine+esketamine pregabalin+duloxetine

Eligibility Criteria

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Inclusion Criteria

1. Ages more than 18 years;
2. Pain present for more than 3 months after healing of a herpes zoster skin rash;
3. Has an average pain score of at least 4 on a Numeric Rating Scale (NRS, 0= no pain, 10= worst possible pain)；
4. Failed to respond to or tolerate the effective dose of pregabalin monotherapy.

Exclusion Criteria

1. Obstructive sleep apnoea syndrome;
2. Those who receive interventional treatments;
3. A history of systemic immune diseases, organ transplantation, or cancers;
4. A history of severe cardiopulmonary, hepatic or renal dysfunction;
5. A history of schizophrenia, epilepsy, or myasthenia gravis, delirium;
6. Currently using monoamine oxidase inhibitors (MAOIs);
7. Having untreated angle-closure glaucoma;
8. Those suffering from increased intracranial pressure；
9. Comorbid hyperthyroidism or phaeochromocytoma;
10. Suspected or confirmed history of drug abuse;
11. Having contraindications to esketamine, pregabaline or duloxetine;
12. Communication difficulties;
13. Women who are preparing for pregnancy, in the pregnancy or lactation period.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No