- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07541040
Serratus vs ESP Block for Postoperative Pain in Unilateral Breast Surgery
Comparison of Serratus Posterior Superior Intercostal Plane Block and Erector Spinae Plane Block for Postoperative Analgesia in Unilateral Breast Surgery: A Prospective, Randomized, Assessor-Blinded Trial
This prospective, randomized, assessor-blinded trial compares serratus posterior superior intercostal plane block (SPSIPB) and erector spinae plane block (ESPB) for postoperative analgesia in unilateral breast surgery. 54 patients will be randomized to receive either SPSIPB or ESPB before general anesthesia.
The primary outcome is postoperative pain scores within the first 24 hours. The secondary outcome is opioid consumption.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This prospective, randomized, assessor-blinded, single-center clinical trial is designed to compare the effects of serratus posterior superior intercostal plane block (SPSIPB) and erector spinae plane block (ESPB) on postoperative analgesia in patients undergoing unilateral breast surgery. Eligible adult female patients will be randomly assigned in a 1:1 ratio to receive either SPSIPB or ESPB under ultrasound guidance prior to induction of general anesthesia.
All patients will receive standardized general anesthesia and postoperative multimodal analgesia. Postoperative pain will be assessed using the Numerical Rating Scale (NRS) at predefined time points within the first 24 hours, both at rest and during movement. The primary outcome is postoperative pain scores within 24 hours. The secondary outcome is total opioid consumption during the same period.
This study aims to determine whether SPSIPB provides comparable or superior analgesia compared to ESPB in unilateral breast surgery.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Engin Çetin, M.D.
- Phone Number: 90 5321206004
- Email: Doccetin52@gmail.com
Study Contact Backup
- Name: Engin Çetin, M.D
- Phone Number: 90 5321206004
- Email: Doccetin52@gmail.com
Study Locations
-
-
Kocaeli
-
İzmit, Kocaeli, Turkey (Türkiye), 41200
- University of Health Sciences Kocaeli City Hospital
-
Contact:
- Engin Çetin, M.D
- Phone Number: 90 532 120 60 04
- Email: Doccetin52@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Female patients aged 18-65 years
- ASA physical status I-III
- Body mass index (BMI) between 18 and 35 kg/m²
- Scheduled for elective unilateral breast surgery (mastectomy with or without sentinel lymph node biopsy)
- Ability to understand and provide written informed consent
Exclusion Criteria:
- Infection at the site of block application
- Known allergy to local anesthetics
- Coagulopathy or anticoagulant therapy
- Chronic opioid use
- Pregnancy
- Inability to communicate or cooperate
- Refusal to participate
- Failed block
- Requirement of additional intraoperative analgesia outside the study protocol
- Development of serious intraoperative complications
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: SPSIP Block
Participants will receive an ultrasound-guided serratus posterior superior intercostal plane block (SPSIPB) with 30 mL of 0.25% bupivacaine prior to induction of general anesthesia.
|
An ultrasound-guided interfascial plane block performed between the serratus posterior superior muscle and the underlying ribs prior to general anesthesia.
Other Names:
|
|
Active Comparator: ESPB Block
Participants will receive an ultrasound-guided erector spinae plane block (ESPB) with 30 mL of 0.25% bupivacaine prior to induction of general anesthesia.
|
An ultrasound-guided interfascial plane block performed between the serratus posterior superior muscle and the underlying ribs prior to general anesthesia.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Pain Scores (NRS)
Time Frame: T0: upon arrival at recovery (Aldrete ≥9), T1: 1 hour, T2: 4 hours, T3: 8 hours, T4: 12 hours, T5: 24 hours postoperatively
|
Postoperative pain intensity will be assessed using the Numerical Rating Scale (NRS; 0-10, where 0 indicates no pain and 10 indicates worst imaginable pain).
Pain scores will be evaluated both at rest and during movement (coughing)
|
T0: upon arrival at recovery (Aldrete ≥9), T1: 1 hour, T2: 4 hours, T3: 8 hours, T4: 12 hours, T5: 24 hours postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total Opioid Consumption
Time Frame: T0-T1: 0-1 hour, T1-T2: 1-4 hours, T2-T3: 4-8 hours, T3-T4: 8-12 hours, and T4-T5: 12-24 hours postoperatively
|
Total opioid consumption will be recorded during the first 24 hours postoperatively and expressed as intravenous tramadol consumption.
|
T0-T1: 0-1 hour, T1-T2: 1-4 hours, T2-T3: 4-8 hours, T3-T4: 8-12 hours, and T4-T5: 12-24 hours postoperatively
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Engin Çetin, M.D, Kocaeli City Hospital
Publications and helpful links
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KSH-ANREA-EC-05
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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