- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06407037
Comparison of Erector Spinae Plane Block and Serratus Posterior Superior Intercostal Plane Block
March 11, 2025 updated by: Emine Arik, Diskapi Yildirim Beyazit Education and Research Hospital
Comparison of the Effects of Ultrasound-Guided Erector Spinae Plane Block and Serratus Posterior Superior Intercostal Plane Block on Postoperative Acute Pain in Patients Undergoing Breast Surgery
Breast cancer is the most common malignancy in women.
Modified radical mastectomy, a surgical procedure in the treatment of breast cancer, is one of the standard treatments.
Postoperative pain can seriously reduce the quality of life in patients, and inadequately treated acute pain can trigger chronic pain syndrome.
Therefore, thoracic paravertebral block and thoracic epidural block are effective in postoperative analgesia.
However, the use of these blocks is limited due to complications.
In recent years, less invasive blocks, such as pectoral nerve block (PECS I-II), Serratus anterior plane block (SAPB), Erector spinae plane block (ESPB), and Serratus Posterior Superior intercostal Plane Block (SPSİPB) have been applied.
In this study, it was aimed to compare the analgesic effectiveness of ESPB and SPSİPB applications in patients undergoing breast surgery.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Postoperative pain will be assessed during resting and coughing with a visual analog scale (0-10 cm) and nausea and vomiting with a Postoperative Nausea Vomiting Score at the postoperative 1, 4, 8, 12, and 24 hours.
The amount of tramadol consumed in the postoperative period will be recorded.
Patient satisfaction will be assessed with the Likert scale at postoperative 24 hours.
Study Type
Interventional
Enrollment (Actual)
50
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
-
-
Ankara
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Yenimahalle, Ankara, Turkey, 06170
- Ankara Etlik City 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
No
Description
Inclusion Criteria:
- Those aged 18-65
- Those with ASA scores I-II-III
- Those with a body mass index (BMI) between 18-35
- Patients who will undergo breast surgery
Exclusion Criteria:
- Those under the age of 18 and over the age of 65
- Those with ASA score IV and above
- Those with a history of allergy to the drugs to be blocked
- Those with a history of bleeding diathesis
- Patients with infection in the area to be blocked
- Those with a BMI below 18 and above 35
- Patients who underwent surgery under emergency conditions
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Erector Spinae Plane Block
Following the visualization of the anatomical structures, the nerve block needle was advanced via the in-plane technique beneath the erector spinae muscles until the interfascial space was reached.
After hydrodissection with 2 ml normal saline, 30 ml of 0.25% bupivacaine was injected into the area.
|
Erector Spinae Plane Block will be performed unilaterally, under US guidance, before the surgical operation, when the patient is placed in the lateral decubitus position.
30 ml of 0.25% bupivacaine will be used in applications.
|
|
Active Comparator: Serratus Posterior Superior Intercostal Plane Block
The probe was placed on the spinae scapula in the sagittal plane to identify the second and third ribs.
The trapezius, rhomboid, serratus posterior superior muscle were visualized.
The needle was inserted just above the third rib deeply into the serratus posterior superior muscle.
Two mL isotonic was administrated for the correction.
Then, 30 mL of 0.25% bupivacaine was administrated between serratus posterior superior muscle and rib.
|
Serratus Posterior Superior Intercostal Plane Block will be performed unilaterally, under US guidance, before the surgical operation, when the patient is placed in the lateral decubitus position.
30 ml of 0.25% bupivacaine will be used in applications.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative analgesia
Time Frame: Postoperative day 1
|
Pain will be assessed with a visual analog scale (0-10 cm)
|
Postoperative day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative tramadol consumption
Time Frame: Perioperative day 1
|
The amount of tramadol consumed in the postoperative period will be recorded
|
Perioperative day 1
|
|
Patient satisfaction
Time Frame: Postoperative 24th hour
|
Satisfaction will be assessed with a 5 point Likert scale (0-4 whereas 0:definitely disagree; 1:slightly agree; 3: agree; 4: strongly agree)
|
Postoperative 24th hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 27, 2023
Primary Completion (Actual)
February 3, 2025
Study Completion (Actual)
February 17, 2025
Study Registration Dates
First Submitted
May 6, 2024
First Submitted That Met QC Criteria
May 6, 2024
First Posted (Actual)
May 9, 2024
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 11, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AEŞH-EK1-2023-824
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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