Paraspinous Anesthetic Block for Non-Responsive Pelvic Pain

Hospital de Clinicas de Porto Alegre

Status and phase: Completed; Phase 4

Conditions: Paraspinous Block; Pelvis Pain Chronic

Treatments: Procedure: paraspinous anesthetic block; Procedure: subcutaneous puncture with no anesthetic effect

Study type: Interventional

Funder types: Other

Identifiers

NCT01635205

GPPG 110082

Details and patient eligibility

About

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).

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

paraspinous block

Experimental group

Description:

Paraspinous anesthetic block in the thoracolumbar region, in sensitized segments

Treatment:

Procedure: paraspinous anesthetic block

control

Sham Comparator group

Description:

Subcutaneous puncture with no anesthetic effect

Treatment:

Procedure: subcutaneous puncture with no anesthetic effect