drugset / Trial / NCT07828574

Pudendal Nerve Block With Articaine and Triamcinolone for Pudendal Neuralgia

NCT07828574 ↗

Active not recruiting 120 enrolled Irkutsk State Medical University
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2025-01-15
Primary completion
2026-06-18
Completion
2026-11-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Articaine Other / unclassified 100 mg Other
Subject Epinephrine Other / unclassified 0.025 mg Other
Subject Triamcinolone Other / unclassified 40 mg Other

Indications