Pudendal Neuralgia Pudendal Nerve Entrapment Chronic Pelvic Pain
Conditions
Keywords
pudendal nerve block articaine triamcinolone ultrasound-guided nerve block randomized controlled trial placebo-controlled chronic perineal pain
Brief 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.
Detailed description
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.
Interventions
DRUGArticaine 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.
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.
Sponsors
Irkutsk State Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants With ≥50% Reduction in Pain Intensity at 4 Weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Intensity (NRS) Over Time | Baseline, 1, 2, 4, 8, 12, and 24 weeks | Absolute change in pain intensity from baseline on the 0-10 Numeric Rating Scale. |
| Change in Quality of Life (EQ-5D-5L) | Baseline, 12 and 24 weeks | Change from baseline in health-related quality of life, measured by the EQ-5D-5L index score. |
| Change in Sleep Quality (PSQI) | Baseline and 12 weeks | Change from baseline in sleep quality, measured by the Pittsburgh Sleep Quality Index (PSQI) total score. |
| Change in Pudendal Neuralgia-Specific Functional Status (PNEQ) | Baseline and 12 weeks | 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 |
| Rescue Analgesic Use | Every 4 weeks, up to 24 weeks | Number of days per 4-week interval on which participants used rescue analgesics (nimesulide or ibuprofen), recorded in a patient diary. |
| Incidence of Treatment-Related Adverse Events | 24 weeks | Proportion of participants with procedure- or treatment-related adverse events, including injection-site hematoma, infection, transient pain exacerbation, and systemic anesthetic effects. |
Countries
Russia
Outcome results
None listed