Anesthetic Efficacy of PECS II Block and Parasternal Block

NCT03016117 | Completed DMC

• 1 other identifier: SanSalvatoreH
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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

Conditions

Anesthesia, Local

Outcome Measures

Primary Outcomes (1)

• Anesthetic efficacy

  The anesthetic efficacy is tested by cold and touch test

  The anesthetic efficacy was assessed in the first 72 hours, after block

Secondary Outcomes (2)

• Painkillers request

  The painkillers request was assessed in the first 72 hours, after surgery

• Side effects

  The side effects recorded in the first 72 hours, after surgery

Study Arms (1)

Pecs II block and parasternal block

EXPERIMENTAL

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

Procedure: Pecs II block and parasternal block

Interventions

Pecs II block and parasternal block 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.

Pecs II block and parasternal block

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• San Salvatore Hospital of L'Aquila: lead

Study Sites (1)

San Salvatore Academic Hospital

Coppito, L'Aquila, 67100, Italy

Location

Study Officials

• Pierfrancesco Fusco, MDD

  San Salvatore Academic Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 6, 2017
• First Posted: January 10, 2017
• Study Start: March 15, 2017
• Primary Completion: October 25, 2017
• Study Completion: November 29, 2018
• Last Updated: January 23, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)