Breast CancerNCT07724678
Comparison of Combined (Superficial and Deep) and Isolated Deep Serratus Anterior Plane Blocks After Breast Surgery
An observational study of Breast Cancer and Postoperative Pain, run by SBU Ankara Egitim ve Arastirma Hastanesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer, Postoperative Pain, Pain Management After Surgery
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Apr 2025to 18 May 2026
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing elective modified radical mastectomy or breast-conserving surgery at SBU Ankara Egitim ve Arastirma Hastanesi
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Training and Research Hospital
Altındağ, Ankara, 00000
About this study
Official title: 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
- Keywords
- Serratus Anterior Plane Block, Regional Anesthesia, Bupivacaine, Breast Surgery, Analgesia
- Medical subject headings
- Breast Neoplasms, Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Postoperative 24 hours.
Secondary outcomes (6)
Total Tramadol Consumption
Total amount of tramadol consumed by the patient as rescue analgesia.
Measured: Postoperative 24 hours.
Need for rescue analgesia
Requirement for additional analgesic medications beyond the standard protocol.
Measured: Postoperative 24 hours.
Time to first rescue analgesia
Time elapsed from the end of surgery until the first request for rescue analgesia.
Measured: Postoperative 24 hours.
Postoperative nausea and vomiting (PONV) scores
Assessment of postoperative nausea and vomiting severity.
Measured: Postoperative 24 hours.
Patient satisfaction
Patient satisfaction level regarding the pain management technique.
Measured: Postoperative 24 hours.
Block-related complications
Incidence of potential complications related to the block technique (e.g., hematoma, infection, local anesthetic toxicity).
Measured: Postoperative 24 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start21 Apr 2025
- Primary completion28 Jan 2026
- Study completion18 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- SBU Ankara Egitim ve Arastirma Hastanesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cemre Kahya Ozgunalp, SBU Ankara Egitim ve Arastirma Hastanesi
- Investigators
- Meltem Bektas, Associate Professor, Study director, SBU Ankara Egitim ve Arastirma HastanesiDilara Hatice Arican, MD, Study director, SBU Ankara Egitim ve Arastirma HastanesiCemre Kahya Özgünalp, MD, Principal investigator, SBU Ankara Egitim ve Arastirma Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07724678
- Sponsor's protocol ID
- E.25/447
- Status last verified
- Jul 2026
- First submitted
- 17 Jul 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07724678
- Acronym / sponsor ID
- E.25/447
- Keywords
- Serratus Anterior Plane Block, Regional Anesthesia, Bupivacaine, Breast Surgery, Analgesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- SBU Ankara Egitim ve Arastirma HastanesiUniversity, hospital or other
- Study start
- 21 Apr 2025 (actual)
- Primary completion
- 28 Jan 2026 (actual)
- Study completion
- 18 May 2026 (actual)
- First posted
- 24 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective modified radical mastectomy or breast-conserving surgery at SBU Ankara Egitim ve Arastirma Hastanesi
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
6 secondary outcomes
Total Tramadol Consumption
Time frame: Postoperative 24 hours.
Need for rescue analgesia
Time frame: Postoperative 24 hours.
Time to first rescue analgesia
Time frame: Postoperative 24 hours.
Postoperative nausea and vomiting (PONV) scores
Time frame: Postoperative 24 hours.
Patient satisfaction
Time frame: Postoperative 24 hours.
Block-related complications
Time frame: Postoperative 24 hours.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meltem Bektas, Associate Professor study director
SBU Ankara Egitim ve Arastirma Hastanesi
Dilara Hatice Arican, MD study director
SBU Ankara Egitim ve Arastirma Hastanesi
Cemre Kahya Özgünalp, MD principal investigator
SBU Ankara Egitim ve Arastirma Hastanesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Postoperative Pain, run by SBU Ankara Egitim ve Arastirma Hastanesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. 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 4 Sep 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 Turkey (Türkiye). 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?
Visual Analog Scale (VAS) Scores for Postoperative Pain (time frame: Postoperative 24 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Sep 2026.