Coronary Arterial DiseaseESP-SPSIP-CABGNCT07388745
ESPB vs SPSIP for Postoperative Analgesia After CABG
A study testing Ultrasound-guided Erector Spinae Plane Block (ESPB) and Ultrasound-guided Serratus Posterior Superior Intercostal Plane Block (SPSIPB) in people with Coronary Arterial Disease and Coronary Artery Bypass Grafting (CABG) Surgery, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
This prospective, randomized, active-controlled, double-blind, parallel-group study compares the postoperative analgesic efficacy and safety of ultrasound-guided bilateral Erector Spinae Plane Block (ESPB) versus bilateral Serratus Posterior Superior Intercostal Plane Block (SPSIPB) in adult patients (45-85 years, ASA… Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Coronary Arterial Disease, Coronary Artery Bypass Grafting (CABG) Surgery, Postoperative Pain Management
- What is being tested?
- Ultrasound-guided Erector Spinae Plane Block (ESPB) and Ultrasound-guided Serratus Posterior Superior Intercostal Plane Block (SPSIPB)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2026to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 45-85 years
- Scheduled for elective coronary artery bypass graft (CABG) surgery
- American Society of Anesthesiologists (ASA) I-II-III
- Patients who provide written informed consent and agree to participate in the study
Who cannot join
- Emergency cases
- ASA IV-V
- Known allergy to local anesthetics
- Coagulopathy (platelet count <100,000/mm³, INR >1.5, aPTT >1.5× normal)
- Infection at the block injection site
- Pregnancy
- Patients who do not provide written informed consent or decline to participate after being informed
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kütahya Health Sciences University Hospital
Kütahya, 43100
Merve Yaman, 05363794742, drmerveyaman@gmail.com
About this study
Official title: A Randomized Trial Comparing Erector Spinae Plane Block Versus Serratus Posterior Superior Intercostal Plane Block for Postoperative Analgesic Efficacy in Patients Undergoing Coronary Artery Bypass Graft Surgery
This prospective, randomized, active-controlled, double-blind, parallel-group study compares the postoperative analgesic efficacy and safety of ultrasound-guided bilateral Erector Spinae Plane Block (ESPB) versus bilateral Serratus Posterior Superior Intercostal Plane Block (SPSIPB) in adult patients (45-85 years, ASA I-III) undergoing elective coronary artery bypass graft surgery. The primary outcome is postoperative pain intensity assessed by Numeric Rating Scale (NRS) at 2, 4, 8, 16, 24, and 48 hours after surgery. Secondary outcomes include intraoperative fentanyl/remifentanil consumption, postoperative morphine consumption, patient-controlled analgesia (PCA) demand/delivery parameters (if PCA is used), need for rescue analgesics, extubation and mobilization times, peak inspiratory flow measured by incentive spirometry at predefined time points, ICU and hospital length of stay, recovery quality (QoR-15 at 0, 24, and 48 hours), mortality, and block-related adverse events.
- Conditions
- Coronary Arterial Disease, Coronary Artery Bypass Grafting (CABG) Surgery, Postoperative Pain Management
- Being tested
- Ultrasound-guided Erector Spinae Plane Block (ESPB), Ultrasound-guided Serratus Posterior Superior Intercostal Plane Block (SPSIPB)
- Keywords
- Coronary Artery Bypass Grafting, Erector Spinae Plane Block, Serratus Posterior Superior Intercostal Plane Block, Regional Anesthesia, Ultrasound-Guided Nerve Block, Postoperative Pain, Numeric Rating Scale
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided Erector Spinae Plane Block (ESPB)Procedure or surgery
Bilateral ultrasound-guided ESPB performed preoperatively under sedation at the T4-T5 transverse process level using 20 mL of 0.25% bupivacaine per side (total 40 mL).
