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).

Study Overview

• Status: Completed
• Conditions: Pelvis Pain Chronic; Paraspinous Block
• Intervention / Treatment: Procedure: paraspinous anesthetic block; Procedure: subcutaneous puncture with no anesthetic effect

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil
      • Hospital De Clinicas De Porto Alegre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Investigators: Principal Investigator: Karen F Rosa, MD, Hospital De Clinicas De Porto Alegre; Study Chair: Antonio C Santos, doctor, Hospital De Clinicas De Porto Alegre; Study Chair: Ricardo F Savaris, doctor, Hospital De Clinicas De Porto Alegre; Study Chair: Vinícius A Amantéa, MD, Hospital De Clinicas De Porto Alegre

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: December 17, 2011
• First Submitted That Met QC Criteria: July 3, 2012
• First Posted (Estimate): July 9, 2012

Study Record Updates

• Last Update Posted (Estimate): April 24, 2014
• Last Update Submitted That Met QC Criteria: April 23, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Paraspinous block; Non-responsive chronic pelvic pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pelvic Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: GPPG 110082