Efficacy of Pudendal Nerve Block With Articaine and Triamcinolone in Patients With Pudendal Neuropathy: A Prospective Randomized Placebo-Controlled Trial With Blinded Outcome Assessment
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Proportion of Participants With ≥50% Reduction in Pain Intensity at 4 Weeks
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Active block
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.
干预措施: Articaine and triamcinolone (Drug)
Placebo block
Single ultrasound-guided transperineal injection of 10 mL of 0.9% saline, using the identical needle, approach, and injection technique as the active arm.
干预措施: Placebo (0.9% sodium chloride) (Drug)
结局指标
主要结局
Proportion of Participants With ≥50% Reduction in Pain Intensity at 4 Weeks
时间窗: 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.
次要结局
- Change in Pain Intensity (NRS) Over Time(Baseline, 1, 2, 4, 8, 12, and 24 weeks)
- Change in Quality of Life (EQ-5D-5L)(Baseline, 12 and 24 weeks)
- Change in Sleep Quality (PSQI)(Baseline and 12 weeks)
- Change in Pudendal Neuralgia-Specific Functional Status (PNEQ)(Baseline and 12 weeks)
- Rescue Analgesic Use(Every 4 weeks, up to 24 weeks)
- Incidence of Treatment-Related Adverse Events(24 weeks)
研究者
Ivan A. Stepanov
Neurosurgeon, Kharlampiev Clinic или Associate Professor, Department of General Surgery, Irkutsk State Medical University
Irkutsk State Medical University