- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06905574
Surgeon-Guided Serratus Block in Breast Reduction Surgery
January 28, 2026 updated by: alperen can kokten
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
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
-
-
-
Samsun, Turkey (Türkiye), 55020
- Samsun 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
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Bupivacaine allergy
- Diagnosis of psychiatric illness and psychiatric drug use
- Surgery lasting longer than 3 hours
- Bleeding diathesis
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
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Group Control
No intervention will be made in this group.
|
|
|
Experimental: Group SSPB
Surgeon guided serratus block will be applied before closing dermoglandular flaps
|
Surgeon guided Serratus Block will be applied before closing dermoglandular flaps
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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').
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Ayhan Sönmez, Samsun University
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)
December 1, 2024
Primary Completion (Actual)
October 30, 2025
Study Completion (Actual)
October 31, 2025
Study Registration Dates
First Submitted
February 10, 2025
First Submitted That Met QC Criteria
March 25, 2025
First Posted (Actual)
April 1, 2025
Study Record Updates
Last Update Posted (Actual)
January 29, 2026
Last Update Submitted That Met QC Criteria
January 28, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SGSB-01
- SamsunU (Other Identifier: Samsun university)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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