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Pudendal Nerve Block With Articaine and Triamcinolone for Pudendal Neuralgia
Sponsor: Irkutsk State Medical University
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2025-01-15
Completion Date
2026-11-10
Last Updated
2026-09-18
Healthy Volunteers
No
Interventions
Articaine and triamcinolone
Perineural injection of articaine hydrochloride with epinephrine (20 mg/mL + 0.005 mg/mL, 5 mL) combined with triamcinolone acetonide (40 mg in 1 mL), diluted with 0.9% saline to a total volume of 10 mL, administered as a single ultrasound-guided transperineal pudendal nerve block.
Placebo (0.9% sodium chloride)
Single ultrasound-guided transperineal injection of 10 mL of 0.9% sodium chloride solution (saline), using the same needle, approach, and injection technique as the active intervention, without active pharmacological agent.
Locations (1)
Kharlampiev Clinic
Irkutsk, Irkutsk Regio, Russia