Breast CancerNCT01818817
Ultrasound Paravertebral Block in Breast Surgery.
An observational study of Breast Cancer, run by Campus Bio-Medico University at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2011to Feb 2012
- Phase
- Observational
- 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 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patient candidate for minor breast surgery.
Who may be able to join
- American Society of Anesthesiologists classification I-III
- Written informed consent
- Age older than 18 years old
Who cannot join
- allergy to local anesthetics
- local sepsis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer
- Keywords
- Ultrasound-guided paravertebral block, regional anesthesia, breast surgery
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain
The anesthesist evaluated the post-operative pain at rest and in movement with the NRS at 3-6-12-24 hours.
Measured: Up to 24 hours
Secondary outcomes (2)
Consumption of analgesic drugs
We register the consumption of analgesic drugs in both groups in the post-operative period till 24 hours.
Measured: up to 24 hours
Efficacy of Paravertebral block
We evaluate efficacy and extension of the block with ice test and pin-prick test
Measured: pre-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2013 (estimated)
- Study startNov 2011
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Campus Bio-Medico University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Massimiliano Carassiti, Campus Bio-Medico University
- Investigators
- Massimiliano Carassiti, MD, Principal investigator, Campus Bio Medico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01818817
- Sponsor's protocol ID
- CarGal2
- Other IDs
- TPVB
- Status last verified
- Sep 2011
- First submitted
- 23 Mar 2013
- Last updated
- 27 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Injection, Ultrasound Guided Paravertebral Block for Anesthesia in Breast Surgery.
- ClinicalTrials.gov ID
- NCT01818817
- Acronym / sponsor ID
- CarGal2
- Conditions
- Breast Cancer
- Keywords
- Ultrasound-guided paravertebral block, regional anesthesia, breast surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Campus Bio-Medico UniversityUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 27 Mar 2013 (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.
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.
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 design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TPVB group | – | –In this group of patients thoracic paravertebral block is performed. |
| GA group | – | –In this group of patients general anesthesia is performed. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient candidate for minor breast surgery.
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists classification I-III
- Written informed consent
- Age older than 18 years old
Key exclusion criteria (2 listed)
- allergy to local anesthetics
- local sepsis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Consumption of analgesic drugs
Time frame: up to 24 hours
Efficacy of Paravertebral block
Time frame: pre-operative
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 27 Mar 2013.
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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.
Massimiliano Carassiti, MD principal investigator
Campus Bio Medico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Campus Bio-Medico University at 1 site in Italy.
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 3 inclusion and 2 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 27 Mar 2013. 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 Italy. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Post-operative pain (time frame: Up to 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2013; AzTrials last refreshed its copy on 6 Nov 2026.