Paraspinous Anesthetic Block for Non-Responsive Pelvic Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT01635205
First received: December 17, 2011
Last updated: April 23, 2014
Last verified: April 2014
  Purpose

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).


Condition Intervention Phase
Paraspinous Block
Pelvis Pain Chronic
Procedure: paraspinous anesthetic block
Procedure: subcutaneous puncture with no anesthetic effect
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Paraspinous Anesthetic Block in Patients With Chronic Pelvic Pain Non-Responsive to Pharmacological Treatment

Resource links provided by NLM:


Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Primary outcome is the reduction of pain, measured with the Visual Analogue Scale (VAS).


Secondary Outcome Measures:
  • Improvement of scores in SF-36 scale [ Time Frame: At baseline and at six months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 60
Study Start Date: October 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: paraspinous block
Paraspinous anesthetic block in the thoracolumbar region, in sensitized segments
Procedure: paraspinous anesthetic block
Paraspinous anesthetic block with lidocaine 1% in sensitized segments of the thoracolumbar region
Sham Comparator: control
Subcutaneous puncture with no anesthetic effect
Procedure: subcutaneous puncture with no anesthetic effect
Subcutaneous puncture with injection needle (no substance will be injected)

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01635205

Locations
Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
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
  More Information

No publications provided

Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT01635205     History of Changes
Other Study ID Numbers: GPPG 110082
Study First Received: December 17, 2011
Last Updated: April 23, 2014
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Hospital de Clinicas de Porto Alegre:
Paraspinous block
Non-responsive chronic pelvic pain

Additional relevant MeSH terms:
Pelvic Pain
Pain
Signs and Symptoms
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014