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

August 9, 2016 updated by: Emiliano Petrucci

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

180

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Patients scheduled for quadrantectomy with or without axillary dissection.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: Pain was recorded at 24 months after surgery
Pain has been evaluate with visual analogue scale (VAS) at 24 months after surgery
Pain was recorded at 24 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neuropathic postoperative disturbances
Time Frame: 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
Neuropathic postoperative disturbances were recorded at 24 months after surgery
Patient satisfaction
Time Frame: 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).
Patient satisfaction was evaluated at 1 day after surgery
Woud healing
Time Frame: 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.
Wound healing was assessed at 24 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

August 4, 2016

First Submitted That Met QC Criteria

August 9, 2016

First Posted (Estimate)

August 12, 2016

Study Record Updates

Last Update Posted (Estimate)

August 12, 2016

Last Update Submitted That Met QC Criteria

August 9, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 0109060/16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on Pecs II and parasternal blocks

3
Subscribe