- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07724678
Comparison of Combined (Superficial and Deep) and Isolated Deep Serratus Anterior Plane Blocks After Breast Surgery
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
Study Overview
Status
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Ankara
-
Altındağ, Ankara, Turkey (Türkiye), 00000
- Ankara Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
Postoperative 24 hours.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total Tramadol Consumption
Time Frame: Postoperative 24 hours.
|
Total amount of tramadol consumed by the patient as rescue analgesia.
|
Postoperative 24 hours.
|
|
Need for rescue analgesia
Time Frame: Postoperative 24 hours.
|
Requirement for additional analgesic medications beyond the standard protocol.
|
Postoperative 24 hours.
|
|
Time to first rescue analgesia
Time Frame: Postoperative 24 hours.
|
Time elapsed from the end of surgery until the first request for rescue analgesia.
|
Postoperative 24 hours.
|
|
Postoperative nausea and vomiting (PONV) scores
Time Frame: Postoperative 24 hours.
|
Assessment of postoperative nausea and vomiting severity.
|
Postoperative 24 hours.
|
|
Patient satisfaction
Time Frame: Postoperative 24 hours.
|
Patient satisfaction level regarding the pain management technique.
|
Postoperative 24 hours.
|
|
Block-related complications
Time Frame: Postoperative 24 hours.
|
Incidence of potential complications related to the block technique (e.g., hematoma, infection, local anesthetic toxicity).
|
Postoperative 24 hours.
|
Collaborators and Investigators
Investigators
- Study Director: Meltem Bektas, Associate Professor, SBU Ankara Egitim ve Arastirma Hastanesi
- Principal Investigator: Dilara Hatice Arican, MD, SBU Ankara Egitim ve Arastirma Hastanesi
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- Pain
- Neurologic Manifestations
- Nervous System Diseases
- Postoperative Complications
- Pathologic Processes
- Neoplasms by Site
- Neoplasms
- Neurobehavioral Manifestations
- Skin Diseases
- Breast Diseases
- Perceptual Disorders
- Pathological Conditions, Signs and Symptoms
- Skin and Connective Tissue Diseases
- Signs and Symptoms
- Pain, Postoperative
- Breast Neoplasms
- Agnosia
Other Study ID Numbers
- E.25/447
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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