Anesthetic Efficacy of PECS II Block and Parasternal Block

NCT ID: NCT03016117

Last Updated: 2019-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-15

Study Completion Date

2018-11-29

Brief Summary

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The study evaluate the anesthetic efficacy of Pecs II block II and parasternal block during quadrantectomy with or without axillary dissection, in breast cancer surgery

Detailed Description

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All patients receive Pecs II block and parasternal block, under ultrasound guidance. Pecs II block, performed at the 4th rib level, and parasternal block performed at the level of the 2nd and 4th intercostal space level. Data on the anesthesia, side effects and pain, will be recorded

Conditions

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Anesthesia, Local

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pecs II block and parasternal block

Pecs II block and parasternal block performed to provide anesthesia of breast, before of quadrantectomy with or without axillary dissection. Pecs II block performed at the 4th rib level and 20 ml of 0.5% Levobupivacaine injected, and parasternal block performed at the level of the 2nd and 4th intercostal space level, and 4 ml of 0.375% Levobupivacaine injected

Group Type EXPERIMENTAL

Pecs II block and parasternal block

Intervention Type PROCEDURE

The Pecs II block will be performed under ultrasound guidance, at fourth rib level, on the axillary line, into the fascial plane between pectoralis minor muscle and serratus muscle. The parasternal block will be performed under ultrasound guidance, at the second and fourth intercostal space, between the pectoralis major muscle and the intercostal muscles, near to the external intercostal membrane.

Interventions

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Pecs II block and parasternal block

The Pecs II block will be performed under ultrasound guidance, at fourth rib level, on the axillary line, into the fascial plane between pectoralis minor muscle and serratus muscle. The parasternal block will be performed under ultrasound guidance, at the second and fourth intercostal space, between the pectoralis major muscle and the intercostal muscles, near to the external intercostal membrane.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* patients who need of quadrantectomy with or without axillary dissection
* ASA I-III patients
* age between 18 and 75 years
* filled informed consent

Exclusion Criteria

* pregnant women
* obesity (BMI \> 39,99)
* radical mastectomy
* ASA IV patients
* chest wall abnormalities
* neurological disorders
* septic status
* chest skin infections
* coagulopathies
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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San Salvatore Hospital of L'Aquila

OTHER

Sponsor Role lead

Responsible Party

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Emiliano Petrucci

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pierfrancesco Fusco, MDD

Role: PRINCIPAL_INVESTIGATOR

San Salvatore Academic Hospital

Locations

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San Salvatore Academic Hospital

Coppito, L'Aquila, Italy

Site Status

Countries

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Italy

Other Identifiers

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SanSalvatoreH

Identifier Type: -

Identifier Source: org_study_id

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