- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07394868
Comparison of the Combined Serratus Anterior Plane Block Versus Superficial Serratus Anterior Plane Block
Comparison of the Analgesic Efficacy of Combined Superficial and Deep Serratus Anterior Plane Block Versus Superficial Serratus Anterior Plane Block Following Modified Radical Mastectomy Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Yusuf Ozguner
- Phone Number: 05427150725
- Email: y.ozguner@hotmail.com
Study Locations
-
-
Varlık Mahallesi, Halil Sezai Erkut Caddesi Yenimahalle
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Ankara, Varlık Mahallesi, Halil Sezai Erkut Caddesi Yenimahalle, Turkey (Türkiye), 06170
- Ankara Etlik City Hospital
-
Contact:
- Yusuf Ozguner
- Phone Number: +903127970000
- Email: etliksh.iletisim@saglik.gov.tr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Individuals aged 18-80 years
- Individuals with ASA scores I-II-III
- Individuals with a Body Mass Index (BMI) between 18-40
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Combined superficial and deep serratus anterior plane block
Patients who will undergo combined serratus anterior plane block will be included in this group.
|
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.
|
Superficial serratus plane block
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Opioid consumption
Time Frame: 24 hours postoperative
|
Patients will be monitored for 24-hour opioid consumption with patient-controlled analgesia.
|
24 hours postoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric Rating Scale (NRS)
Time Frame: 1 hour
|
NRS is a scoring system ranging from 0 to 10, where higher values indicate a higher degree of pain. Pain level assessed by Numeric Rating Scale (NRS) in the first 24 hours postoperatively, pain at 1 hour, 2, 4, 12, and 24 hours, and pain with rest and coughing. |
1 hour
|
|
Numeric Rating Scale (NRS)
Time Frame: 2 hour
|
NRS is a scoring system ranging from 0 to 10, where higher values indicate a higher degree of pain. Pain level assessed by Numeric Rating Scale (NRS) in the first 24 hours postoperatively, pain at 1 hour, 2, 4, 12, and 24 hours, and pain with rest and coughing. |
2 hour
|
|
Numeric Rating Scale (NRS)
Time Frame: 4 hour
|
NRS is a scoring system ranging from 0 to 10, where higher values indicate a higher degree of pain. Pain level assessed by Numeric Rating Scale (NRS) in the first 24 hours postoperatively, pain at 1 hour, 2, 4, 12, and 24 hours, and pain with rest and coughing. |
4 hour
|
|
Numeric Rating Scale (NRS)
Time Frame: 12 hour
|
NRS is a scoring system ranging from 0 to 10, where higher values indicate a higher degree of pain. Pain level assessed by Numeric Rating Scale (NRS) in the first 24 hours postoperatively, pain at 1 hour, 2, 4, 12, and 24 hours, and pain with rest and coughing. |
12 hour
|
|
Numeric Rating Scale (NRS)
Time Frame: 24 hour
|
NRS is a scoring system ranging from 0 to 10, where higher values indicate a higher degree of pain. Pain level assessed by Numeric Rating Scale (NRS) in the first 24 hours postoperatively, pain at 1 hour, 2, 4, 12, and 24 hours, and pain with rest and coughing. |
24 hour
|
|
Patient satisfaction score
Time Frame: 24 hour
|
Patient satisfaction will be evaluated using a 5-point Likert scale at 24 hours postoperatively. A Likert scale is a system of scores ranging from 1 to 5, where 1 (not satisfied at all) and 5 (very satisfied). |
24 hour
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yusuf Ozguner, Ankara Etlik City Hospital
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Etlik Kübra Tez
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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