Paraspinous Anesthetic Block for Non-Responsive Pelvic Pain

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Efficacy of Paraspinous Anesthetic Block in Patients With Chronic Pelvic Pain Non-Responsive to Pharmacological Treatment

Conditions
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Paraspinous Block, Pelvis Pain Chronic

Intervention / Treatment
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* Procedure: paraspinous anesthetic block
* Procedure: subcutaneous puncture with no anesthetic effect


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: paraspinous block<br>Paraspinous anesthetic block in the thoracolumbar region, in sensitized segments | Procedure: paraspinous anesthetic block<br>* Paraspinous anesthetic block with lidocaine 1% in sensitized segments of the thoracolumbar region<br>|
| Sham Comparator: control<br>Subcutaneous puncture with no anesthetic effect | Procedure: subcutaneous puncture with no anesthetic effect<br>* Subcutaneous puncture with injection needle (no substance will be injected)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of pain from baseline | Primary outcome is the reduction of pain, measured with the Visual Analogue Scale (VAS). | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of scores in SF-36 scale | Quality of life will be evaluated with SF-36 scale at baseline and at six months, and scores will be compared at the end of the study. | At baseline and at six months | 
| Improvement of scores in the FSFI scale | Sexual function as a measure of functionality will be evalueted with the FSFI scale at baseline and at six months, and scores will be compared at the end of the study. | At baseline and at six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Paraspinous block, Non-responsive chronic pelvic pain