Postoperative Pain ManagementESPB-SYSHEARTNCT07259057
Erector Spinae Plane Block and Postoperative Recovery After Open-Heart Surgery
A study testing Erector spinae plane block (ESPB) and Intravenous Opioid Analgesia in people with Postoperative Pain Management and Open-heart Surgery, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial summary
This prospective randomized controlled clinical trial evaluated the effects of bilateral erector spinae plane block (ESPB) on postoperative systemic functions in adult patients undergoing elective open-heart surgery via median sternotomy. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain Management, Open-heart Surgery, Median Sternotomy
- What is being tested?
- Erector spinae plane block (ESPB) and Intravenous Opioid Analgesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jan 2023to 20 Aug 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 75 years
- Scheduled for elective open-heart surgery via median sternotomy (CABG or valve surgery)
- ASA physical status II-III
- Provided written informed consent
- BMI < 35 kg/m²
Who cannot join
- Age <18 or >75 years
- Known coagulopathy or anticoagulation contraindicating regional block
- Infection or dermatological lesion at the injection site
- Allergy to local anesthetics
- Chronic use of opioids, anticonvulsants, antidepressants, or corticosteroids
- Significant psychiatric or cognitive disorder preventing cooperation
Show all 9Show fewer
- Severe arrhythmia or hemodynamic instability prior to surgery
- Local anesthetic toxicity risk factors or anatomic deformity preventing block placement
- Non-elective or emergency cardiac surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karadeniz Technical University Faculty of Medicine, Farabi Hospital
Trabzon, Trabzon, 61080
About this study
Official title: Effects of Erector Spinae Plane Block on Postoperative Systemic Functions in Patients Undergoing Open-Heart Surgery Via Sternotomy
This prospective randomized controlled clinical trial evaluated the effects of bilateral erector spinae plane block (ESPB) on postoperative systemic functions in adult patients undergoing elective open-heart surgery via median sternotomy. Sixty-six participants were randomized to receive either bilateral ultrasound-guided ESPB before anesthesia induction or standard intravenous opioid analgesia. Postoperative outcomes-including pain scores, rescue analgesic requirements, hemodynamic parameters, respiratory variables, and laboratory values-were monitored for forty-eight hours. The study was conducted to determine whether ESPB provides improved postoperative pain control and supports systemic recovery compared with intravenous opioid-based analgesia.
Read the detailed description
Open-heart surgery performed through median sternotomy is associated with significant postoperative pain, sympathetic activation, respiratory impairment, and delayed recovery. Conventional postoperative analgesia, primarily based on intravenous opioids, may provide adequate pain relief but is frequently limited by adverse effects such as sedation, nausea, respiratory depression, and hemodynamic fluctuations. Therefore, safer and more effective multimodal analgesia strategies are required for cardiac surgical patients.
The erector spinae plane block (ESPB) is a paraspinal interfascial block that allows the spread of local anesthetic to the dorsal and ventral rami, intercostal nerves, and paravertebral region, providing both somatic and visceral analgesia. ESPB has been increasingly used as an alternative to thoracic epidural analgesia, especially in patients undergoing cardiac surgery where neuraxial techniques may pose risks related to anticoagulation and sympathetic blockade.
This prospective randomized controlled clinical trial was designed to evaluate whether bilateral ultrasound-guided ESPB can improve postoperative systemic functions in patients undergoing elective open-heart surgery via sternotomy. A total of sixty-six adults classified as ASA II-III were randomized into two groups. The intervention group received bilateral ESPB at the T5 level using twenty milliliters of 0.25% bupivacaine per side prior to induction of general anesthesia, whereas the control group received standard intravenous opioid-based analgesia.
Postoperative outcomes were monitored for forty-eight hours and included pain scores measured by the Numeric Rating Scale (NRS), time to rescue analgesia, total analgesic consumption, hemodynamic parameters, respiratory measurements, and laboratory markers such as hemoglobin, creatinine, AST, and ALT. The primary objective was to determine whether ESPB provides superior postoperative pain control compared with intravenous opioid analgesia. Secondary objectives included assessing the effects of ESPB on hemodynamic stability, respiratory recovery, and systemic laboratory parameters.
The study was conducted after ethics committee approval, and written informed consent was obtained from all participants prior to enrollment.
