Esketamine Combined With PRF of DRG for Acute/Subacute Zoster-associated Pain
NCT ID: NCT06914206
Last Updated: 2025-04-09
Study Results
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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NOT_YET_RECRUITING
NA
184 participants
INTERVENTIONAL
2025-04-01
2026-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Esketamine group
Esketamine+ PRF group
esketamine group
in addition to receiving the combination of PRF of DRG and standardized drug treatment, patients will also undergo a single intravenous infusion of esketamine.
control group
PRF group
PRF group
In the control group, patients will receive PRF+standardized drug treatment. Pulsed radiofrequency (PRF) will be performed on DRG by an designated physician in each participating center. They 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 are carefully inserted until the needle tip reaches the upper edge of the intervertebral foramen. The parameters of PRF treatment will be set at 42 ℃, 2 Hz with 20 milliseconds current. The standardized drug treatment will include antiviral therapy, anticonvulsant treatment, three-step analgesic therapy
Interventions
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esketamine group
in addition to receiving the combination of PRF of DRG and standardized drug treatment, patients will also undergo a single intravenous infusion of esketamine.
PRF group
In the control group, patients will receive PRF+standardized drug treatment. Pulsed radiofrequency (PRF) will be performed on DRG by an designated physician in each participating center. They 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 are carefully inserted until the needle tip reaches the upper edge of the intervertebral foramen. The parameters of PRF treatment will be set at 42 ℃, 2 Hz with 20 milliseconds current. The standardized drug treatment will include antiviral therapy, anticonvulsant treatment, three-step analgesic therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients with onset of herpes zoster (HZ) rash less than 90 days;
3. HZ affected the spinal nerves (cervical/thoracic/lumbar nerve);
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 dorsal root ganglion(DRG).
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Beijing Xiaotangshan Hospital
OTHER
The First Hospital of Fangshan District,Beijing
OTHER
Beijing Ditan Hospital
OTHER
Hengshui People's Hospital
OTHER
Beijing Tiantan Hospital
OTHER
Responsible Party
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Fang Luo
Director of Department of Day surgery and Pain Management
Locations
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Beijing Tiantan Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Other Identifiers
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KY-2024-332-02-04
Identifier Type: -
Identifier Source: org_study_id
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