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AzTrials

PainpainNCT06889870

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.

A study testing Pectoral Nerve Block and Local Anesthesia in people with Pain and Pain Management, run by Faculdade de Ciências Médicas de Minas Gerais at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years, women onlyHealthy volunteers can take part
Conditions the study is for
Pain, Pain Management, Anesthesia
What is being tested?
Pectoral Nerve Block and Local Anesthesia
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
124 participants
Where
1 siteBrazil
Study dates
15 Apr 2025to 15 May 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

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.

-

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Hospital Nossa Senhora das Dores

    Itabira, Minas Gerais

Other trials in Brazil

About this study

Official title: 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.

Read the 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.

Being tested
Pectoral Nerve Block, Local Anesthesia
Keywords
ANESTHESIA, BREAST NEOPLASMS, NERVE BLOCK, OPIOID ANALGESICS
Medical subject headings
Pain, Agnosia, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pectoral Nerve BlockProcedure or surgery

    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 AnesthesiaProcedure or surgery

    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.

Study groups in NCT06889870
Study groupRoleWhat they receive
anesthetic infiltration at the surgical incision site group (LOC group)Active comparatorIn 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
Receives: Procedure: Local Anesthesia
PECS II blockade (PEC group)ExperimentalIn 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.
Receives: Procedure: Pectoral Nerve Block

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2025
  2. Study start15 Apr 2025
  3. Primary completion3 May 2026
  4. Study completion15 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, randomized, double-blind clinical trial
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06889870
Sponsor's protocol ID
FCMMG
Acronym
pain
Status last verified
Jun 2026
First submitted
19 Dec 2024
Last updated
9 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 37888041

  • 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.

    PubMed 30588080

  • 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.

    PubMed 33150677

  • 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.

    PubMed 37023374

Questions about this trial

What is this clinical trial studying?

A study testing Pectoral Nerve Block and Local Anesthesia in people with Pain and Pain Management, run by Faculdade de Ciências Médicas de Minas Gerais at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06889870, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.

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