Esketamine Combined Pregabalin and Duloxetine for Postherpetic Neuralgia

Beijing Tiantan Hospital150 enrolled

Overview

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).

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

150

Conditions

Postherpetic Neuralgia

Interventions

esketamine groupDRUG

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

control groupDRUG

receiving the combination of pregabalin and duloxetine

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

the mean of daily pain scores

the mean of daily pain scores collected during week 1 of treatment measured using the Numerical Pain Rating Scale (NRS,, 0 represents no pain, and 10 represents the most severe pain.A higher score indicates more severe pain).

Time frame: during 1 week

Secondary Outcomes

Averaged weekly NRS score

Averaged weekly NRS score of each participant.Generally, 0 represents no pain, and 10 represents the most severe pain.A higher score indicates more severe pain

Time frame: 1 week, 2 weeks, 3 weeks, and 1 month after treatment

percentages of patients having >50% reductions in 24-hour average pain severity during the first week

percentages of patients having \>50% reductions

Time frame: during the first week

the 12-item Short-Form Health Survey (SF-12) score

Quality of life (QoL) assessed by the SF-12 score (range 0-100, with higher scores indicating better health status).

Time frame: 1 day, 3 days, 7 days, 2 weeks, 3 weeks, and 1 month after treatment

the Pittsburgh Sleep Quality Index (PSQI) score

Sleep quality measured by PSQI score (range 0-21, with higher scores indicating poorer sleep quality).

Time frame: 1 day, 3 days, 7 days, 2 weeks, 3 weeks, and 1 month after treatment

the Patient Global Impression of Change scale (PGIC)

The proportion of patients with a response of "no change", "minimally improved", "much improved" or "very much improved" on PGIC.

Time frame: 1 day, 3 days, 7 days, 2 weeks, 3 weeks, and 1 month after treatment

Central Contacts

Fang Luo, M.D.

CONTACT

+86 13611326978 13611326978@163.com

Data from ClinicalTrials.gov

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