Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
FEMALE
Healthy Volunteers
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.

Led by Faculdade de Ciências Médicas de Minas Gerais · Updated on 2025-04-16

134

Participants Needed

1

Research Sites

67 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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.

Who Can Participate

Age: 18Years - 80Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Female patients aged between 18 and 80 years
  • ASA physical status I, II, or III
  • Undergoing unilateral breast cancer surgery
Not Eligible

You will not qualify if you...

  • Pregnant women
  • Morbid obesity (BMI greater than 40 kg/m²)
  • Cognitive impairment or inability to communicate with the evaluator
  • Coagulopathies
  • Allergy to local anesthetics
  • History of chronic pain or drug addiction

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hospital Nossa Senhora das Dores

Itabira, Minas Gerais, Brazil

Actively Recruiting

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Research Team

A

Alessandra H De Souza, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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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. | DecenTrialz