NCT01818817

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 23, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 27, 2013

Completed
Last Updated

March 27, 2013

Status Verified

September 1, 2011

Enrollment Period

3 months

First QC Date

March 23, 2013

Last Update Submit

March 23, 2013

Conditions

Breast Cancer

Keywords

Ultrasound-guided paravertebral blockregional anesthesiabreast surgery

Outcome Measures

Primary Outcomes (1)

  • Post-operative pain

    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 Outcomes (2)

  • Consumption of analgesic drugs

    up to 24 hours

  • Efficacy of Paravertebral block

    pre-operative

Other Outcomes (2)

  • Post-operative nausea and vomit

    up to 24 hours

  • Appreciation of patients

    At 24 hours

Study Arms (2)

TPVB group

In this group of patients thoracic paravertebral block is performed.

GA group

In this group of patients general anesthesia is performed.

Eligibility Criteria

Age18 Years - 90 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient candidate for minor breast surgery.

You may qualify if:

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

You may not qualify if:

  • allergy to local anesthetics
  • local sepsis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Campus Bio Medico

Rome, RM, 00128, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Massimiliano Carassiti, MD

    Campus Bio Medico

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 23, 2013

First Posted

March 27, 2013

Study Start

November 1, 2011

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

March 27, 2013

Record last verified: 2011-09

Locations

IT(1)