Comparison of Combined (Superficial and Deep) and Isolated Deep Serratus Anterior Plane Blocks After Breast Surgery

Investigation of the Effectiveness of Ultrasonography-Guided Deep Serratus Anterior Plane Block and Combined Superficial and Deep Serratus Anterior Plane Block on Postoperative Pain in Patients Undergoing Modified Radical Mastectomy and Breast-Conserving Surgery

The main purpose of this study is to compare the effectiveness of two different regional anesthesia techniques for pain management after oncological breast surgeries. The researchers will compare the combined (superficial and deep) serratus anterior plane block with the deep serratus anterior plane block. The study aims to evaluate which method provides better postoperative pain relief, reduces the total consumption of opioid analgesics, and improves patient comfort

Study Overview

Study Type

Observational

Enrollment (Actual)

76

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

    • Ankara
      • Altındağ, Ankara, Turkey (Türkiye), 00000
        • Ankara Training and Research 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 undergoing elective modified radical mastectomy or breast-conserving surgery at SBU Ankara Egitim ve Arastirma Hastanesi

Description

Inclusion Criteria:

Patients aged 18-80 years.

Female patients with ASA physical status I, II, or III.

Patients scheduled for elective modified radical mastectomy or breast-conserving surgery.

Patients who provided written and verbal informed consent.

Exclusion Criteria:

Patients with ASA physical status IV-V.

Patients with a BMI ≥ 35 kg/m².

Patients with chronic pain, opioid/substance addiction, or long-term analgesic use.

Patients requiring emergency surgery.

Pregnant patients.

Known allergy to local anesthetics.

Severe cardiovascular, cerebrovascular, liver, or renal disease.

History of coagulopathy.

Infection at the injection site or systemic infection.

Patients who refuse the regional anesthesia technique, cannot speak the official language, or have mental disabilities/inability to cooperate.

Patients with a history of previous breast surgery or those scheduled for bilateral operations.

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
Combined Serratus Anterior Plane Block Group
Patients receiving both superficial and deep serratus anterior plane block
Isolated Deep Serratus Anterior Plane Block Group
Patients receiving only deep serratus anterior plane block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale (VAS) Scores for Postoperative Pain
Time Frame: Postoperative 24 hours.
Assessment of postoperative pain using the Visual Analog Scale (VAS) (minimum score: 0, maximum score: 10, where higher scores indicate worse outcome).
Postoperative 24 hours.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Tramadol Consumption
Time Frame: Postoperative 24 hours.
Total amount of tramadol consumed by the patient as rescue analgesia.
Postoperative 24 hours.
Need for rescue analgesia
Time Frame: Postoperative 24 hours.
Requirement for additional analgesic medications beyond the standard protocol.
Postoperative 24 hours.
Time to first rescue analgesia
Time Frame: Postoperative 24 hours.
Time elapsed from the end of surgery until the first request for rescue analgesia.
Postoperative 24 hours.
Postoperative nausea and vomiting (PONV) scores
Time Frame: Postoperative 24 hours.
Assessment of postoperative nausea and vomiting severity.
Postoperative 24 hours.
Patient satisfaction
Time Frame: Postoperative 24 hours.
Patient satisfaction level regarding the pain management technique.
Postoperative 24 hours.
Block-related complications
Time Frame: Postoperative 24 hours.
Incidence of potential complications related to the block technique (e.g., hematoma, infection, local anesthetic toxicity).
Postoperative 24 hours.

Collaborators and Investigators

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

Investigators

  • Study Director: Meltem Bektas, Associate Professor, SBU Ankara Egitim ve Arastirma Hastanesi
  • Principal Investigator: Dilara Hatice Arican, MD, SBU Ankara Egitim ve Arastirma Hastanesi

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)

April 21, 2025

Primary Completion (Actual)

January 28, 2026

Study Completion (Actual)

May 18, 2026

Study Registration Dates

First Submitted

July 17, 2026

First Submitted That Met QC Criteria

July 21, 2026

First Posted (Actual)

July 24, 2026

Study Record Updates

Last Update Posted (Actual)

July 24, 2026

Last Update Submitted That Met QC Criteria

July 21, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

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