Paraspinous Anesthetic Block for Non-Responsive Pelvic Pain

Pelvis Pain Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01635205
• Other study ID #: GPPG 110082
• Status: Completed
• Phase: Phase 4
• First received: December 17, 2011
• Last updated: April 23, 2014
• Start date: October 2011
• Est. completion date: May 2013

Study information

• Verified date: April 2014
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Paraspinous Block
• Pelvic Pain
• Pelvis Pain Chronic

Intervention

Procedure:
• paraspinous anesthetic block
Paraspinous anesthetic block with lidocaine 1% in sensitized segments of the thoracolumbar region
• subcutaneous puncture with no anesthetic effect
Subcutaneous puncture with injection needle (no substance will be injected)

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of pain from baseline	Primary outcome is the reduction of pain, measured with the Visual Analogue Scale (VAS).	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	No
Secondary	Improvement of scores in SF-36 scale	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.	At baseline and at six months	No
Secondary	Improvement of scores in the FSFI scale	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.	At baseline and at six months	No