NCT01635205

Paraspinous Anesthetic Block for Non-Responsive Pelvic Pain

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Hospital de Clinicas de Porto Alegre · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Paraspinous Block
• Pelvis Pain Chronic

Interventions

Type	Name	Description
PROCEDURE	paraspinous anesthetic block	Paraspinous anesthetic block with lidocaine 1% in sensitized segments of the thoracolumbar region
PROCEDURE	subcutaneous puncture with no anesthetic effect	Subcutaneous puncture with injection needle (no substance will be injected)

Timeline

• Start date: 2011-10-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2012-07-09
• Last updated: 2014-04-24

Locations

1 site across 1 country: Brazil