Postoperative PainNCT06793436
Serratus Anterior Plane and PECS II Blocks After Coronary Artery Bypass Grafting
A study testing Bilateral Serratus Anterior Plane Block and Bilateral PECS II Block in people with Postoperative Pain and Coronary Artery Bypass Grafting, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
This prospective randomized placebo-controlled trial was designed to evaluate the effects of ultrasound-guided bilateral pectoralis (PECS II) and serratus anterior plane (SAP) blocks on postoperative recovery in adult patients undergoing elective coronary artery bypass grafting (CABG). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Postoperative Pain, Coronary Artery Bypass Grafting
- What is being tested?
- Bilateral Serratus Anterior Plane Block and Bilateral PECS II Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 243 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Dec 2022to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 20 years and older ASA physical status II-IV Scheduled for elective coronary artery bypass grafting (CABG) via median sternotomy Extubated in the intensive care unit after surgery Provided written informed consent
Who cannot join
- Refusal to participate or inability to provide informed consent Pregnancy Known allergy or contraindication to bupivacaine or other amide local anesthetics Coagulopathy or ongoing anticoagulation precluding regional anesthesia Local infection at the planned injection site Severe hepatic or renal failure Pre-existing chronic opioid use or chronic pain requiring opioid treatment Pre-existing neurological disorders affecting pain assessment Requirement for emergency surgery or concomitant cardiac procedures other than isolated CABG Reoperation for postoperative bleeding before outcome assessment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Van Yuzuncu Yil University Faculty of Medicine Department of anesthesiology and reanimation
Van, Tuşba, 65080
About this study
Official title: Postoperative Bilateral Serratus Anterior Plane Versus PECS II Block in Intubated Patients Undergoing Elective Coronary Artery Bypass Grafting: A Prospective, Randomized, Placebo-Controlled Trial
This prospective randomized placebo-controlled trial was designed to evaluate the effects of ultrasound-guided bilateral pectoralis (PECS II) and serratus anterior plane (SAP) blocks on postoperative recovery in adult patients undergoing elective coronary artery bypass grafting (CABG). Patients were randomized to receive bilateral PECS II block, bilateral SAP block, or bilateral sham fascial plane injections in addition to standardized systemic analgesia. The study evaluated postoperative pain intensity using the Visual Analog Scale (VAS), opioid consumption, postoperative nausea and vomiting (PONV), block-related complications, duration of mechanical ventilation, time to first mobilization, and intensive care unit (ICU) length of stay.
Read the detailed description
This prospective, randomized, placebo-controlled trial evaluated the postoperative analgesic efficacy of ultrasound-guided bilateral serratus anterior plane (SAP) block and bilateral PECS II block in adult patients undergoing elective coronary artery bypass grafting (CABG). Participants were randomly assigned to one of three groups: bilateral SAP block, bilateral PECS II block, or bilateral sham fascial plane injections (placebo comparator). All participants received the same standardized postoperative systemic analgesic regimen.
To preserve allocation concealment and blinding, an investigator not involved in patient management prepared identical coded syringes according to the randomization sequence. The physician performing the ultrasound-guided procedures was unaware of syringe contents. All participants underwent bilateral injections at both the PECS II and SAP fascial planes; depending on group allocation, each fascial plane received either 0.25% bupivacaine or 0.9% saline. Postoperative outcome assessment was performed by investigators blinded to treatment allocation.
The primary outcome was postoperative pain intensity measured using the Visual Analog Scale (VAS) at predefined time points after extubation. Secondary outcomes included cumulative opioid consumption during the first 24 postoperative hours, postoperative nausea and vomiting (PONV), and block-related complications. Additional recovery-related outcomes included duration of mechanical ventilation, time to first mobilization, and intensive care unit (ICU) length of stay. These recovery outcomes were analyzed as exploratory endpoints because important perioperative factors influencing recovery were not systematically collected.
