Ultrasound Paravertebral Block in Breast Surgery.

March 23, 2013 updated by: Massimiliano Carassiti, Campus Bio-Medico University

Single Injection, Ultrasound Guided Paravertebral Block for Anesthesia in Breast Surgery.

The purpouse of the study is to determine wether Ultrasound Guided,Ens-assisted paravertebral block with single shot is a safe and reliable anesthetic technique in breast surgery.

Study Overview

Status

Completed

Conditions

Detailed Description

General anaesthesia is currently the conventional technique used for breast surgery. Thoracic Paravertebral block (PVB) has been used with multiple injection.

We compared a single injection thoracic PVB with general anaesthesia (GA) in 20 consenting patients, scheduled for unilateral breast surgery.

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • RM
      • Rome, RM, Italy, 00128
        • Campus Bio Medico

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patient candidate for minor breast surgery.

Description

Inclusion Criteria:

  • American Society of Anesthesiologists classification I-III
  • Written informed consent
  • Age older than 18 years old

Exclusion Criteria:

  • allergy to local anesthetics
  • local sepsis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
TPVB group
In this group of patients thoracic paravertebral block is performed.
GA group
In this group of patients general anesthesia is performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative pain
Time Frame: Up to 24 hours
The anesthesist evaluated the post-operative pain at rest and in movement with the NRS at 3-6-12-24 hours.
Up to 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Consumption of analgesic drugs
Time Frame: up to 24 hours
We register the consumption of analgesic drugs in both groups in the post-operative period till 24 hours.
up to 24 hours
Efficacy of Paravertebral block
Time Frame: pre-operative
We evaluate efficacy and extension of the block with ice test and pin-prick test
pre-operative

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative nausea and vomit
Time Frame: up to 24 hours
We register the incidence of nausea and vomit in the post-perative time.
up to 24 hours
Appreciation of patients
Time Frame: At 24 hours
We administer an assessment questionnaire to patients to evaluate the appreciation of the anesthesiologic technique
At 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Campus Bio-Medico University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

March 23, 2013

First Submitted That Met QC Criteria

March 23, 2013

First Posted (Estimate)

March 27, 2013

Study Record Updates

Last Update Posted (Estimate)

March 27, 2013

Last Update Submitted That Met QC Criteria

March 23, 2013

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CarGal2
  • TPVB (Other Identifier: CampusBioMedico)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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