Anesthetic Efficacy of PECS II Block and Parasternal Block

Not Applicable

Completed

• Conditions: Anesthesia, Local
• Interventions: Procedure: Pecs II block and parasternal block

• Registration Number: NCT03016117
• Lead Sponsor: San Salvatore Hospital of L'Aquila

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2017-01-06
• Study First Submitted QC: 2017-01-06
• Study First Posted: 2017-01-10
• Study Start: 2017-03-15
• Primary Completion: 2017-10-25
• Study Completion: 2018-11-29
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-19
• Last Update Posted: 2019-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 65

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pecs II block and parasternal block	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

Primary Outcome Measures

Name	Time	Method
Anesthetic efficacy	The anesthetic efficacy was assessed in the first 72 hours, after block	The anesthetic efficacy is tested by cold and touch test

Secondary Outcome Measures

Name	Time	Method
Side effects	The side effects recorded in the first 72 hours, after surgery	Nausea, vomiting, local anesthetic systemic toxicity
Painkillers request	The painkillers request was assessed in the first 72 hours, after surgery	mg of morphine

Trial Locations

Locations (1)

San Salvatore Academic Hospital; 🇮🇹 Coppito, L'Aquila, Italy