Postherpetic; Neuralgia, Trigeminal (Etiology)
Conditions
Keywords
trigeminal postherpetic neuralgia, esketamine
Brief summary
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).
Detailed 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
Interventions
DRUGesketamine group
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.
DRUGcontrol group
In the control group, patients will receive PRF+pregabaline treatment. Pulsed radiofrequency (PRF) will be performed on GG by a designated physician in each participating center. PRF treatment (PMG-230, Baylis Medical Inc.) targeting to GG 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.
Sponsors
Beijing Xiaotangshan Hospital
The First Hospital of Fangshan District,Beijing
Beijing Ditan Hospital
Hengshui People's Hospital
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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） | 7-day period | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| averaged weekly analgesic consumption | up to 12 weeks | averaged weekly consumption per analgesic of each participant |
| the 12-item Short-Form Health Survey (SF-12) score | At the end of weeks 1, 2, 4, 8, and 12 after treatment | Quality of life (QoL) assessed by the SF-12 score(range 0-100, with higher scores indicating better health status) |
| the Pittsburgh Sleep Quality Index (PSQI) score | At the end of weeks 1, 2, 4, 8, and 12 after treatment | Sleep quality measured by PSQI score(range 0-21, with higher scores indicating poorer sleep quality) |
| average weekly NRS score | up to 12 weeks | average weekly NRS score of each participants for rescue analgesia.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 |
| the Hospital Anxiety and Depression Scale (HADS) | At the end of weeks 1, 2, 4, 8, and 12 after treatment | It 6.consists of two sub-scales. Each sub-scale consists of 7 items and each item scored from 0 to 3. A higher score indicates more severe anxiety or depression. A score of 11 or above can indicate clinically significant anxiety or depression. |
| Safety assessments | Conducted on Day 0, Day 1, Day 3, and at the end of weeks 1, 2, 4, 8, and 12 after treatment | intraoperative complications, PRF-related complications, Eskatamine-related complications, Pregabaline-related complications |
| the Patient Global Impression of Change scale (PGIC) | At the end of weeks 1, 2, 4, 8, and 12 after treatment | The Patient Global Impression of Change (PGIC) is usually a 7 - point scale. The scale title is Patient Global Impression of Change. The minimum value is 1 and the maximum value is 7.In summary, for the PGIC scale, lower scores (from 1 to 3) mean a better outcome, indicating improvement in the patient's condition, while higher scores (from 5 to 7) mean a worse outcome, suggesting a deterioration of the condition. Score 4 represents a neutral state of no change. |
Countries
China
Contacts
Primary ContactFang Luo, M.D.
Outcome results
None listed