- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06793436
Serratus Anterior Plan Block (SAP) and Pectoralis Blocks (PECS I-II) After Open Heart Surgery
May 13, 2026 updated by: Arzu Esen Tekeli, Yuzuncu Yil University
Serratus Anterior Plane and PECS II Blocks for Postoperative Analgesia After CABG: a Randomized Controlled Trial
It was aimed to examine the effects of anterior chest wall blocks (PECS and SAP) performed for postoperative analgesia on pain scores assessed using the Visual Analog Scale (VAS), opioid consumption, duration of mechanical ventilation, time to first mobilization, ICU length of stay, postoperative nausea and vomiting (PONV), and block-related complications in adult patients undergoing coronary artery bypass grafting (CABG).
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
This prospective randomized controlled trial evaluated the postoperative analgesic efficacy of ultrasound-guided serratus anterior plane (SAP) block and PECS II block in adult patients undergoing elective coronary artery bypass grafting (CABG).
Eligible patients were randomized into three groups: SAP block, PECS II block, and a control group receiving standard systemic analgesia without regional block.
The primary outcome was postoperative pain intensity assessed by Visual Analog Scale (VAS) scores at predefined post-extubation time points.
Secondary outcomes included total opioid consumption within the first 24 postoperative hours, postoperative nausea and vomiting (PONV), and block-related complications.
Exploratory recovery-related outcomes included mechanical ventilation duration, time to first mobilization, and ICU length of stay.
Recovery-related outcomes were analyzed descriptively and considered exploratory because ICU clinicians were not blinded and important perioperative confounders were not systematically collected.
Study Type
Interventional
Enrollment (Actual)
243
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
-
-
Tuşba
-
Van, Tuşba, Turkey (Türkiye), 65080
- Van Yuzuncu Yil University Faculty of Medicine Department of anesthesiology and reanimation
-
-
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
- Adult patients aged 20 years and older
- ASA physical status II-IV
- Scheduled for elective coronary artery bypass grafting (CABG)
- Provided written informed consent
Exclusion Criteria:
- Refusal to participate
- Pregnancy
- Presence of bleeding diathesis
- Severe hepatic or renal failure
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: SAP Block Group
Patients undergoing coronary artery bypass grafting received an ultrasound-guided serratus anterior plane (SAP) block with 30 mL of 0.25% bupivacaine administered to the fascial plane.
|
Ultrasound-guided serratus anterior plane (SAP) block performed with 30 mL of 0.25% bupivacaine.
|
|
Active Comparator: PECS II Block Group
Patients undergoing coronary artery bypass grafting received an ultrasound-guided PECS II block using a two-injection technique with a total of 30 mL of 0.25% bupivacaine.
|
Ultrasound-guided PECS II block performed using a two-injection technique with a total of 30 mL of 0.25% bupivacaine.
|
|
No Intervention: Group C
Patients receiving standard systemic analgesia without regional block.
All patients received intravenous paracetamol and rescue opioid analgesia as required according to institutional protocol.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative pain intensity assessed using the Visual Analog Scale (VAS)
Time Frame: 4, 8, 12, and 24 hours after extubation
|
Pain intensity will be assessed using the Visual Analog Scale (VAS).
The VAS is a 10-centimeter scale where 0 cm = "no pain" and 10 cm = "worst imaginable pain"; higher scores indicate worse pain intensity.
Assessments will be performed at 4, 8, 12, and 24 hours after extubation.
|
4, 8, 12, and 24 hours after extubation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative nausea and vomiting (PONV) and block-related complications
Time Frame: Within 24 hours after surgery
|
Postoperative adverse events including nausea, vomiting, and block-related complications will be recorded.
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Within 24 hours after surgery
|
|
Exploratory ICU length of stay
Time Frame: From ICU admission until ICU discharge, assessed up to 30 days
|
Length of stay in the intensive care unit measured in hours from ICU admission
|
From ICU admission until ICU discharge, assessed up to 30 days
|
|
Exploratory time to first mobilization
Time Frame: From ICU admission until first mobilization, assessed up to 7 days
|
Time from ICU admission to first mobilization measured in hours
|
From ICU admission until first mobilization, assessed up to 7 days
|
|
Exploratory mechanical ventilation duration
Time Frame: From ICU admission until successful extubation, assessed up to 7 days
|
Time from ICU admission to successful extubation
|
From ICU admission until successful extubation, assessed up to 7 days
|
|
Total opioid consumption within the first 24 postoperative hours
Time Frame: Cumulative opioid consumption assessed during the first 24 postoperative hours
|
Total postoperative opioid consumption will be recorded as cumulative tramadol and pethidine doses administered within the first 24 postoperative hours and converted to intravenous morphine equivalents.
|
Cumulative opioid consumption assessed during the first 24 postoperative hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: School of Mdicine Department of Anesthesiology and Reanimation, Yuzuncu Yil 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 5, 2022
Primary Completion (Actual)
December 5, 2023
Study Completion (Actual)
January 31, 2024
Study Registration Dates
First Submitted
May 17, 2023
First Submitted That Met QC Criteria
January 20, 2025
First Posted (Actual)
January 27, 2025
Study Record Updates
Last Update Posted (Actual)
May 18, 2026
Last Update Submitted That Met QC Criteria
May 13, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17/05/2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Participants' personal information will not be shared.
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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