Ultrasound-guided Serratus Posterior Superior Intercostal Plane Block (SPSIPB)Procedure or surgery
Bilateral ultrasound-guided SPSIPB performed preoperatively under sedation at the 2nd-3rd intercostal space using 20 mL of 0.25% bupivacaine per side (total 40 mL).
| Study group | Role | What they receive |
|---|---|---|
| Erector Spinae Plane Block (ESPB) | Active comparator | Ultrasound-guided bilateral Erector Spinae Plane Block will be performed preoperatively under sedation at the T4-T5 transverse process level. A total of 20 mL of 0.25% bupivacaine will be injected per side (total 40 mL). All participants will receive standardized general anesthesia for CABG and the same postoperative multimodal analgesia protocol. Receives: Procedure: Ultrasound-guided Erector Spinae Plane Block (ESPB) |
| Serratus Posterior Superior Intercostal Plane Block (SPSIPB) | Experimental | Ultrasound-guided bilateral Serratus Posterior Superior Intercostal Plane Block will be performed preoperatively under sedation at the 2nd-3rd intercostal space. A total of 20 mL of 0.25% bupivacaine will be injected per side (total 40 mL). All participants will receive standardized general anesthesia for CABG and the same postoperative multimodal analgesia protocol. Receives: Procedure: Ultrasound-guided Serratus Posterior Superior Intercostal Plane Block (SPSIPB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain intensity
Pain intensity will be assessed using the Numerical Rating Scale (NRS), ranging from 0 to 10, where 0 = no pain and 10 = worst imaginable pain. Higher scores indicate worse pain.
Measured: 2, 4, 8, 16, 24, and 48 hours after surgery
Secondary outcomes (3)
Cumulative postoperative opioid consumption
Total opioid dose for analgesia converted to IV morphine equivalents.
Measured: First 24 hours after surgery
Need for rescue analgesia
Proportion of participants requiring rescue analgesics in addition to the standardized protocol.
Measured: Up to 48 hours after surgery
Quality of Recovery (QoR-15) score
"The Quality of Recovery-15 questionnaire (QoR-15) is a patient-reported measure consisting of 15 items. Each item is scored from 0 (unfavourable) to 10 (favourable), resulting in a total score ranging from 0 to 150. Higher total scores indicate better postoperative recovery.
Measured: Baseline (preoperative), postoperative 24 hours, and 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start1 Mar 2026
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Arterial DiseaseStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Yaman, Kutahya Health Sciences University
- Investigators
- Merve Yaman, Assistant Professor, Principal investigator, Kütahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07388745
- Sponsor's protocol ID
- KSBÜ-KVC-CABG-ESPB-SPSIPB-2026
- Acronym
- ESP-SPSIP-CABG
- Status last verified
- Aug 2026
- First submitted
- 25 Jan 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Comparing Erector Spinae Plane Block Versus Serratus Posterior Superior Intercostal Plane Block for Postoperative Analgesic Efficacy in Patients Undergoing Coronary Artery Bypass Graft Surgery
- ClinicalTrials.gov ID
- NCT07388745
- Acronym / sponsor ID
- ESP-SPSIP-CABG / KSBÜ-KVC-CABG-ESPB-SPSIPB-2026
- Conditions
- Coronary Arterial Disease, Coronary Artery Bypass Grafting (CABG) Surgery, Postoperative Pain Management
- Keywords
- Coronary Artery Bypass Grafting, Erector Spinae Plane Block, Serratus Posterior Superior Intercostal Plane Block, Regional Anesthesia, Ultrasound-Guided Nerve Block, Postoperative Pain, Numeric Rating Scale
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 5 Feb 2026 (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, active-controlled, double-blind, parallel-group study compares the postoperative analgesic efficacy and safety of ultrasound-guided bilateral Erector Spinae Plane Block (ESPB) versus bilateral Serratus Posterior Superior Intercostal Plane Block (SPSIPB) in adult patients (45-85 years, ASA I-III) undergoing elective coronary artery bypass graft surgery. The primary outcome is postoperative pain intensity assessed by Numeric Rating Scale (NRS) at 2, 4, 8, 16, 24, and 48 hours after surgery. Secondary outcomes include intraoperative fentanyl/remifentanil consumption, postoperative morphine consumption, patient-controlled analgesia (PCA) demand/delivery parameters (if PCA is used), need for rescue analgesics, extubation and mobilization times, peak inspiratory flow measured by incentive spirometry at predefined time points, ICU and hospital length of stay, recovery quality (QoR-15 at 0, 24, and 48 hours), mortality, and block-related adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erector Spinae Plane Block (ESPB) | Active comparator | Procedure: Ultrasound-guided Erector Spinae Plane Block (ESPB)Ultrasound-guided bilateral Erector Spinae Plane Block will be performed preoperatively under sedation at the T4-T5 transverse process level. A total of 20 mL of 0.25% bupivacaine will be injected per side (total 40 mL). All participants will receive standardized general anesthesia for CABG and the same postoperative multimodal analgesia protocol. |
