Postoperative Pain ControlNCT06905574
Surgeon-Guided Serratus Block in Breast Reduction Surgery
A study testing surgeon guided serratus block in people with Postoperative Pain Control and Breast Reduction, run by alperen can kokten at 1 site in Turkey (Türkiye).
Trial summary
Surgeon guided serratus block, which can be performed by the surgeon in participants undergoing breast reduction surgery, may reduce the sensation of pain from the surgical field in the postoperative period. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain Control, Breast Reduction
- What is being tested?
- surgeon guided serratus block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2024to 31 Oct 2025
- Phase
- Interventional
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient's willingness to be included in the study
- 18-65 years
- Woman
- Operated with inferior pedicled breast reduction technique
- The distance from the sternal notch to the nipple complex is between 25-40cm
- ASA I-II
- Breast Usg result BIRADS 1-2
- Patients who have not previously received RT to the breast and have no history of malignancy
Who cannot join
- Patient's request/refusal not to be included in the study
- Previous history of malignancy
- RT story,
- ASA 3-4-5-patient group
- Severe organ failure
- Alcohol, drug addiction
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- Bupivacaine allergy
- Diagnosis of psychiatric illness and psychiatric drug use
- Surgery lasting longer than 3 hours
- Bleeding diathesis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Samsun training and research hospital
Samsun, 55020
About this study
Official title: Postoperative Analgesic Efficacy of Intraoperative Surgeon-Guided Serratus Block: A Prospective Randomized Study
Surgeon guided serratus block, which can be performed by the surgeon in participants undergoing breast reduction surgery, may reduce the sensation of pain from the surgical field in the postoperative period. Thus, participants experience less pain in the postoperative period, consume less analgesics, and there is a decrease in related complications. The aim of this study was to evaluate the effects of the intraoperative surgeon guided serratus block applied on the analgesic consumption of the participants in the first 24 hours after surgery in participants undergoing breast reduction surgery.
- Conditions
- Postoperative Pain Control, Breast Reduction
- Being tested
- surgeon guided serratus block
- Keywords
- breast reduction, postoperative pain control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgeon guided serratus blockOther
Surgeon guided Serratus Block will be applied before closing dermoglandular flaps
| Study group | Role | What they receive |
|---|---|---|
| Group Control | No intervention | No intervention will be made in this group. |
| Group SSPB | Experimental | Surgeon guided serratus block will be applied before closing dermoglandular flaps Receives: Other: surgeon guided serratus block |
What is being measured
The primary outcome is the main question the study is designed to answer.
24 hours postoperatively opioid consumption
In the postoperative period, patients will be given opioids according to their pain density with a patient-controlled device, and the daily Morphine consumption in Patient Controlled Analgesia device will be collected and compared between groups.
Measured: 24 hours
Secondary outcomes (1)
post-operative acute pain status, post-operative nausea-vomiting status, post-operative NRS determination of pain at rest and in motion determination of complications such as nausea, vomiting, itching, determination of the first PCA analgesic request.
Changes in the Numerical Rating Scale (NRS) will be recorded at rest and during movement. The participant's baseline NRS will be recorded, followed by measurements before and after neuraxial positioning and up to 24 hours post-surgery. The NRS is a unidimensional measure of pain intensity in adults. The 11-point numerical scale ranges from '0' representing one end of the pain spectrum (e.g. 'no pain') to '10' representing the other end (e.g. 'worst imaginable pain').
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start1 Dec 2024
- Primary completion30 Oct 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain ControlStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- alperen can kokten
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, alperen can kokten, Samsun University
- Investigators
- Ayhan Sönmez, Study director, SAMSUN UNİVERSİTY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06905574
- Sponsor's protocol ID
- SGSB-01
- Other IDs
- SamsunU
- Status last verified
- Jan 2026
- First submitted
- 10 Feb 2025
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Analgesic Efficacy of Intraoperative Surgeon-Guided Serratus Block: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT06905574
- Acronym / sponsor ID
- SGSB-01
- Conditions
- Postoperative Pain Control, Breast Reduction
- Keywords
- breast reduction, postoperative pain control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- alperen can koktenUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 1 Apr 2025 (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.
Surgeon guided serratus block, which can be performed by the surgeon in participants undergoing breast reduction surgery, may reduce the sensation of pain from the surgical field in the postoperative period. Thus, participants experience less pain in the postoperative period, consume less analgesics, and there is a decrease in related complications. The aim of this study was to evaluate the effects of the intraoperative surgeon guided serratus block applied on the analgesic consumption of the participants in the first 24 hours after surgery in participants undergoing breast reduction surgery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Control | No intervention | –No intervention will be made in this group. |
| Group SSPB | Experimental | Other: surgeon guided serratus blockSurgeon guided serratus block will be applied before closing dermoglandular flaps |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient's willingness to be included in the study
- 18-65 years
- Woman
- Operated with inferior pedicled breast reduction technique
- The distance from the sternal notch to the nipple complex is between 25-40cm
Key exclusion criteria (10 listed)
- Patient's request/refusal not to be included in the study
- Previous history of malignancy
- RT story,
- ASA 3-4-5-patient group
- Severe organ failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgeon guided serratus blockSurgeon guided Serratus Block will be applied before closing dermoglandular flaps | Other | Group SSPB |
Primary outcome
24 hours postoperatively opioid consumption
Time frame: 24 hours
In the postoperative period, patients will be given opioids according to their pain density with a patient-controlled device, and the daily Morphine consumption in Patient Controlled Analgesia device will be collected and compared between groups.
1 secondary outcome
post-operative acute pain status, post-operative nausea-vomiting status, post-operative NRS determination of pain at rest and in motion determination of complications such as nausea, vomiting, itching, determination of the first PCA analgesic request.
Time frame: 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 29 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Ayhan Sönmez study director
SAMSUN UNİVERSİTY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing surgeon guided serratus block in people with Postoperative Pain Control and Breast Reduction, run by alperen can kokten 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 8 inclusion and 10 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 29 Jan 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?
24 hours postoperatively opioid consumption (time frame: 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 29 Jan 2026.