- Conditions
- Postoperative Pain Management, Open-heart Surgery, Median Sternotomy, Erector Spinae Plane Block
- Being tested
- Erector spinae plane block (ESPB), Intravenous Opioid Analgesia
- Keywords
- Erector Spinae Plane Block, Regional Anesthesia, Open-Heart Surgery, Postoperative Pain, Postoperative Recovery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector spinae plane block (ESPB)Procedure or surgery
Bilateral ultrasound-guided erector spinae plane block performed at the T5 vertebral level before induction of general anesthesia.
A total of 20 mL of 0.25% bupivacaine was injected between the erector spinae muscle and the transverse process on each side using a high-frequency linear ultrasound probe and a 22-gauge needle.
Intravenous Opioid AnalgesiaDrug
Standard intravenous opioid-based analgesia administered without regional block. Fentanyl infusion (0.5 μg/kg/h) was started after induction and continued intraoperatively according to institutional protocol.
| Study group | Role | What they receive |
|---|---|---|
| Erector Spinae Plane Block (ESPB) | Experimental | Patients received bilateral ultrasound-guided erector spinae plane block at the T5 level before induction of general anesthesia. A total of 20 mL of 0.25% bupivacaine was injected on each side. Receives: Procedure: Erector spinae plane block (ESPB) |
| Intravenous Opioid Analgesia (Control) | Active comparator | Standard intravenous opioid-based analgesia administered without regional block.
A fentanyl infusion (0.5 μg/kg/h) was initiated immediately after induction of general anesthesia and continued intraoperatively per institutional protocol. Receives: Drug: Intravenous Opioid Analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity (NRS Score)
Pain intensity will be assessed using the Numeric Rating Scale (NRS; 0 = no pain, 10 = worst imaginable pain) at standardized postoperative time points.
Measured: First 12 hours after extubation (measured at 1, 6, and 12 hours)
Secondary outcomes (9)
Time to First Rescue Analgesic Requirement
Time in hours from extubation to first administration of rescue analgesia (tramadol or diclofenac).
Measured: Within 48 hours post-extubation
Total Rescue Analgesic Consumption
Total amount of rescue analgesics administered (mg of tramadol and diclofenac) during the first 48 postoperative hours.
Measured: 48 hours post-extrubation
Heart Rate (beats per minute)
Heart rate (HR) values recorded at predefined postoperative intervals.
Measured: First 24 postoperative hours
Mobilization Time
Time from ICU admission to first successful mobilization (sitting or standing with assistance).
Measured: Up to postoperative day 3
Length of Hospital Stay
Total duration of postoperative hospitalization, measured in days.
Measured: From completion of surgery until hospital discharge, up to 14 days.
Postoperative Hemoglobin Change
Difference between preoperative and postoperative hemoglobin levels (g/dL).
Measured: 24 hours after surgery
Serum Creatinine Level (mg/dL)
Serum creatinine concentration will be measured as an indicator of postoperative renal function. Values are reported in milligrams per deciliter (mg/dL). Higher values indicate worse renal function.
Measured: Preoperative baseline and postoperative 24 hours (up to 24 hours after surgery).
Mean Arterial Pressure (mmHg)
Mean arterial pressure (MAP) values recorded at predefined postoperative intervals.
Measured: First 24 postoperative hours
Urine Output (mL/kg/hour)
Urine output will be measured as an indicator of renal perfusion and early postoperative renal function. Values are reported in milliliters per kilogram per hour (mL/kg/h). Higher values indicate better renal function.
Measured: First 24 hours after surgery (up to 24 hours postoperative).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start30 Jan 2023
- Primary completion30 Jun 2024
- Study completion20 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative Pain ManagementStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study used a parallel-group randomized controlled design in which participants were allocated in a 1:1 ratio to receive either bilateral erector spinae plane block (ESPB) before anesthesia induction or standard intravenous opioid-based analgesia. Both groups were followed concurrently throughout the perioperative and postoperative periods for outcome assessment.
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali AKDOĞAN, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07259057
- Sponsor's protocol ID
- KTU-ESPB-2022-247
- Acronym
- ESPB-SYSHEART
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sarica F, Erturk E, Kutanis D, Akdogan A, Senel AC. Comparison of Thoracic Epidural Analgesia and Traditional Intravenous Analgesia With Respect to Postoperative Respiratory Effects in Cardiac Surgery. J Cardiothorac Vasc Anesth. 2021 Jun;35(6):1800-1805. doi: 10.1053/j.jvca.2020.09.110. Epub 2020 Sep 20.
PubMed 33059978Oostvogels L, Weibel S, Meissner M, Kranke P, Meyer-Friessem CH, Pogatzki-Zahn E, Schnabel A. Erector spinae plane block for postoperative pain. Cochrane Database Syst Rev. 2024 Feb 12;2(2):CD013763. doi: 10.1002/14651858.CD013763.pub3.
