Clinical trial NCT01635205: Paraspinous Anesthetic Block for Non-Responsive Pelvic Pain
Official title: Efficacy of Paraspinous Anesthetic Block in Patients With Chronic Pelvic Pain Non-Responsive to Pharmacological Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Paraspinous Block
Pelvis Pain Chronic
Keywords: Paraspinous block
Non-responsive chronic pelvic pain
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2012-07-09
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of pain from baseline
timeFrame: 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
Secondary outcomes:
measure: Improvement of scores in SF-36 scale
timeFrame: At baseline and at six months
measure: Improvement of scores in the FSFI scale
timeFrame: At baseline and at six months
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande do Sul
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Karen F Rosa, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Clínicas de Porto Alegre
name: Antonio C Santos, doctor
role: STUDY_CHAIR
affiliation: Hospital de Clínicas de Porto Alegre
name: Ricardo F Savaris, doctor
role: STUDY_CHAIR
affiliation: Hospital de Clínicas de Porto Alegre
name: Vinícius A Amantéa, MD
role: STUDY_CHAIR
References:
citation: 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.