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NCT Number: NCT06889870

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.

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.

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Key information

Conditions

Pain Agnosia Anesthesia Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Management Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Nossa Senhora das Dores

Itabira, Minas Gerais, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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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.

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Treatment and study plan

pectoral nerve block

Procedure

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.

local anesthesia

Procedure

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Faculdade de Ciências Médicas de Minas Gerais

Other

Registry information

Official study title

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

Acronym: pain

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 21, 2025
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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