Pecs II Block and PaB Could be an Alternative in Breast Surgery

Completed

• Conditions: Breast Cancer
• Interventions: Procedure: Pecs II and parasternal blocks

• Registration Number: NCT02865265
• Lead Sponsor: Emiliano Petrucci

Brief Summary

The association between ultrasound-guided Pecs II block and parasternal block can represent a valid alternative in the management of acute and postoperative pain syndrome after quadrantectomy with or without axillary dissection.

Detailed Description

The combination of Pecs II block and PaB provides good management of postoperative pain and can be considered a viable alternative to common anesthetic procedures performed for breast cancer surgery.

Study Timeline

• Study Start: 2013-03
• Primary Completion: 2013-03
• Study Completion: 2015-12
• Status Verified: 2016-08
• Study First Submitted: 2016-08-04
• Study First Submitted QC: 2016-08-09
• Last Update Submitted: 2016-08-09
• Study First Posted: 2016-08-12
• Last Update Posted: 2016-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 180

Inclusion Criteria

• 18-75 years of age;
• American Society of Anesthesiologists (ASA) physical status I-III,
• patients scheduled for quadrantectomy with or without axillary dissection

Exclusion Criteria

• pregnancy;
• body mass index (BMI) >35;
• allergy to local anesthetics;
• skeletal or muscle abnormalities of the chest wall;
• presence of primary or secondary neurological diseases;
• presence of psychiatric diseases;
• history of chronic pain or neuropathic disorders;
• history of drug abuse;
• state of sepsis;
• infection
• tumors of the skin on the chest;
• primary;
• secondary coagulopathies

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pecs II and parasternal blocks	Pecs II and parasternal blocks	Pecs II block was performed at the level of the fourth rib in the fascial plane between the minor pectoral and serratus anterior muscles, and 20 ml of 0.5% levobupivacaine solution were injected. An ultrasound-guided ipsilateral PaB was performed via two separate injections of 4 ml of 0.375% levobupivacaine at the level of the 2nd and 4th intercostal space underneath the external intercostal membrane between the major pectoral and intercostal muscles close to the surface of the 2nd and 4th rib.

Primary Outcome Measures

Name	Time	Method
Pain	Pain was recorded at 24 months after surgery	Pain has been evaluate with visual analogue scale (VAS) at 24 months after surgery

Secondary Outcome Measures

Name	Time	Method
Neuropathic postoperative disturbances	Neuropathic postoperative disturbances were recorded at 24 months after surgery	Neuropathic postoperative disturbances were examined using the von Frey hair test (neuropathic disturbances: present/not present) at 24 months
Patient satisfaction	Patient satisfaction was evaluated at 1 day after surgery	Patient satisfaction with regard to the anesthetic procedure was assessed using a five-step satisfaction scale (not at all/slightly/somewhat/very/extremely satisfied).
Woud healing	Wound healing was assessed at 24 months after surgery	Wound healing was assessed using a three-step scale (unacceptable/acceptable/excellent healing) in accordance with the surgeon's opinion.