| Serratus Posterior Superior Intercostal Plane Block (SPSIPB) | Experimental | Procedure: Ultrasound-guided Serratus Posterior Superior Intercostal Plane Block (SPSIPB)Ultrasound-guided bilateral Serratus Posterior Superior Intercostal Plane Block will be performed preoperatively under sedation at the 2nd-3rd intercostal space. A total of 20 mL of 0.25% bupivacaine will be injected per side (total 40 mL). All participants will receive standardized general anesthesia for CABG and the same postoperative multimodal analgesia protocol. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 45-85 years
- Scheduled for elective coronary artery bypass graft (CABG) surgery
- American Society of Anesthesiologists (ASA) I-II-III
- Patients who provide written informed consent and agree to participate in the study
Key exclusion criteria (7 listed)
- Emergency cases
- ASA IV-V
- Known allergy to local anesthetics
- Coagulopathy (platelet count <100,000/mm³, INR >1.5, aPTT >1.5× normal)
- Infection at the block injection site
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 |
|---|---|---|
| Ultrasound-guided Erector Spinae Plane Block (ESPB)Bilateral ultrasound-guided ESPB performed preoperatively under sedation at the T4-T5 transverse process level using 20 mL of 0.25% bupivacaine per side (total 40 mL). | Procedure or surgery | Erector Spinae Plane Block (ESPB) |
| Ultrasound-guided Serratus Posterior Superior Intercostal Plane Block (SPSIPB)Bilateral ultrasound-guided SPSIPB performed preoperatively under sedation at the 2nd-3rd intercostal space using 20 mL of 0.25% bupivacaine per side (total 40 mL). | Procedure or surgery | Serratus Posterior Superior Intercostal Plane Block (SPSIPB) |
Primary outcome
Postoperative pain intensity
Time frame: 2, 4, 8, 16, 24, and 48 hours after surgery
Pain intensity will be assessed using the Numerical Rating Scale (NRS), ranging from 0 to 10, where 0 = no pain and 10 = worst imaginable pain. Higher scores indicate worse pain.
3 secondary outcomes
Cumulative postoperative opioid consumption
Time frame: First 24 hours after surgery
Need for rescue analgesia
Time frame: Up to 48 hours after surgery
Quality of Recovery (QoR-15) score
Time frame: Baseline (preoperative), postoperative 24 hours, and 48 hours after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Coronary Arterial Disease
Recruiting
A Prospective, Multicenter, Randomized Controlled Trial to Investigate the Value of Coronary CT Angiography in the Understanding and Management of Coronary Calcium (The Optimal Trial)
Cardiovascular Diseases, Myocardial Ischemia
RecruitingObservational study
Reliability of Multiple-Repetition-Maximum Tests in Patients With Cardiovascular Disease or Risk Factors
Heart Failure, Coronary Heart Disease (CHD)
Recruiting
Medipixel XA-Assisted PCI in Coronary Artery Disease
Percutaneous Coronary Intervention (PCI), Coronary Arterial Disease (CAD)
Active, not recruitingObservational study
Expanded Studies on the SCAPIS Stockholm Reexamination Cohort
Coronary Artery Disease, Arterial Stiffness, Blood Pressure
Recruiting
AGENT DCB STANCE: Safety and Effectiveness Study of AGENT Drug-Coated Balloon Compared to Standard of Care Percutaneous Coronary Intervention (PCI) Treatment for de Novo Coronary Lesions
Coronary Arterial Disease (CAD), de Novo Lesions in Native Coronary Arteries
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.
Merve Yaman, Assistant Professor principal investigator
Kütahya Health Sciences 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 Ultrasound-guided Erector Spinae Plane Block (ESPB) and Ultrasound-guided Serratus Posterior Superior Intercostal Plane Block (SPSIPB) in people with Coronary Arterial Disease and Coronary Artery Bypass Grafting (CABG) Surgery, run by Kutahya Health Sciences 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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 5 Aug 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Merve Yaman, Assistant Professor (+905363794742, merve.yaman@ksbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain intensity (time frame: 2, 4, 8, 16, 24, and 48 hours after surgery). 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 5 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.