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Paraspinous Anesthetic Block for Non-Responsive Pelvic Pain

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ClinicalTrials.gov Identifier: NCT01635205
Recruitment Status : Completed
First Posted : July 9, 2012
Last Update Posted : April 24, 2014
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

December 17, 2011
July 9, 2012
April 24, 2014
October 2011
May 2013   (Final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01635205 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
Same as current
Not Provided
Not Provided
 
Paraspinous Anesthetic Block for Non-Responsive Pelvic Pain
Efficacy of Paraspinous Anesthetic Block in Patients With Chronic Pelvic Pain Non-Responsive to Pharmacological Treatment
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).

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
  • Paraspinous Block
  • Pelvis Pain Chronic
  • 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)
  • Experimental: paraspinous block
    Paraspinous anesthetic block in the thoracolumbar region, in sensitized segments
    Intervention: Procedure: paraspinous anesthetic block
  • Sham Comparator: control
    Subcutaneous puncture with no anesthetic effect
    Intervention: Procedure: subcutaneous puncture with no anesthetic effect
da Rosa KF, Amantéa 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
Same as current
May 2013
May 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT01635205
GPPG 110082
Yes
Not Provided
Not Provided
Hospital de Clinicas de Porto Alegre
Hospital de Clinicas de Porto Alegre
Not Provided
Principal Investigator: Karen F Rosa, MD Hospital de Clínicas de Porto Alegre
Study Chair: Antonio C Santos, doctor Hospital de Clínicas de Porto Alegre
Study Chair: Ricardo F Savaris, doctor Hospital de Clínicas de Porto Alegre
Study Chair: Vinícius A Amantéa, MD Hospital de Clínicas de Porto Alegre
Hospital de Clinicas de Porto Alegre
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP