EFFICACY of USUAL MANAGEMENT by LOCAL ANESTHETIC INFILTRATION in the TREATMENT of CHRONIC IDIOPATHIC ANO-PERINEAL PAIN: a RANDOMIZED DOUBLE-BLIND SALINE-CONTROLLED TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Comparison between the two treatment arms (lidocaine versus saline) of the rate of patients with a reduction of at least 3 points on a visual analog pain scale (VAS) between inclusion and 1 month after the first injection.
研究概览
简要总结
The goal of this clinical trial is to evaluate the efficacy of a posterior perineal block performed under neurostimulation at 1 month after local anesthetic infiltration in the treatment of chronic idiopathic ano-perineal pain.
The main questions aims to answer are :
- The efficacy of a posterior perineal block performed under neurostimulation on pain 1 month after local anesthetic infiltration in the treatment of chronic idiopathic ano-perineal pain.
- The rate of maintenance at 3 months of a positive response to the first infiltration.
- The pain-free rate at 1 month after the first infiltration.
- Evolution of quality of life and pain impact between inclusion and one month after the first infiltration.
- Changes in anxiety and depressive disorders associated with pain between inclusion and one month after the first infiltration.
- The evolution of symptoms related to central sensitization (both somatic and emotional) between inclusion and one month after the first infiltration.
Participants will :
- be managed with a posterior perineal block of lidocaine or saline solution under neurostimulation.
- complete a questionnaire on pain, anxiety and depression at inclusion and one month after injection of the research product (lidocaine or saline solution).
Researchers will compare between the two treatment arms (lidocaine versus saline solution) to see the rate of patients with a reduction of at least 3 points on a visual analog pain scale between inclusion and 1 month after the first injection.
详细描述
Chronic idiopathic ano-perineal pain (CICA) is defined as anoperineal pain involving the anal region that has been present for more than 3 months, and for which no cause has been identified on clinical examination or further investigations (MRI). The mechanisms underlying this pain are multiple, but involve the pudendal nerve in the majority of cases.
Therapeutic management of CDAD is based on 3 treatment strategies of progressively increasing aggressiveness: drug treatment, infiltrations and decompressive surgery.
Drug treatment is based on the "empirical" use of neuropathic pain medications with proven efficacy in other areas (shingles, diabetes, etc.). Patients are generally considered to be "non-responders" to drug treatment after failure (decrease in VAS scale < 3) of at least one antidepressant and one antiepileptic, whose dosages have been brought up to the maximum possible, or in whom a side effect has prevented the dose from being increased to its authorized maximum.
Therapeutic infiltrations most often involve the pudendal nerve (ITNP). Infiltration of the posterior branches of the sacrococcygeal roots is sometimes associated, to create a posterior perineal block (PPB). There is no consensus or recommendation on which molecules to use.
In most studies, a combination of local anesthetics and corticosteroids was used. However, Labat et al published the only randomized controlled trial comparing lidocaine infiltration of the pudendal nerve with or without methylprednisolone. Results were not significantly different (14% vs. 11%).
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Patient 18 years of age or older,
- •Express consent to participate in the study
- •Affiliated or beneficiary of a social security plan
- •Presenting chronic idiopathic ano-perineal pain
- •MRI normal or without pathology explaining pain (Multidisciplinary consultation meeting reread if in doubt)
- •Resistance to "standard" 1st-line medical treatment (level 1 or 2 analgesics and/or non-steroidal anti-inflammatory and/or local topicals)
排除标准
- •Patient benefiting from a legal protection measure
- •Pregnant or breast-feeding woman
- •General and/or local infection (fistulous or cutaneous suppuration of anal margin) in progress
- •Known neurological pathology that may explain pain
- •Psychiatric pathology requiring medication
- •Anticoagulants or haemostasis disorders
- •Hypersensitivity to lidocaine hydrochloride or local anesthetics
- •Recurrent porphyrias
研究组 & 干预措施
experimental ARMS
treated with lidocaine 10 mg/ml
干预措施: Lidocaine 10 MG/ML (Drug)
placebo arm
treated with placebo;salin solution
干预措施: Saline (Drug)
结局指标
主要结局
Comparison between the two treatment arms (lidocaine versus saline) of the rate of patients with a reduction of at least 3 points on a visual analog pain scale (VAS) between inclusion and 1 month after the first injection.
时间窗: 3 month
Comparison between the two treatment arms (lidocaine versus saline) of the rate of patients with a reduction of at least 3 points on a visual analog pain scale (VAS)(lower value is 0 and means no pain, higher is 10 means the maximum of pain) between inclusion and 1 month after the first injection. The rate of successful patients at M1 between the two randomization arms will be analyzed using logistic regression, with treatment success or failure as the explanatory variable and randomization arm and duration of pain (stratification factor) as the explanatory variables.
次要结局
未报告次要终点