Paraspinous Anesthetic Block for Non-Responsive Pelvic Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2013-05-31

Brief Summary

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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).

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Detailed Description

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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

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Paraspinous Block Pelvis Pain Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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paraspinous block

Paraspinous anesthetic block in the thoracolumbar region, in sensitized segments

Group Type EXPERIMENTAL

paraspinous anesthetic block

Intervention Type PROCEDURE

Paraspinous anesthetic block with lidocaine 1% in sensitized segments of the thoracolumbar region

control

Subcutaneous puncture with no anesthetic effect

Group Type SHAM_COMPARATOR

subcutaneous puncture with no anesthetic effect

Intervention Type PROCEDURE

Subcutaneous puncture with injection needle (no substance will be injected)

Interventions

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paraspinous anesthetic block

Paraspinous anesthetic block with lidocaine 1% in sensitized segments of the thoracolumbar region

Intervention Type PROCEDURE

subcutaneous puncture with no anesthetic effect

Subcutaneous puncture with injection needle (no substance will be injected)

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No