- Being tested
- Bilateral Serratus Anterior Plane Block, Bilateral PECS II Block, Sham Fascial Plane Procedure
- Keywords
- Serratus Anterior Plane Block, PECS II Block, Regional Anesthesia, Opioid-Sparing, Coronary Artery Bypass Grafting, post operative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral Serratus Anterior Plane BlockProcedure or surgery
Ultrasound-guided bilateral serratus anterior plane (SAP) block performed using 20 mL of 0.25% bupivacaine on each side after ICU admission while patients remained intubated following elective coronary artery bypass grafting.
Bilateral PECS II BlockProcedure or surgery
Ultrasound-guided bilateral PECS II block was performed using the standard two-injection technique after ICU admission while patients remained intubated following elective coronary artery bypass grafting. On each side, a total of 20 mL of 0.25% bupivacaine was injected between the pectoralis major and minor muscles and between the pectoralis minor and serratus anterior muscles.
Sham Fascial Plane ProcedureProcedure or surgery
Ultrasound-guided bilateral sham fascial plane procedure was performed after ICU admission while patients remained intubated following elective coronary artery bypass grafting. On each side, 20 mL of 0.9% saline was injected at both the PECS II and serratus anterior plane injection sites using identical coded syringes to maintain study blinding.
| Study group | Role | What they receive |
|---|---|---|
| Bilateral SAP Block | Experimental | Participants undergoing elective coronary artery bypass grafting received an ultrasound-guided bilateral serratus anterior plane (SAP) block using 20 mL of 0.25% bupivacaine on each side. To maintain study blinding, ultrasound-guided placebo injections consisting of 20 mL of 0.9% saline were also administered bilaterally at the PECS II injection sites using identical coded syringes. Receives: Procedure: Bilateral Serratus Anterior Plane Block |
| Bilateral PECS II Block | Active comparator | Participants undergoing elective coronary artery bypass grafting received an ultrasound-guided bilateral PECS II block using 20 mL of 0.25% bupivacaine on each side. To maintain study blinding, ultrasound-guided placebo injections consisting of 20 mL of 0.9% saline were also administered bilaterally at the serratus anterior plane injection sites using identical coded syringes. Receives: Procedure: Bilateral PECS II Block |
| Sham Block | Placebo comparator | Participants undergoing elective coronary artery bypass grafting received ultrasound-guided bilateral placebo injections consisting of 20 mL of 0.9% saline on each side at both the PECS II and serratus anterior plane injection sites using identical coded syringes to maintain study blinding. All participants received the same standardized postoperative systemic analgesic regimen. Receives: Procedure: Sham Fascial Plane Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain intensity assessed using the Visual Analog Scale (VAS)
Postoperative pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity. Assessments will be performed at 4, 8, 12, and 24 hours after extubation.
Measured: 4, 8, 12, and 24 hours after extubation
Secondary outcomes (6)
Postoperative nausea and vomiting (PONV)
The occurrence of postoperative nausea and/or vomiting will be recorded during the first 24 hours after surgery.
Measured: Within 24 hours after surgery
Block-related complications
Block-related complications, including local anesthetic systemic toxicity, hematoma, infection, pneumothorax, vascular puncture, nerve injury, or other procedure-related adverse events, will be recorded.
Measured: During hospitalization
Length of intensive care unit (ICU) stay
Length of stay in the intensive care unit (ICU), measured in hours from ICU admission to ICU discharge.
Measured: From ICU admission to ICU discharge (assessed up to 30 days).
Time to first mobilization
Time from ICU admission to first mobilization, measured in hours.
Measured: From ICU admission to first mobilization (assessed up to 7 days).
Duration of mechanical ventilation
Duration of mechanical ventilation, measured as the time from ICU admission to successful extubation, in hours.
Measured: From ICU admission to successful extubation (assessed up to 7 days).
Total tramadol and pethidine consumption within the first 24 postoperative hours
Cumulative intravenous tramadol and pethidine doses administered during the first 24 postoperative hours will be recorded and reported separately in milligrams.
