Efficacy of Paraspinous Anesthetic Block in Patients With Chronic Pelvic Pain Non-Responsive to Pharmacological Treatment
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change of pain from baseline
研究概览
简要总结
This study examines randomized triple-blind clinical trial and the efficacy of paraspinous anesthetic block on the treatment of chronic pelvic pain in patients non-responsive to pharmacological management. Sixty patients will be randomly divided and allocated into group intervention (paraspinous anesthetic block) and control (placebo procedure in subcutaneous tissue).
详细描述
Patients will be allocated into one of two groups (intervention or placebo), and will be submitted to the corresponding procedure (paraspinous anesthetic block or placebo puncture in subcutaneous tissue). In the first appointment, pain will be measured with the VAS (Visual Analogue Scale); quality of life and function basal level will be evaluated by scales SF-36 (Medical Outcome Short-Form (36)Health Survey)and FSFI (Female Sexual Function Index), in Portuguese validated versions. Procedure will be realized as planned for each group.
Second appointment will occur one week after the procedure, and VAS scale will be applied.
Third appointment will occur in one month. VAS scale will be applied again,and procedure will be repeated if patient does not have a reduction of at least 30% of pain.
Next consultations will occur at two months, three months, four months and five months, with application of VAS scale to keep monitoring evolution of pain.
At six months of study, VAS scale will be applied along with SF-36 and FSFI questionnaires, to evaluate improvement in pain and in quality of life and function level.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with benign pelvic pain non-responsive to pharmacological treatment, lasting at least 6 months, located in the anatomic pelvis, anterior abdominal wall, infra-umbilical region, lumbossacral region or buttocks. Pain must be hard enough to cause functional impairment or to motivate medical counseling. The absence of physical findings does not decreases the importance of pain, nether excludes the possibility of pelvic pathology.
排除标准
- •Patients who do not want to take part in the study
- •Age under 18 years old
- •Pelvic pain lasting less than 6 months
- •Relief or resolution of pain with pharmacological treatment
- •Pain of neoplastic origin
- •Known allergy or report of adverse reaction related to lidocaine
研究组 & 干预措施
control
Subcutaneous puncture with no anesthetic effect
干预措施: subcutaneous puncture with no anesthetic effect (Procedure)
paraspinous block
Paraspinous anesthetic block in the thoracolumbar region, in sensitized segments
干预措施: paraspinous anesthetic block (Procedure)
结局指标
主要结局
Change of pain from baseline
时间窗: Change of pain from baseline at one week, at one month, at two months, at three months, at four months, at five months and at six months
Primary outcome is the reduction of pain, measured with the Visual Analogue Scale (VAS).
次要结局
- Improvement of scores in the FSFI scale(At baseline and at six months)
- Improvement of scores in SF-36 scale(At baseline and at six months)