PubMed 38345071Shan XS, Liao DW, Guo J, Xia ZY, Lv X, Shen J, Tong JH, Wei FJ, Li XS, Qu XF, Wang XB, Wang YB, Ou SS, Yang YF, Meng L, Liu H, Peng K, Ji FH. Effect of liposomal bupivacaine for preoperative erector spinae plane block on postoperative pain following video-assisted thoracoscopic lung resection: a multicenter, randomized, double-blind, clinical trial. Int J Surg. 2026 Feb 1;112(2):3690-3700. doi: 10.1097/JS9.0000000000003956. Epub 2025 Nov 11.
PubMed 41217370
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Erector Spinae Plane Block on Postoperative Systemic Functions in Patients Undergoing Open-Heart Surgery Via Sternotomy
- ClinicalTrials.gov ID
- NCT07259057
- Acronym / sponsor ID
- ESPB-SYSHEART / KTU-ESPB-2022-247
- Conditions
- Postoperative Pain Management, Open-heart Surgery, Median Sternotomy, Erector Spinae Plane Block
- Keywords
- Erector Spinae Plane Block, Regional Anesthesia, Open-Heart Surgery, Postoperative Pain, Postoperative Recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 20 Aug 2024 (actual)
- First posted
- 2 Dec 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 controlled clinical trial evaluated the effects of bilateral erector spinae plane block (ESPB) on postoperative systemic functions in adult patients undergoing elective open-heart surgery via median sternotomy. Sixty-six participants were randomized to receive either bilateral ultrasound-guided ESPB before anesthesia induction or standard intravenous opioid analgesia. Postoperative outcomes-including pain scores, rescue analgesic requirements, hemodynamic parameters, respiratory variables, and laboratory values-were monitored for forty-eight hours. The study was conducted to determine whether ESPB provides improved postoperative pain control and supports systemic recovery compared with intravenous opioid-based analgesia.
Detailed description
Open-heart surgery performed through median sternotomy is associated with significant postoperative pain, sympathetic activation, respiratory impairment, and delayed recovery. Conventional postoperative analgesia, primarily based on intravenous opioids, may provide adequate pain relief but is frequently limited by adverse effects such as sedation, nausea, respiratory depression, and hemodynamic fluctuations. Therefore, safer and more effective multimodal analgesia strategies are required for cardiac surgical patients.
The erector spinae plane block (ESPB) is a paraspinal interfascial block that allows the spread of local anesthetic to the dorsal and ventral rami, intercostal nerves, and paravertebral region, providing both somatic and visceral analgesia. ESPB has been increasingly used as an alternative to thoracic epidural analgesia, especially in patients undergoing cardiac surgery where neuraxial techniques may pose risks related to anticoagulation and sympathetic blockade.
This prospective randomized controlled clinical trial was designed to evaluate whether bilateral ultrasound-guided ESPB can improve postoperative systemic functions in patients undergoing elective open-heart surgery via sternotomy. A total of sixty-six adults classified as ASA II-III were randomized into two groups. The intervention group received bilateral ESPB at the T5 level using twenty milliliters of 0.25% bupivacaine per side prior to induction of general anesthesia, whereas the control group received standard intravenous opioid-based analgesia.
Postoperative outcomes were monitored for forty-eight hours and included pain scores measured by the Numeric Rating Scale (NRS), time to rescue analgesia, total analgesic consumption, hemodynamic parameters, respiratory measurements, and laboratory markers such as hemoglobin, creatinine, AST, and ALT. The primary objective was to determine whether ESPB provides superior postoperative pain control compared with intravenous opioid analgesia. Secondary objectives included assessing the effects of ESPB on hemodynamic stability, respiratory recovery, and systemic laboratory parameters.
The study was conducted after ethics committee approval, and written informed consent was obtained from all participants prior to enrollment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study used a parallel-group randomized controlled design in which participants were allocated in a 1:1 ratio to receive either bilateral erector spinae plane block (ESPB) before anesthesia induction or standard intravenous opioid-based analgesia. Both groups were followed concurrently throughout the perioperative and postoperative periods for outcome assessment.