Measured: Within the first 24 postoperative hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start5 Dec 2022
- Primary completion5 Dec 2023
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, placebo-controlled, parallel-group, double-dummy trial comparing postoperative bilateral serratus anterior plane block, PECS II block, and sham intervention in mechanically ventilated patients undergoing elective coronary artery bypass grafting.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 243 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arzu Esen Tekeli, Yuzuncu Yil University
- Investigators
- School of Mdicine Department of Anesthesiology and Reanimation, Study chair, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06793436
- Sponsor's protocol ID
- YYU-2022-03
- Status last verified
- Sep 2026
- First submitted
- 17 May 2023
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data (IPD) will be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Bilateral Serratus Anterior Plane Versus PECS II Block in Intubated Patients Undergoing Elective Coronary Artery Bypass Grafting: A Prospective, Randomized, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT06793436
- Acronym / sponsor ID
- YYU-2022-03
- Keywords
- Serratus Anterior Plane Block, PECS II Block, Regional Anesthesia, Opioid-Sparing, Coronary Artery Bypass Grafting, post operative pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 5 Dec 2022 (actual)
- Primary completion
- 5 Dec 2023 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 27 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective randomized placebo-controlled trial was designed to evaluate the effects of ultrasound-guided bilateral pectoralis (PECS II) and serratus anterior plane (SAP) blocks on postoperative recovery in adult patients undergoing elective coronary artery bypass grafting (CABG). Patients were randomized to receive bilateral PECS II block, bilateral SAP block, or bilateral sham fascial plane injections in addition to standardized systemic analgesia. The study evaluated postoperative pain intensity using the Visual Analog Scale (VAS), opioid consumption, postoperative nausea and vomiting (PONV), block-related complications, duration of mechanical ventilation, time to first mobilization, and intensive care unit (ICU) length of stay.
Detailed description
This prospective, randomized, placebo-controlled trial evaluated the postoperative analgesic efficacy of ultrasound-guided bilateral serratus anterior plane (SAP) block and bilateral PECS II block in adult patients undergoing elective coronary artery bypass grafting (CABG). Participants were randomly assigned to one of three groups: bilateral SAP block, bilateral PECS II block, or bilateral sham fascial plane injections (placebo comparator). All participants received the same standardized postoperative systemic analgesic regimen.
To preserve allocation concealment and blinding, an investigator not involved in patient management prepared identical coded syringes according to the randomization sequence. The physician performing the ultrasound-guided procedures was unaware of syringe contents. All participants underwent bilateral injections at both the PECS II and SAP fascial planes; depending on group allocation, each fascial plane received either 0.25% bupivacaine or 0.9% saline. Postoperative outcome assessment was performed by investigators blinded to treatment allocation.
The primary outcome was postoperative pain intensity measured using the Visual Analog Scale (VAS) at predefined time points after extubation. Secondary outcomes included cumulative opioid consumption during the first 24 postoperative hours, postoperative nausea and vomiting (PONV), and block-related complications. Additional recovery-related outcomes included duration of mechanical ventilation, time to first mobilization, and intensive care unit (ICU) length of stay. These recovery outcomes were analyzed as exploratory endpoints because important perioperative factors influencing recovery were not systematically collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Prospective, randomized, placebo-controlled, parallel-group, double-dummy trial comparing postoperative bilateral serratus anterior plane block, PECS II block, and sham intervention in mechanically ventilated patients undergoing elective coronary artery bypass grafting.
