Anesthetic Efficacy of PECS II Block and Parasternal Block

Anesthetic Efficacy of PECS II Block and Parasternal Block for Quadrantectomy With or Without Axillary Dissection

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

Study Overview

• Status: Completed
• Conditions: Anesthesia, Local
• Intervention / Treatment: Procedure: Pecs II block and parasternal block

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 Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • L'Aquila
    • Coppito, L'Aquila, Italy, 67100
      • San Salvatore Academic Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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

Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: San Salvatore Hospital of L'Aquila
• Investigators: Principal Investigator: Pierfrancesco Fusco, MDD, San Salvatore Academic Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2017
• Primary Completion (Actual): October 25, 2017
• Study Completion (Actual): November 29, 2018

Study Registration Dates

• First Submitted: January 6, 2017
• First Submitted That Met QC Criteria: January 6, 2017
• First Posted (Estimate): January 10, 2017

Study Record Updates

• Last Update Posted (Actual): January 23, 2019
• Last Update Submitted That Met QC Criteria: January 19, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: SanSalvatoreH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No