Paraspinous Anesthetic Block for Non-Responsive Pelvic Pain

NCT01635205 | Completed Phase 4 DMC

• 1 other identifier: GPPG 110082
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Paraspinous Block; Pelvis Pain Chronic

Keywords

Paraspinous block; Non-responsive chronic pelvic pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Improvement of scores in SF-36 scale

  At baseline and at six months

• Improvement of scores in the FSFI scale

  At baseline and at six months

Study Arms (2)

paraspinous block

EXPERIMENTAL

Paraspinous anesthetic block in the thoracolumbar region, in sensitized segments

Procedure: paraspinous anesthetic block

control

SHAM COMPARATOR

Subcutaneous puncture with no anesthetic effect

Procedure: subcutaneous puncture with no anesthetic effect

Interventions

paraspinous anesthetic block PROCEDURE

Paraspinous anesthetic block with lidocaine 1% in sensitized segments of the thoracolumbar region

paraspinous block

subcutaneous puncture with no anesthetic effect PROCEDURE

Subcutaneous puncture with injection needle (no substance will be injected)

control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Location

Related Publications (1)

• 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.

  PMID: 25830642 DERIVED

Study Officials

• Karen F Rosa, MD

  Hospital de Clínicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2011
• First Posted: July 9, 2012
• Study Start: October 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: April 24, 2014

Record last verified: 2014-04

Locations

BR (1)