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

NCT02865265 | Completed DMC

• 1 other identifier: 0109060/16
• Study Type: observational
• Target: 180
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Pain

  Pain has been evaluate with visual analogue scale (VAS) at 24 months after surgery

  Pain was recorded at 24 months after surgery

Secondary Outcomes (3)

• Neuropathic postoperative disturbances

  Neuropathic postoperative disturbances were recorded at 24 months after surgery

• Patient satisfaction

  Patient satisfaction was evaluated at 1 day after surgery

• Woud healing

  Wound healing was assessed at 24 months after surgery

Study Arms (1)

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.

Procedure: Pecs II and parasternal blocks

Interventions

Pecs II and parasternal blocks PROCEDURE

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 parasternal block 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.

Pecs II and parasternal blocks

Eligibility Criteria

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

Study Population

Patients scheduled for quadrantectomy with or without axillary dissection.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emiliano Petrucci: lead

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr Emiliano Petrucci

Study Record Dates

• First Submitted: August 4, 2016
• First Posted: August 12, 2016
• Study Start: March 1, 2013
• Primary Completion: March 1, 2013
• Study Completion: December 1, 2015
• Last Updated: August 12, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share