RecruitingNot ApplicableNCT06889870

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.

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

Sponsor

Faculdade de Ciências Médicas de Minas Gerais

Enrollment

134 participants

Start Date

Apr 15, 2025

Study Type

INTERVENTIONAL

Conditions

Pain Pain Management Anesthesia

Summary

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study compares two regional anesthesia techniques — the PECS II block and local anesthetic infiltration — for controlling pain after breast cancer surgery. Both approaches numb specific nerves to reduce pain and lower the need for opioid painkillers. The study aims to find out which works better after this type of surgery. **You may be eligible if...** - You are a female patient between 18 and 80 years old - You are scheduled for unilateral (one-side) breast cancer surgery - Your overall health status is rated ASA I, II, or III (generally healthy to having manageable chronic conditions) **You may NOT be eligible if...** - You are pregnant - You have a BMI over 40 (morbid obesity) - You have cognitive impairment or communication difficulties - You have a bleeding or clotting disorder - You have a known allergy to local anesthetics - You have chronic pain or a history of drug addiction Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREPectoral 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.

PROCEDURELocal 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.