NCT07724678

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

April 21, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 18, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 24, 2026

Completed
Last Updated

July 24, 2026

Status Verified

July 1, 2026

Enrollment Period

9 months

First QC Date

July 17, 2026

Last Update Submit

July 21, 2026

Conditions

Keywords

Serratus Anterior Plane BlockRegional AnesthesiaBupivacaineBreast SurgeryAnalgesia

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Scale (VAS) Scores for Postoperative Pain

    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 Outcomes (6)

  • Total Tramadol Consumption

    Postoperative 24 hours.

  • Need for rescue analgesia

    Postoperative 24 hours.

  • Time to first rescue analgesia

    Postoperative 24 hours.

  • Postoperative nausea and vomiting (PONV) scores

    Postoperative 24 hours.

  • Patient satisfaction

    Postoperative 24 hours.

  • +1 more secondary outcomes

Study Arms (2)

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

Eligibility Criteria

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

Patients undergoing elective modified radical mastectomy or breast-conserving surgery at SBU Ankara Egitim ve Arastirma Hastanesi

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Training and Research Hospital

Altındağ, Ankara, 00000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast NeoplasmsPain, PostoperativeAgnosia

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Officials

  • Meltem Bektas, Associate Professor

    SBU Ankara Egitim ve Arastirma Hastanesi

    STUDY DIRECTOR
  • Dilara Hatice Arican, MD

    SBU Ankara Egitim ve Arastirma Hastanesi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2026

First Posted

July 24, 2026

Study Start

April 21, 2025

Primary Completion

January 28, 2026

Study Completion

May 18, 2026

Last Updated

July 24, 2026

Record last verified: 2026-07

Locations