Comparison of PECS II Block and Combined Serratus Anterior Plane Block to Reduce Acute Pain After Mastectomy

April 10, 2025 updated by: Yusuf Özgüner, Ankara Etlik City Hospital

In this study, PECS II block or CSAB will be applied to patients who have had a modified radical mastectomy under general anesthesia for postoperative pain relief by using 30 ml of 0.25% bupivacaine .All patients will receive tramadol with a patient-controlled analgesia device during the postoperative period. Pain, nausea-vomiting, additional analgesic and antiemetic drug requirement, within 24 hours postoperatively will be compared between groups.

In this study, it was aimed to compare the efficacy of both peripheral nerve block methods in patients after mastectomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Breast cancer ranks first among the most common malignant neoplasms in women. Surgery has been a mainstay of breast cancer treatment for several decades and historically, a modified radical mastectomy was the primary method of treatment for breast cancer. Poorly controlled acute postoperative pain is associated with increased morbidity, functional and quality-of-life impairment. Additionally, severe acute postoperative pain is found to be a risk factor for chronic pain.

Thoracic paravertebral, thoracic epidural, intercostal nerve, and interscalene brachial plexus blocks have been used for anesthesia and abirritation during modified radical mastectomy, but their application is limited due to the complex nature of the procedures and serious complications. There is growing interest in the pectoralis nerve (PECS) blocks and serratus anterior block (SAB) which are less invasive as an analgesic technique during breast surgeries to reduce postoperative pain.

The Pecs I block is a single injection of local anaesthetic between pectoralis major and pectoralis minor muscles at the level of the 3rd rib to anaesthetise the lateral and medial pectoral nerves. The Pecs II block is a modified Pecs I block and can be achieved with one needle insertion point. Local anaesthetic is placed between pectorals major and minor as for a Pecs I block and then between pectoralis minor and serratus anterior muscles.

Numerous clinical studies focusing on the analgesic potential of PECS block in breast augmentation surgery, small breast surgery and breast cancer surgery have yielded positive results. SAD is more superficial, easy to access and less likely to have complications like PECS block. SAPB can be implemented in two ways. Deep SAB (DSAB) is applied under the serratus anterior muscle, while superficial SAB (YSAB) is applied over the serratus anterior muscle. In recent years, deep and superficial SAB, that is, combined SAB (CSAB), has been started to be applied in order to increase the effect area of local anesthetics and to prevent block failure.

In this study, PECS II block or CSAB will be applied to patients who have had a modified radical mastectomy under general anesthesia for postoperative pain relief by using 30 ml of 0.25% bupivacaine .All patients will receive tramadol with a patient-controlled analgesia device during the postoperative period. Pain, nausea-vomiting, additional analgesic and antiemetic drug requirement, within 24 hours postoperatively will be compared between groups.

In this study, it was aimed to compare the efficacy of both peripheral nerve block methods in patients after mastectomy.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Varlık Mahallesi, Halil Sezai Erkut Caddesi Yenimahalle
      • Ankara, Varlık Mahallesi, Halil Sezai Erkut Caddesi Yenimahalle, Turkey, 06170
        • Ankara Etlik City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients who undergone mastectomy surgery

Description

Inclusion Criteria:

  • Patients between the ages of 18-80
  • Patients with ASA score I-II-III
  • Patients with a body mass index (BMI) between 18 and 40
  • Patients who underwent PECS-II block or CSAB with mastectomy in the operating room

Exclusion Criteria:

  • Patients under the age of 18 and over the age of 80
  • Patients with an ASA score of IV and above
  • Patients with advanced co-morbidity
  • Patients with a history of bleeding diathesis
  • Patients who have infection in the area which is to be blocked
  • BMI below 18 and over 40
  • Patients undergoing emergency surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with PECS II Block
PECS 2 block will be applied to patients in this group.
Other: PECS II Block
The Pecs II block is applied to the patients after induction of anesthesia .
Patients with Combined Serratus Anterior Plane Block
Combined Serratus Anterior Plane Block will be applied to patients in this group.
Other: Combined Serratus Anterior Plane Block
Combined Serratus Anterior Plane Block is applied to the patients after induction of anesthesia .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain on the Numeric Rating Scale (NRS)
Time Frame: 0 hours postoperatively
Participants recorded pain rated on the numeric rating scale (NRS) at 6 time points. NRS range was from 0-10 with 0 being no pain and 10 the worst pain possible.
0 hours postoperatively
Pain on the Numeric Rating Scale (NRS)
Time Frame: 2 hours postoperatively
Participants recorded pain rated on the numeric rating scale (NRS) at 6 time points. NRS range was from 0-10 with 0 being no pain and 10 the worst pain possible.
2 hours postoperatively
Pain on the Numeric Rating Scale (NRS)
Time Frame: 4 hours postoperatively
Participants recorded pain rated on the numeric rating scale (NRS) at 6 time points. NRS range was from 0-10 with 0 being no pain and 10 the worst pain possible.
4 hours postoperatively
Pain on the Numeric Rating Scale (NRS)
Time Frame: 8 hours postoperatively
Participants recorded pain rated on the numeric rating scale (NRS) at 6 time points. NRS range was from 0-10 with 0 being no pain and 10 the worst pain possible.
8 hours postoperatively
Pain on the Numeric Rating Scale (NRS)
Time Frame: 12 hours postoperatively
Participants recorded pain rated on the numeric rating scale (NRS) at 6 time points. NRS range was from 0-10 with 0 being no pain and 10 the worst pain possible.
12 hours postoperatively
Pain on the Numeric Rating Scale (NRS)
Time Frame: 24 hours postoperatively
Participants recorded pain rated on the numeric rating scale (NRS) at 6 time points. NRS range was from 0-10 with 0 being no pain and 10 the worst pain possible.
24 hours postoperatively
Total opioid consumption
Time Frame: 24 hours postoperatively
All patients will receive tramadol with a patient-controlled analgesia device during the postoperative period.
24 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara Etlik City Hospital

Investigators

  • Principal Investigator: Yusuf Ozguner, Ankara Etlik City Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2023

Primary Completion (Actual)

November 1, 2023

Study Completion (Actual)

June 1, 2024

Study Registration Dates

First Submitted

July 14, 2023

First Submitted That Met QC Criteria

July 23, 2023

First Posted (Actual)

July 27, 2023

Study Record Updates

Last Update Posted (Actual)

April 11, 2025

Last Update Submitted That Met QC Criteria

April 10, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AnkaraEtlikYusufOzguner004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain, Postoperative

Clinical Trials on PECS II Block

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in France

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe