Ultrasound Paravertebral Block in Breast Surgery.

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01818817
• Other study ID #: CarGal2
• Secondary ID: TPVB
• Status: Completed
• Phase: N/A
• First received: March 23, 2013
• Last updated: March 23, 2013
• Start date: November 2011
• Est. completion date: February 2012

Study information

• Verified date: September 2011
• Source: Campus Bio-Medico University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer

Locations

Country	Name	City	State
Italy	Campus Bio Medico	Rome	RM

Sponsors (1)

Lead Sponsor	Collaborator
Campus Bio-Medico University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Post-operative nausea and vomit	We register the incidence of nausea and vomit in the post-perative time.	up to 24 hours	Yes
Other	Appreciation of patients	We administer an assessment questionnaire to patients to evaluate the appreciation of the anesthesiologic technique	At 24 hours	Yes
Primary	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	Yes
Secondary	Consumption of analgesic drugs	We register the consumption of analgesic drugs in both groups in the post-operative period till 24 hours.	up to 24 hours	Yes
Secondary	Efficacy of Paravertebral block	We evaluate efficacy and extension of the block with ice test and pin-prick test	pre-operative	Yes