Trials Sponsors Conditions Drugs Pricing

Conditions

Postherpetic; Neuralgia, Trigeminal (Etiology)

Keywords

trigeminal postherpetic neuralgiaesketamine

Outcome Measures

Primary Outcomes (1)

1.the difference between the means of the daily mean pain scores over the first 7 days, measured on an 11-point Numeric Rating Scale（NRS）
NRS score is a way to quantify the degree of subjective feelings such as pain using numbers. Generally, 0 represents no pain, and 10 represents the most severe pain.A higher score indicates more severe pain
7-day period

Secondary Outcomes (7)

average weekly NRS score
up to 12 weeks
averaged weekly analgesic consumption
up to 12 weeks
the 12-item Short-Form Health Survey (SF-12) score
At the end of weeks 1, 2, 4, 8, and 12 after treatment
the Pittsburgh Sleep Quality Index (PSQI) score
At the end of weeks 1, 2, 4, 8, and 12 after treatment
the Patient Global Impression of Change scale (PGIC)
At the end of weeks 1, 2, 4, 8, and 12 after treatment
+2 more secondary outcomes

Study Arms (2)

esketamine group

EXPERIMENTAL

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

Drug: esketamine group

control group

PLACEBO COMPARATOR

patients will receive PRF treatment+pregabalin

Drug: control group

Interventions

esketamine groupDrug

In the esketamine group, in addition to receiving PRF treatment+pregabalin for rescue analgesia, 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.

Also known as: esketamine+PRF

esketamine group

control groupDrug

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Ages more than 18 years;
Pain persisting for over three months following the onset of the herpes zoster skin rash;

Sponsors & Collaborators

Hengshui People's Hospital
Othercollaborator
Beijing Xiaotangshan Hospital
Othercollaborator
The First Hospital of Fangshan District,Beijing

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

MeSH Terms

Conditions

Neuralgia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative Techniques

Central Study Contacts

Fang Luo, M.D.

CONTACT

+86 13611326978 13611326978@163.com

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Director of Department of Day surgery and Pain Management

Study Record Dates

First Submitted

March 25, 2025

First Posted

April 6, 2025

Study Start

April 1, 2025

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

Esketamine Combined With PRF for Trigeminal Postherpetic Neuralgia

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (2)

esketamine group

control group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (2)

esketamine group

control group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations