Pudendal Nerve Block With Articaine and Triamcinolone for Pudendal Neuralgia
Active, not recruitingNot applicableNCT07828574
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
This study is testing whether an injection of local anesthetic (articaine) combined with a steroid (triamcinolone), placed near the pudendal nerve under ultrasound guidance, can reduce pain in people with pudendal neuralgia - a chronic pain condition affecting the perineal area - when other treatments (such as medications and physical therapy) have not worked well enough. Participants are randomly assigned to receive either the active injection (articaine and triamcinolone) or a placebo injection (saline solution), without knowing which one they receive. Neither the participant, the person performing the injection, nor the person assessing the results afterward knows which group the participant is in. The main question the study is trying to answer is whether more people report at least 50% less pain four weeks after the injection with the active treatment compared with placebo. The study also looks at quality of life, sleep, physical function, use of pain medication, and side effects over 24 weeks after the injection.
Study details
- Official title
- Efficacy of Pudendal Nerve Block With Articaine and Triamcinolone in Patients With Pudendal Neuropathy: A Prospective Randomized Placebo-Controlled Trial With Blinded Outcome Assessment
- Conditions
- Pudendal Neuralgia Pudendal Nerve Entrapment Chronic Pelvic Pain
- Interventions
- Drug: Articaine and triamcinolone
- Drug: Placebo (0.9% sodium chloride)
- Sponsor
- Irkutsk State Medical University
- Start date
- 2025-01-15
- Primary completion
- 2026-06-18
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Russia
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Clinical Nantes criteria for pudendal neuralgia (all 4 mandatory criteria) * Pain intensity on the Numeric Rating Scale (NRS) greater than 4 out of 10 during the previous 7 days * Pain duration exceeding 3 months * Failure of prior conservative therapy (pregabalin ≥150 mg/day, or gabapentin ≥900 mg/day, or physical therapy) for more than 8 weeks * Age 18 years or older Exclusion Criteria: * Pudendal nerve compression by a space-occupying lesion (tumor, cyst, endometriosis) on pelvic MRI * Coagulopathy (INR \>1.4, platelets \<50×10\^9/L) * Use of anticoagulants or antiplatelet agents that cannot be discontinued 5-7 days before the block (per cardiology consultation) * Active infection at the intended injection site, or systemic infection/sepsis * Allergy to amide-type local anesthetics or corticosteroids * Pregnancy or lactation * Psychiatric conditions precluding understanding of the procedure or completion of questionnaires
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07828574