| Arm | Type | Receives |
|---|---|---|
| Erector Spinae Plane Block (ESPB) | Experimental | Procedure: Erector spinae plane block (ESPB)Patients received bilateral ultrasound-guided erector spinae plane block at the T5 level before induction of general anesthesia. A total of 20 mL of 0.25% bupivacaine was injected on each side. |
| Intravenous Opioid Analgesia (Control) | Active comparator | Drug: Intravenous Opioid AnalgesiaStandard intravenous opioid-based analgesia administered without regional block. A fentanyl infusion (0.5 μg/kg/h) was initiated immediately after induction of general anesthesia and continued intraoperatively per institutional protocol. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 to 75 years
- Scheduled for elective open-heart surgery via median sternotomy (CABG or valve surgery)
- ASA physical status II-III
- Provided written informed consent
- BMI < 35 kg/m²
Key exclusion criteria (9 listed)
- Age <18 or >75 years
- Known coagulopathy or anticoagulation contraindicating regional block
- Infection or dermatological lesion at the injection site
- Allergy to local anesthetics
- Chronic use of opioids, anticonvulsants, antidepressants, or corticosteroids
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 |
|---|---|---|
| Erector spinae plane block (ESPB)Bilateral ultrasound-guided erector spinae plane block performed at the T5 vertebral level before induction of general anesthesia. A total of 20 mL of 0.25% bupivacaine was injected between the erector spinae muscle and the transverse process on each side using a high-frequency linear ultrasound probe and a 22-gauge needle. | Procedure or surgery | Erector Spinae Plane Block (ESPB) |
| Intravenous Opioid AnalgesiaStandard intravenous opioid-based analgesia administered without regional block. Fentanyl infusion (0.5 μg/kg/h) was started after induction and continued intraoperatively according to institutional protocol. | Drug | Intravenous Opioid Analgesia (Control) |
Primary outcome
Postoperative Pain Intensity (NRS Score)
Time frame: First 12 hours after extubation (measured at 1, 6, and 12 hours)
Pain intensity will be assessed using the Numeric Rating Scale (NRS; 0 = no pain, 10 = worst imaginable pain) at standardized postoperative time points.
9 secondary outcomes
Time to First Rescue Analgesic Requirement
Time frame: Within 48 hours post-extubation
Total Rescue Analgesic Consumption
Time frame: 48 hours post-extrubation
Heart Rate (beats per minute)
Time frame: First 24 postoperative hours
Mobilization Time
Time frame: Up to postoperative day 3
Length of Hospital Stay
Time frame: From completion of surgery until hospital discharge, up to 14 days.
Postoperative Hemoglobin Change
Time frame: 24 hours after surgery
Serum Creatinine Level (mg/dL)
Time frame: Preoperative baseline and postoperative 24 hours (up to 24 hours after surgery).
Mean Arterial Pressure (mmHg)
Time frame: First 24 postoperative hours
Urine Output (mL/kg/hour)
Time frame: First 24 hours after surgery (up to 24 hours postoperative).
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 2 Dec 2025.
- Results publication: PubMed 33059978Sarica F, Erturk E, Kutanis D, Akdogan A, Senel AC. Comparison of Thoracic Epidural Analgesia and Traditional Intravenous Analgesia With Respect to Postoperative Respiratory Effects in Cardiac Surgery. J Cardiothorac Vasc Anesth. 2021 Jun;35(6):1800-1805. doi: 10.1053/j.jvca.2020.09.110. Epub 2020 Sep 20.
- Results publication: PubMed 38345071Oostvogels L, Weibel S, Meissner M, Kranke P, Meyer-Friessem CH, Pogatzki-Zahn E, Schnabel A. Erector spinae plane block for postoperative pain. Cochrane Database Syst Rev. 2024 Feb 12;2(2):CD013763. doi: 10.1002/14651858.CD013763.pub3.
- Results publication: PubMed 41217370Shan XS, Liao DW, Guo J, Xia ZY, Lv X, Shen J, Tong JH, Wei FJ, Li XS, Qu XF, Wang XB, Wang YB, Ou SS, Yang YF, Meng L, Liu H, Peng K, Ji FH. Effect of liposomal bupivacaine for preoperative erector spinae plane block on postoperative pain following video-assisted thoracoscopic lung resection: a multicenter, randomized, double-blind, clinical trial. Int J Surg. 2026 Feb 1;112(2):3690-3700. doi: 10.1097/JS9.0000000000003956. Epub 2025 Nov 11.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector spinae plane block (ESPB) and Intravenous Opioid Analgesia in people with Postoperative Pain Management and Open-heart Surgery, run by Karadeniz Technical 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 5 inclusion and 9 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 2 Dec 2025. 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?
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 (NRS Score) (time frame: First 12 hours after extubation (measured at 1, 6, and 12 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07259057, which also lists 3 linked publications.
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 2 Dec 2025.