| Arm | Type | Receives |
|---|---|---|
| Bilateral SAP Block | Experimental | Procedure: Bilateral Serratus Anterior Plane BlockParticipants undergoing elective coronary artery bypass grafting received an ultrasound-guided bilateral serratus anterior plane (SAP) block using 20 mL of 0.25% bupivacaine on each side. To maintain study blinding, ultrasound-guided placebo injections consisting of 20 mL of 0.9% saline were also administered bilaterally at the PECS II injection sites using identical coded syringes. |
| Bilateral PECS II Block | Active comparator | Procedure: Bilateral PECS II BlockParticipants undergoing elective coronary artery bypass grafting received an ultrasound-guided bilateral PECS II block using 20 mL of 0.25% bupivacaine on each side. To maintain study blinding, ultrasound-guided placebo injections consisting of 20 mL of 0.9% saline were also administered bilaterally at the serratus anterior plane injection sites using identical coded syringes. |
| Sham Block | Placebo comparator | Procedure: Sham Fascial Plane ProcedureParticipants undergoing elective coronary artery bypass grafting received ultrasound-guided bilateral placebo injections consisting of 20 mL of 0.9% saline on each side at both the PECS II and serratus anterior plane injection sites using identical coded syringes to maintain study blinding. All participants received the same standardized postoperative systemic analgesic regimen. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults aged 20 years and older ASA physical status II-IV Scheduled for elective coronary artery bypass grafting (CABG) via median sternotomy Extubated in the intensive care unit after surgery Provided written informed consent
Key exclusion criteria (1 listed)
- Refusal to participate or inability to provide informed consent Pregnancy Known allergy or contraindication to bupivacaine or other amide local anesthetics Coagulopathy or ongoing anticoagulation precluding regional anesthesia Local infection at the planned injection site Severe hepatic or renal failure Pre-existing chronic opioid use or chronic pain requiring opioid treatment Pre-existing neurological disorders affecting pain assessment Requirement for emergency surgery or concomitant cardiac procedures other than isolated CABG Reoperation for postoperative bleeding before outcome assessment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bilateral Serratus Anterior Plane BlockUltrasound-guided bilateral serratus anterior plane (SAP) block performed using 20 mL of 0.25% bupivacaine on each side after ICU admission while patients remained intubated following elective coronary artery bypass grafting. | Procedure or surgery | Bilateral SAP Block |
| Bilateral PECS II BlockUltrasound-guided bilateral PECS II block was performed using the standard two-injection technique after ICU admission while patients remained intubated following elective coronary artery bypass grafting. On each side, a total of 20 mL of 0.25% bupivacaine was injected between the pectoralis major and minor muscles and between the pectoralis minor and serratus anterior muscles. | Procedure or surgery | Bilateral PECS II Block |
| Sham Fascial Plane ProcedureUltrasound-guided bilateral sham fascial plane procedure was performed after ICU admission while patients remained intubated following elective coronary artery bypass grafting. On each side, 20 mL of 0.9% saline was injected at both the PECS II and serratus anterior plane injection sites using identical coded syringes to maintain study blinding. | Procedure or surgery | Sham Block |
Primary outcome
Postoperative pain intensity assessed using the Visual Analog Scale (VAS)
Time frame: 4, 8, 12, and 24 hours after extubation
Postoperative pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity. Assessments will be performed at 4, 8, 12, and 24 hours after extubation.
6 secondary outcomes
Postoperative nausea and vomiting (PONV)
Time frame: Within 24 hours after surgery
Block-related complications
Time frame: During hospitalization
Length of intensive care unit (ICU) stay
Time frame: From ICU admission to ICU discharge (assessed up to 30 days).
Time to first mobilization
Time frame: From ICU admission to first mobilization (assessed up to 7 days).
Duration of mechanical ventilation
Time frame: From ICU admission to successful extubation (assessed up to 7 days).
Total tramadol and pethidine consumption within the first 24 postoperative hours
Time frame: Within the first 24 postoperative hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No. No individual participant data (IPD) will be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
School of Mdicine Department of Anesthesiology and Reanimation study chair
Yuzuncu Yil University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral Serratus Anterior Plane Block and Bilateral PECS II Block in people with Postoperative Pain and Coronary Artery Bypass Grafting, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain intensity assessed using the Visual Analog Scale (VAS) (time frame: 4, 8, 12, and 24 hours after extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.