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Active Not Recruiting NCT07828574

Pudendal Nerve Block With Articaine and Triamcinolone for Pudendal Neuralgia

Conditions: Pudendal Neuralgia Pudendal Nerve Entrapment Chronic Pelvic Pain

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 120
Sponsor: Irkutsk State Medical University

Location: Kharlampiev Clinic Irkutsk Irkutsk Regio

Summary

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.

Eligibility Criteria

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 \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07828574). StuddyBuddy aggregates publicly available trial information.