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

Breast Cancer Clinical Trial

Official title:

Association Between Ultrasound-guided Pecs II Block and Parasternal Block May Represent a Valid Alternative for the Management of Acute and Postoperative Pain Syndrome in Breast Cancer Surgery: a Retrospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02865265
• Other study ID #: 0109060/16
• Status: Completed
• Phase: N/A
• First received: August 4, 2016
• Last updated: August 9, 2016
• Start date: March 2013
• Est. completion date: December 2015

Study information

• Verified date: August 2016
• Source: San Salvatore Hospital of L'Aquila
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: December 2015
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• 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 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Emiliano Petrucci

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain	Pain has been evaluate with visual analogue scale (VAS) at 24 months after surgery	Pain was recorded at 24 months after surgery	Yes
Secondary	Neuropathic postoperative disturbances	Neuropathic postoperative disturbances were examined using the von Frey hair test (neuropathic disturbances: present/not present) at 24 months	Neuropathic postoperative disturbances were recorded at 24 months after surgery	Yes
Secondary	Patient satisfaction	Patient satisfaction with regard to the anesthetic procedure was assessed using a five-step satisfaction scale (not at all/slightly/somewhat/very/extremely satisfied).	Patient satisfaction was evaluated at 1 day after surgery	Yes
Secondary	Woud healing	Wound healing was assessed using a three-step scale (unacceptable/acceptable/excellent healing) in accordance with the surgeon's opinion.	Wound healing was assessed at 24 months after surgery	Yes