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Completed

NCT Number: NCT01635205

Paraspinous Anesthetic Block for Non-Responsive Pelvic Pain

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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Key information

Conditions

Paraspinous Block Pelvis Pain Chronic

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

paraspinous anesthetic block

Procedure

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

subcutaneous puncture with no anesthetic effect

Procedure

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jul 9, 2012
Registry last updated
Apr 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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