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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| paraspinous block | Experimental | Paraspinous anesthetic block in the thoracolumbar region, in sensitized segments |
|
| control | Sham Comparator | Subcutaneous puncture with no anesthetic effect |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| paraspinous anesthetic block | Procedure | Paraspinous anesthetic block with lidocaine 1% in sensitized segments of the thoracolumbar region |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen F Rosa, MD | Hospital de Clínicas de Porto Alegre | Principal Investigator |
| 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 | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Clínicas de Porto Alegre | Porto Alegre | Rio Grande do Sul | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25830642 | Derived | da Rosa KF, Amantea VA, dos Santos AC, Savaris RF. Efficacy of paraspinal anesthetic block in patients with chronic pelvic pain refractory to drug therapy: a randomized clinical trial. Rev Bras Ginecol Obstet. 2015 Mar;37(3):105-9. doi: 10.1590/SO100-720320150005201. |
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| subcutaneous puncture with no anesthetic effect | Procedure | Subcutaneous puncture with injection needle (no substance will be injected) |
|
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 |