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.

NCT06889870 | Recruiting DMC

• 1 other identifier: FCMMG
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain; Pain Management; Anesthesia

Keywords

ANESTHESIA; BREAST NEOPLASMS; NERVE BLOCK; OPIOID ANALGESICS

Outcome Measures

Primary Outcomes (1)

• opioid consumption

  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.

Study Arms (2)

anesthetic infiltration at the surgical incision site group (LOC group)

ACTIVE COMPARATOR

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

PECS II blockade (PEC group)

EXPERIMENTAL

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

Interventions

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.

PECS II blockade (PEC group)

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.

anesthetic infiltration at the surgical incision site group (LOC group)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Faculdade de Ciências Médicas de Minas Gerais: lead

Study Sites (1)

Hospital Nossa Senhora das Dores

Itabira, Minas Gerais, Brazil

RECRUITING

Related Publications (4)

• Cylwik J, Celinska-Spodar M, Buda N. Evaluation of the Efficacy of Pectoral Nerve-2 Block (PECS 2) in Breast Cancer Surgery. J Pers Med. 2023 Sep 24;13(10):1430. doi: 10.3390/jpm13101430.

  PMID: 37888041 BACKGROUND

• Bakeer AH, Abdallah NM, Kamel MA, Abbas DN, Ragab AS. The impact of intravenous dexamethasone on the efficacy and duration of analgesia of paravertebral block in breast cancer surgery: a randomized controlled trial. J Pain Res. 2018 Dec 19;12:61-67. doi: 10.2147/JPR.S181788. eCollection 2019.

  PMID: 30588080 BACKGROUND

• Bi Y, Ye Y, Zhu Y, Ma J, Zhang X, Liu B. The Effect of Ketamine on Acute and Chronic Wound Pain in Patients Undergoing Breast Surgery: A Meta-Analysis and Systematic Review. Pain Pract. 2021 Mar;21(3):316-332. doi: 10.1111/papr.12961. Epub 2020 Nov 13.

  PMID: 33150677 BACKGROUND

• Badwe RA, Parmar V, Nair N, Joshi S, Hawaldar R, Pawar S, Kadayaprath G, Borthakur BB, Rao Thammineedi S, Pandya S, Balasubramanian S, Chitale PV, Neve R, Harris C, Srivastava A, Siddique S, Vanmali VJ, Dewade A, Gaikwad V, Gupta S. Effect of Peritumoral Infiltration of Local Anesthetic Before Surgery on Survival in Early Breast Cancer. J Clin Oncol. 2023 Jun 20;41(18):3318-3328. doi: 10.1200/JCO.22.01966. Epub 2023 Apr 6.

  PMID: 37023374 BACKGROUND

MeSH Terms

Conditions

Pain; Agnosia; Breast Neoplasms

Interventions

Anesthesia, Local

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Central Study Contacts

Alessandra H De Souza, PhD

CONTACT

55-31984205240; alessandra.souza@cienciasmedicasmg.edu.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double-blind \- both the researcher and those taking part in the study do not know which intervention each participant is receiving is receiving
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Main supervisor of the study, statistical analyst and specialist in pain studies; pHd IN pHARMACOLOGICAL SCIENCES

Model Details: Prospective, randomized, double-blind clinical trial

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: March 21, 2025
• Study Start: April 15, 2025
• Primary Completion: March 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: April 16, 2025

Record last verified: 2025-02

Locations

BR (1)