NCT07394868

Brief Summary

Breast cancer is the most common malignancy in women; surgery is a cornerstone of breast cancer treatment, and modified radical mastectomy is one of the standard treatments. Postoperative pain can significantly reduce the quality of life in patients, and acute pain can even trigger chronic pain syndrome. Thoracic paravertebral, thoracic epidural, intercostal nerve, and interscalene brachial plexus blocks have been used for anesthesia and abiration during modified radical mastectomy, but their application is limited due to the complex nature of the procedures and serious complications. In recent years, there has been increasing interest in the newer, less invasive superficial serratus block and combined serratus block. Serratus anterior plane block (SAPB) can be applied in two ways. Deep SPB (DSPB) is applied under the serratus anterior muscle, while superficial SPB (YSPB) is applied above the serratus anterior muscle. In recent years, deep + superficial SPB, or combined SPB (KSPB), has begun to be applied in order to increase the area of effect of local anesthetics and to prevent block failure. This study aims to compare superficial and combined serratus anterior plane blocks.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
2mo left

Started Feb 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Feb 2026Aug 2026

First Submitted

Initial submission to the registry

January 31, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 6, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

February 15, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2026

Last Updated

February 11, 2026

Status Verified

February 1, 2026

Enrollment Period

5 months

First QC Date

January 31, 2026

Last Update Submit

February 7, 2026

Conditions

Keywords

Breast surgeryMultimodal analgesiaSerratus anterior plane block

Outcome Measures

Primary Outcomes (1)

  • Opioid consumption

    Patients will be monitored for 24-hour opioid consumption with patient-controlled analgesia.

    24 hours postoperative

Secondary Outcomes (6)

  • Numeric Rating Scale (NRS)

    1 hour

  • Numeric Rating Scale (NRS)

    2 hour

  • Numeric Rating Scale (NRS)

    4 hour

  • Numeric Rating Scale (NRS)

    12 hour

  • Numeric Rating Scale (NRS)

    24 hour

  • +1 more secondary outcomes

Study Arms (2)

Combined superficial and deep serratus anterior plane block

Patients who will undergo combined serratus anterior plane block will be included in this group.

Other: Combined serratus plan block

Superficial serratus anterior plane block

Patients who will undergo a superficial anterior plane serratus block will be included in this group.

Other: Superficial serratus plane block

Interventions

Combined serratus plan block

Combined superficial and deep serratus anterior plane block

Superficial serratus plane block

Superficial serratus anterior plane block

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who undergone mastectomy surgery

You may qualify if:

  • Individuals aged 18-80 years
  • Individuals with ASA scores I-II-III
  • Individuals with a Body Mass Index (BMI) between 18-40

You may not qualify if:

  • Individuals under 18 years of age and over 80 years of age
  • Individuals with an ASA score of IV or higher
  • Individuals with advanced comorbidities
  • Individuals with a history of bleeding diathesis
  • Patients with infection in the area to be blocked
  • Individuals with a BMI below 18 and above 40

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Etlik City Hospital

Ankara, Varlık Mahallesi, Halil Sezai Erkut Caddesi Yenimahalle, 06170, Turkey (Türkiye)

Location

Related Publications (3)

  • Chai B, Wang Q, Du J, Chen T, Qian Y, Zhu Z, Feng Z, Kang X. Research Progress on Serratus Anterior Plane Block in Breast Surgery: A Narrative Review. Pain Ther. 2023 Apr;12(2):323-337. doi: 10.1007/s40122-022-00456-z. Epub 2022 Dec 9.

    PMID: 36484891BACKGROUND
  • Ozguner Y, Yazar CO, Aydin F, Zengin M, Arik E, Kotanoglu MS, Altinsoy S, Ergil J. Comparison of the analgesic efficacy of combined superficial and deep serratus anterior plane block versus pectoserratus plane block following modified radical mastectomy surgery. BMC Anesthesiol. 2025 Jul 28;25(1):358. doi: 10.1186/s12871-025-03213-9.

  • Ulger G, Zengin M, Kucuk O, Baldemir R, Kaybal O, Tunc M, Sazak H, Alagoz A. Comparison of combined deep and superficial serratus anterior block with thoracic paravertebral block for postoperative pain in patients undergoing video-assisted thoracoscopic surgery. Turk J Med Sci. 2024 Aug 4;54(5):1021-1032. doi: 10.55730/1300-0144.5881. eCollection 2024.

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Yusuf Ozguner

    Ankara Etlik City Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 31, 2026

First Posted

February 6, 2026

Study Start

February 15, 2026

Primary Completion (Estimated)

July 15, 2026

Study Completion (Estimated)

August 15, 2026

Last Updated

February 11, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations