An interventional study of Articaine and triamcinolone and Placebo (0.9% sodium chloride) in Pudendal Neuralgia Pudendal Nerve Entrapment Chronic Pelvic Pain, sponsored by Irkutsk State Medical University. Active, not recruiting at 1 site in Russia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Irkutsk State Medical University · Not applicable, Interventional, and Treatment
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.
This is a single-center, prospective, randomized, placebo-controlled, parallel-group trial conducted at Kharlampiev Clinic (Irkutsk, Russia), a clinical base of Irkutsk State Medical University. Patients meeting the clinical Nantes criteria for pudendal neuralgia, with pain refractory to conservative therapy, are randomized 1:1 to receive a single ultrasound-guided transperineal pudendal nerve block with either articaine 5 mL (20 mg/mL with epinephrine 1:200,000) plus triamcinolone acetonide 40 mg, or an equal volume of 0.9% saline (placebo), both brought to a total volume of 10 mL with saline.
Randomization is performed using a computer-generated sequence with a fixed block size, by an independent staff member not involved in patient care or outcome assessment. Study medication is prepared by a designated unblinded staff member; the treating physician, outcome assessor, and participant remain blinded to group assignment throughout the study.
The primary outcome is the proportion of participants achieving a reduction of more than 50% in pain intensity on a 0-10 Numeric Rating Scale (NRS) at 4 weeks after the injection. Secondary outcomes include NRS pain scores at 1, 2, 8, 12, and 24 weeks; quality of life (EQ-5D-5L); sleep quality (Pittsburgh Sleep Quality Index, PSQI); pudendal neuralgia-specific functional status (PNEQ); rescue analgesic use; and treatment-related adverse events over 24 weeks of follow-up.
375 studies on the registry are indexed under Pelvic Pain; 89 are open to participants now.
This study's enrollment of 120 is above the median of 60 across 277 interventional studies indexed under Pelvic Pain.
Browse Pelvic Pain studies →This is the only study on the registry with Irkutsk State Medical University as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single ultrasound-guided transperineal pudendal nerve block with articaine (5 mL, 20 mg/mL with epinephrine 1:200,000) and triamcinolone acetonide (40 mg/1 mL), diluted with 0.9% saline to a total volume of 10 mL.
Drug: Articaine and triamcinolone
Single ultrasound-guided transperineal injection of 10 mL of 0.9% saline, using the identical needle, approach, and injection technique as the active arm.
Drug: Placebo (0.9% sodium chloride)
Drug pages: Carticaine · 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.
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.
Proportion of Participants With ≥50% Reduction in Pain Intensity at 4 Weeks
Proportion of participants achieving more than 50% reduction in pain intensity on the 0-10 Numeric Rating Scale (NRS) compared with baseline, assessed 4 weeks after the pudendal nerve block.
Time frame: 4 weeks
Change in Pain Intensity (NRS) Over Time
Absolute change in pain intensity from baseline on the 0-10 Numeric Rating Scale.
Time frame: Baseline, 1, 2, 4, 8, 12, and 24 weeks
Change in Quality of Life (EQ-5D-5L)
Change from baseline in health-related quality of life, measured by the EQ-5D-5L index score.
Time frame: Baseline, 12 and 24 weeks
Change in Sleep Quality (PSQI)
Change from baseline in sleep quality, measured by the Pittsburgh Sleep Quality Index (PSQI) total score.
Time frame: Baseline and 12 weeks
Change in Pudendal Neuralgia-Specific Functional Status (PNEQ)
Change from baseline in pudendal-neuralgia-specific functional status, measured by the Pudendal Neuralgia Functional Questionnaire (PNEQ) total score. Time Frame: Baseline and 12 weeks
Time frame: Baseline and 12 weeks
Rescue Analgesic Use
Number of days per 4-week interval on which participants used rescue analgesics (nimesulide or ibuprofen), recorded in a patient diary.
Time frame: Every 4 weeks, up to 24 weeks
Incidence of Treatment-Related Adverse Events
Proportion of participants with procedure- or treatment-related adverse events, including injection-site hematoma, infection, transient pain exacerbation, and systemic anesthetic effects.
Time frame: 24 weeks
Plan to share: No
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This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Carticaine · Triamcinolone