Evaluating The Efficacy Of Pecs II Blockade Compared To Local Anesthetic Infiltration In Controlling Postoperative Pain In Patients Undergoing Oncologic Breast Surgery Under Opioid Free/Sparing Anesthesia. (pain)

April 14, 2025 updated by: Alessandra Hubner de Souza, Faculdade de Ciências Médicas de Minas Gerais

PECS II Blockade vs. Local Anesthesia: Postoperative Pain Control in Opioid-Free Oncologic Breast Surgery

Breast cancer is the malignant neoplasm with the highest incidence in women in Brazil, with the exception of non-melanoma skin tumors. Breast cancer surgery is an important part of treatment and post-operative pain needs to be adequately prevented and treated. This prospective, randomized, double-blind clinical study aims to evaluate the efficacy of interfascial pectoral nerve block (PECS II) compared to local anesthetic infiltration at the surgical site in patients undergoing breast cancer surgery in terms of pain and nausea. Data collection will be carried out at the Nossa Senhora das Dores Hospital with 133 patients, who will be divided into two groups: the PEC group will undergo PECS II blockade and the LOC group will undergo local anesthetic infiltration at the surgical site. Both interventions will be performed after the induction of opioid-free/sparing balanced general anesthesia. At the end of surgery, the patients will be taken to the post-anesthetic recovery room (PACU), where post-operative pain will be monitored on arrival and at 30-minute intervals up to two hours after surgery, and before the patient is discharged the following day. A visual analog scale (VAS) will be used, and PONVs will also be recorded. After a 2-hour stay in the PACU, they will be transferred to the ward, and after 24 hours, they will be reassessed using the same parameters. Opioid consumption will be recorded in the PACU and during hospitalization, as well as the occurrence of nausea or vomiting and compared between the groups, and side effects and complications will be monitored.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Introduction:

Breast cancer is the most prevalent malignant neoplasm among women in Brazil, and oncologic surgery is an essential part of its treatment. Postoperative pain is a significant challenge, especially in approaches with general anesthesia. Methods such as PECS II blockade and infiltration of local anesthetics have been used for pain management and reduction of opioid consumption.

Objective:

The study aims to evaluate the effectiveness of the PECS II interfascial block in comparison with local anesthetic infiltration in controlling postoperative pain in patients undergoing breast oncology surgery under general anesthesia with minimal use of opioids (opioid-free/sparing).

Methodology:

This is a prospective, randomized, double-blind clinical trial involving 133 patients. They will be divided into two groups:

PEC group: will receive the PECS II block; LOC group: will be treated with local anesthetic infiltration at the surgical site.

Both interventions will take place after induction of anesthesia. The outcomes assessed include postoperative pain (using a visual analog scale - VAS), occurrence of nausea and vomiting (PONV), opioid consumption and side effects during 24 hours after surgery.

Conclusion:

The study aims to verify which anesthetic group provides less post-operative pain, less opioid consumption and greater patient well-being by not causing vomiting and nausea.

Study Type

Interventional

Enrollment (Estimated)

134

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • Minas Gerais
      • Itabira, Minas Gerais, Brazil
        • Recruiting
        • Hospital Nossa Senhora das Dores
        • Contact:
          • Alexandre José S Coelho - CEO do Hospital Nossa Senhora das Dores

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:Female patients aged between 18 and 80 years, ASA physical status I, II or III and undergoing unilateral surgery.

-

Exclusion Criteria: pregnant women, morbidly obese (BMI>40 kg/m²), patients with cognitive impairment or inability to communicate with the evaluator, coagulopathies, history of allergy to local anesthetics and patients with a history of chronic pain or drug addiction.

-

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: anesthetic infiltration at the surgical incision site group (LOC group)
In the LOC group, local infiltration will be carried out by the surgeon before the surgical incision. Adrenaline 1:20000 will be added to the anesthetic solution in the LOC group for the surgeon's convenience in order to better control perioperative bleeding
Procedure: Local Anesthesia
In the LOC group, local infiltration will be carried out by the surgeon before the surgical incision. Adrenaline 1:20000 will be added to the anesthetic solution in the LOC group for the surgeon's convenience in order to better control per operative bleeding. In the PEC group, a solution of adrenaline in the same concentration in 0.9% saline will be infiltrated, also just to control bleeding in the surgical field.
Experimental: PECS II blockade (PEC group)
In the PEC group, the PECS II block will be performed by the same anesthesiologist and will be performed before the skin incision, using the technique described by Blanco at al, 2012. A 10 ml solution of ropivacaine (0.3%) will be administered into the fascia between the pectoralis major and pectoralis minor muscles and 20 ml of the same anesthetic solution between the pectoralis minor and serratus muscles.
Procedure: Pectoral Nerve Block
In the PEC group, the PECS II block will be performed by the same anesthesiologist and will be performed before the skin incision, using the technique described by Blanco at al, 2012. 10 ml of ropivacaine solution (0.3%) will be administered into the fascia between the pectoralis major and pectoralis minor muscles and 20 ml of the same anesthetic solution between the pectoralis minor and serratus muscles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
opioid consumption
Time Frame: The visual analog scale (VAS) will be used to assess pain before surgery, in the PACU and after 24 hours, where 0 = no pain; 1-3 = mild pain; 4-6 = moderate pain; 7-10 = severe pain.
To compare opioid consumption in patients undergoing breast surgery under general anesthesia associated with PECS II blockade or local anesthetic infiltration in the per- and post-operative periods.
The visual analog scale (VAS) will be used to assess pain before surgery, in the PACU and after 24 hours, where 0 = no pain; 1-3 = mild pain; 4-6 = moderate pain; 7-10 = severe pain.

Collaborators and Investigators

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

Sponsor

Faculdade de Ciências Médicas de Minas Gerais

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

April 15, 2025

Primary Completion (Estimated)

March 30, 2026

Study Completion (Estimated)

July 30, 2026

Study Registration Dates

First Submitted

December 19, 2024

First Submitted That Met QC Criteria

March 17, 2025

First Posted (Actual)

March 21, 2025

Study Record Updates

Last Update Posted (Actual)

April 16, 2025

Last Update Submitted That Met QC Criteria

April 14, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FCMMG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

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