Paraspinous BlockPhase 4NCT01635205

Paraspinous Anesthetic Block for Non-Responsive Pelvic Pain

A Phase 4 study testing paraspinous anesthetic block and subcutaneous puncture with no anesthetic effect in people with Paraspinous Block and Pelvis Pain Chronic, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Paraspinous Block, Pelvis Pain Chronic
What is being tested?: paraspinous anesthetic block and subcutaneous puncture with no anesthetic effect
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 1 siteBrazil
Study dates: Oct 2011to May 2013
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul

Other trials in Brazil

About this study

Official title: 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).

Read the 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.

Conditions: Paraspinous Block, Pelvis Pain Chronic
Being tested: paraspinous anesthetic block, subcutaneous puncture with no anesthetic effect
Keywords: Paraspinous block, Non-responsive chronic pelvic pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

paraspinous anesthetic blockProcedure or surgery
Paraspinous anesthetic block with lidocaine 1% in sensitized segments of the thoracolumbar region
subcutaneous puncture with no anesthetic effectProcedure or surgery
Subcutaneous puncture with injection needle (no substance will be injected)

Study groups in NCT01635205
Study group	Role	What they receive
paraspinous block	Experimental	Paraspinous anesthetic block in the thoracolumbar region, in sensitized segments Receives: Procedure: paraspinous anesthetic block
control	Sham comparator	Subcutaneous puncture with no anesthetic effect Receives: Procedure: subcutaneous puncture with no anesthetic effect

What is being measured

The primary outcome is the main question the study is designed to answer.

Change of pain from baseline
Primary outcome is the reduction of pain, measured with the Visual Analogue Scale (VAS).
Measured: 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
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.
Measured: 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.
Measured: At baseline and at six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2011May 2013

First posted9 Jul 2012 (estimated)
Study startOct 2011
Primary completionMay 2013
Study completionMay 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Paraspinous BlockStudies of the same condition, open and under way.
More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01635205
Sponsor's protocol ID: GPPG 110082
Status last verified: Apr 2014
First submitted: 17 Dec 2011
Last updated: 24 Apr 2014
Results posted: No
Data monitoring committee: Yes

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.
PubMed 25830642

Study at a glance

From the registry record, last updated by the sponsor on 24 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of Paraspinous Anesthetic Block in Patients With Chronic Pelvic Pain Non-Responsive to Pharmacological Treatment
ClinicalTrials.gov ID: NCT01635205
Acronym / sponsor ID: GPPG 110082
Conditions: Paraspinous Block, Pelvis Pain Chronic
Keywords: Paraspinous block, Non-responsive chronic pelvic pain
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (estimated)
Lead sponsor: Hospital de Clinicas de Porto AlegreUniversity, hospital or other
Study start: Oct 2011
Primary completion: May 2013 (actual)
Study completion: May 2013 (actual)
First posted: 9 Jul 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
paraspinous block	Experimental	Procedure: paraspinous anesthetic blockParaspinous anesthetic block in the thoracolumbar region, in sensitized segments
control	Sham comparator	Procedure: subcutaneous puncture with no anesthetic effectSubcutaneous puncture with no anesthetic effect

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
paraspinous anesthetic blockParaspinous anesthetic block with lidocaine 1% in sensitized segments of the thoracolumbar region	Procedure or surgery	paraspinous block
subcutaneous puncture with no anesthetic effectSubcutaneous puncture with injection needle (no substance will be injected)	Procedure or surgery	control

Primary outcome

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).

2 secondary outcomes

Improvement of scores in SF-36 scale
Time frame: At baseline and at six months
Improvement of scores in the FSFI scale
Time frame: At baseline and at six months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2014.
Derived from this study: PubMed 25830642da 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Karen F Rosa, MD principal investigator

Hospital de Clinicas de Porto Alegre

Antonio C Santos, doctor study chair

Hospital de Clinicas de Porto Alegre

Ricardo F Savaris, doctor study chair

Hospital de Clinicas de Porto Alegre

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01635205, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2014.