Paraspinous Anesthetic Block for Non-Responsive Pelvic Pain
|Paraspinous Block Pelvis Pain Chronic||Procedure: paraspinous anesthetic block Procedure: subcutaneous puncture with no anesthetic effect||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
|Official Title:||Efficacy of Paraspinous Anesthetic Block in Patients With Chronic Pelvic Pain Non-Responsive to Pharmacological Treatment|
- Change of pain from baseline [ Time Frame: 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).
- Improvement of scores in SF-36 scale [ Time Frame: At baseline and at six months ]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.
- Improvement of scores in the FSFI scale [ Time Frame: At baseline and at six months ]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.
|Study Start Date:||October 2011|
|Study Completion Date:||May 2013|
|Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
Experimental: paraspinous block
Paraspinous anesthetic block in the thoracolumbar region, in sensitized segments
Procedure: paraspinous anesthetic block
Paraspinous anesthetic block with lidocaine 1% in sensitized segments of the thoracolumbar region
Sham Comparator: control
Subcutaneous puncture with no anesthetic effect
Procedure: subcutaneous puncture with no anesthetic effect
Subcutaneous puncture with injection needle (no substance will be injected)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01635205
|Hospital de Clínicas de Porto Alegre|
|Porto Alegre, Rio Grande do Sul, Brazil|
|Principal Investigator:||Karen F Rosa, MD||Hospital de Clínicas de Porto Alegre|
|Study Chair:||Antonio C Santos, doctor||Hospital de Clínicas de Porto Alegre|
|Study Chair:||Ricardo F Savaris, doctor||Hospital de Clínicas de Porto Alegre|
|Study Chair:||Vinícius A Amantéa, MD||Hospital de Clínicas de Porto Alegre|