跳至主要内容
临床试验/NCT06872437
NCT06872437招募中3 期

EFFICACY OF THE USUAL TREATMENT WITH INFILTRATION OF LOCAL ANAESTHETIC IN THE TREATMENT OF PUDENDAL NEURALGIA: A RANDOMISED TRIAL COMPARED WITH A PHYSIOLOGICAL SERUM

Groupe Hospitalier Diaconesses Croix Saint-Simon1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年12月8日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
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 vs.saline) of the rate of patients with a decrease of at least 3 points on a visual 3 points on a visual analogue pain scale (VAS) between inclusion and

研究概览

简要总结

Pudendal neuralgia (PN) is a chronic nerve compression syndrome causing neuropathic pain. Treatment includes medication, infiltration and decompressive surgery. Medicinal treatment involves the use of drugs that have proved effective in other areas, such as shingles or diabetes. There is no consensus on the molecules to be used for pudendal nerve infiltration (PNTI), and less than half of patients experience short-term relief. The only risk factor for failure is the duration of pain. Our study proposes to compare the usual treatment with a placebo, as no type of infiltration has been compared with a placebo.

详细描述

Like carpal tunnel syndrome, pudendal neuralgia (PN) is defined as a syndrome of chronic nerve compression (of the pudendal nerve) causing neuropathic pain.

Treatment of NP is based on 3 therapeutic strategies of increasing aggressiveness: drug treatment, infiltrations and decompressive surgery.

Drug treatment is based on the "empirical" use of drugs for neuropathic pain that have proved effective in other areas (shingles, diabetes, etc.). People with this disease are generally considered 'non-responders' to drug treatment after failure (decrease in VAS scale < 3) of at least one antidepressant and one antiepileptic drug, whose doses have been increased to the maximum possible level, or in whom a side effect has prevented the dose from being increased to the maximum authorised level.

For pudendal nerve infiltration (ITNP), there is no consensus or recommendation on which molecules to use. Most studies have used a combination of local anaesthetics and corticosteroids. However, a randomised controlled trial, researchers compare lidocaine infiltration with or without methylprednisolone. The results were not significantly different (14% vs 11%).

According to the data in the literature, less than half of patients (11% to 39%) are relieved in the short term, up to 3 months, and only about 10% (6.8% to 12.2%) are still relieved at 1 year. The only recognised risk factor for failure seems to be the duration of pain (more than 1 year). Other risk factors have been described in the literature, but only in one study and not in the others, such as gender (male or female), age (over or under 70), duration of pain (over or under 1 year), and whether the pain is bilateral or not.

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
Single (Participant)

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,
  • •Expressed consent to participate in the study
  • •Affiliated or beneficiary of a social security plan
  • •With pudendal neuralgia (Nantes criteria "modified" Nantes criteria).
  • •MRI normal or without pathology explaining the pain
  • •Drug treatment failure as defined in the LOS, i.e., failure (VAS decrease < 3) of at least one antiepileptic drug and an antidepressant whose dosages have been to the maximum possible dosage, or in whom a side effect for whom a side effect could not allow the dose to be increased to its to its maximum allowed dose.

排除标准

  • •Patient benefiting from a legal protection measure
  • •Pregnant or breastfeeding woman
  • •General and/or local infection (fistulous or cutaneous suppuration of the anal margin) in progress
  • •Known neurological pathology that may explain the pain
  • •Psychiatric pathology requiring a drug treatment treatment
  • •Anticoagulants or haemostasis disorders
  • •Hypersensitivity to lidocaine hydrochloride, to local anesthetics
  • •Recurrent porphyrias

研究组 & 干预措施

Lidocaine

Active Comparator

Infiltration by injections of 6mL of lidocaine (10 mg/mL) per injection site (left ischioanal fossa, right ischioanal fossa right ischioanal fossa, coccyx)

干预措施: Lidocaine Injectable Solution (Drug)

Saline solution

Placebo Comparator

Infiltration by injections of 6mL of saline solution per injection site (left ischio-anal fossa, right ischio-anal fossa right ischio-anal fossa, coccyx)

干预措施: Saline Solution for Block (Drug)

结局指标

主要结局

Comparison between the two treatment arms (lidocaine vs.saline) of the rate of patients with a decrease of at least 3 points on a visual 3 points on a visual analogue pain scale (VAS) between inclusion and

时间窗: between inclusion and 1 month after the first injection.

次要结局

未报告次要终点

研究者

发起方
Groupe Hospitalier Diaconesses Croix Saint-Simon
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验