Pelvis Pain Chronic Clinical Trial
Official title:
Efficacy of Paraspinous Anesthetic Block in Patients With Chronic Pelvic Pain Non-Responsive to Pharmacological Treatment
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).
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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