An interventional study of Bilateral Superficial Parasternal Intercostal Plane Block and Bilateral Erector Spinae Plane Block in Cardiac Surgery, Chronic Postsurgical Pain and Postoperative Pain, sponsored by Ondokuz Mayıs University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Ondokuz Mayıs University · Not applicable, Interventional, and Treatment
This multicentre, randomized, assessor-blinded, non-inferiority trial will compare the analgesic efficacy of bilateral superficial parasternal intercostal plane (SPIP) block with bilateral erector spinae plane (ESP) block in adults undergoing first-time on-pump cardiac surgery through median sternotomy. Participants will be randomly assigned in a 1:1 ratio to receive either SPIP or ESP block before induction of general anesthesia, in addition to standardized perioperative multimodal analgesia. The primary outcome is cumulative intravenous morphine milligram equivalent (IV-MME) consumption from extubation to 24 hours after extubation. The study will evaluate whether SPIP block is non-inferior to ESP block using a prespecified non-inferiority margin of 3 mg IV-MME.
This multicenter, parallel-group, randomized controlled non-inferiority trial will compare bilateral SPIP block with bilateral ESP block for postoperative analgesia in adults undergoing first-time on-pump cardiac surgery through median sternotomy.
Patients aged 18-80 years will be enrolled across tertiary cardiac surgery centres in Türkiye and randomly assigned in a 1:1 ratio, stratified by center, to receive either bilateral SPIP block or bilateral ESP block. Both interventions will be performed before induction of general anesthesia. Participants in the SPIP group will receive ultrasound-guided injection between 4th and 5th ribs, whereas participants in the ESP group will receive bilateral ultrasound-guided injection at the T5 transverse process.
Perioperative anesthesia, postoperative multimodal analgesia, and patient-controlled morphine analgesia will be standardised across participating centers. Postoperative outcome assessors will remain blinded to treatment allocation. Block success will be assessed using cold sensation testing before induction.
The primary outcome is cumulative opioid consumption from extubation to 24 hours after extubation, expressed as intravenous morphine milligram equivalents (IV-MME). The primary objective is to determine whether SPIP block is non-inferior to ESP block using a prespecified non-inferiority margin of 3 mg IV-MME.
The primary non-inferiority analysis will be performed in both the intention-to-treat and per-protocol populations. The between-group location shift in 24-hour IV-MME consumption will be estimated using the Hodges-Lehmann method with a two-sided 95% confidence interval. Non-inferiority will be concluded if the upper bound of the confidence interval for the SPIP minus ESP difference is less than 3 mg IV-MME.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's planned enrollment of 308 is above the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Ondokuz Mayıs University is the lead sponsor of 277 studies on the registry; 62 are open to participants now.
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The criteria were revised on the registry on Oct 21, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A bilateral SPIP Block(40 ml, %0.25 bupivacaine + 1:400,000 adrenaline, totally) + IV morphine patient-controlled analgesia (PCA)
Procedure: Bilateral Superficial Parasternal Intercostal Plane Block · Drug: morphine PCA
A bilateral ESP Block(40 ml, %0.25 bupivacaine + 1:400,000 adrenaline, totally) + IV morphine patient-controlled analgesia (PCA)
Procedure: Bilateral Erector Spinae Plane Block · Drug: morphine PCA
Participants in the SPIP group will receive a bilateral ultrasound-guided SPIP block before induction of general anesthesia and systemic heparinization. With the participant supine, a high-frequency linear transducer will be placed parasagittally adjacent to the sternum. The needle will be advanced in-plane between the pectoral is major and external intercostal muscles. After hydrodissection and negative aspiration, 20 mL of 0.25% bupivacaine with adrenaline 1:400,000 will be injected between the 4th and 5th ribs on each side (total 40 mL). In all participants, the surgeon will infiltrate 10 mL of 0.25% bupivacaine around the chest tube. The total bupivacaine dose will not exceed 3 mg/kg ideal body weight, with volume reduced proportionally if required.
Also known as: Superficial Parasternal Intercostal Plane Block
Participants in the ESP group will receive a bilateral ultrasound-guided erector spinae plane block before induction of general anesthesia and systemic heparinization. With the participant sitting or lateral, a high-frequency linear transducer will be placed parasagittally to identify the T5 transverse process and erector spinae muscle. The needle will be advanced in-plane deep to the erector spinae muscle. After hydrodissection and negative aspiration, 20 mL of 0.25% bupivacaine with adrenaline 1:400,000 will be injected on each side (total 40 mL). In all participants, the surgeon will infiltrate 10 mL of 0.25% bupivacaine around the chest tube. The total bupivacaine dose will not exceed 3 mg/kg ideal body weight, with volume reduced proportionally if required.
Also known as: Erector Spinae Plane Block
After extubation and recovery of adequate consciousness, intravenous patient-controlled analgesia (PCA) with morphine will be initiated. The PCA device will be programmed to deliver 1 mg of intravenous morphine per demand, with a 6-minute lockout interval, no background infusion, and a maximum dose of 20 mg over 4 hours. If pain persists at an NRS score of 4 or greater despite appropriate PCA use, additional intravenous morphine 1-3 mg may be administered as rescue analgesia. All PCA-delivered and rescue opioid doses will be recorded and converted to intravenous morphine milligram equivalents (IV-MME).
Also known as: PCA
Cumulative opioid consumption during the first 24 hours after extubation
Total opioid consumption from extubation to 24 hours after extubation, including morphine delivered by patient-controlled analgesia and any additional rescue opioids. All opioid doses will be converted to intravenous morphine milligram equivalents (IV-MME).
Time frame: From extubation to 24 hours after extubation
Time-weighted average pain intensity during coughing
Time-weighted average NRS pain intensity during coughing over the first 24 hours after extubation, calculated from assessments at 0, 6, 12, and 24 hours using the trapezoidal method. NRS ranges from 0 to 10, with higher scores indicating greater pain intensity.
Time frame: From extubation to 24 hours after extubation
Quality of Recovery-15 score at 24 hours
Quality of recovery assessed using the validated 15-item Quality of Recovery questionnaire (QoR-15). The total score ranges from 0 to 150, with higher scores indicating better postoperative recovery.
Time frame: 24 hours after extubation
Cumulative opioid consumption during the first 12 hours after extubation
Total opioid consumption from extubation to 12 hours after extubation, including morphine delivered by patient-controlled analgesia and any additional rescue opioids. All opioid doses will be converted to intravenous morphine milligram equivalents (IV-MME).
Time frame: From extubation to 12 hours after extubation
Time-weighted average pain intensity at rest
Time-weighted average NRS pain intensity at rest over the first 24 hours after extubation, calculated from assessments at 0, 6, 12, and 24 hours using the trapezoidal method. NRS ranges from 0 to 10, with higher scores indicating greater pain intensity.
Time frame: From extubation to 24 hours after extubation
Quality of Recovery-15 score at discharge
Quality of recovery assessed using the validated 15-item Quality of Recovery questionnaire (QoR-15).
Time frame: Postoperative 14 days on an average
Incidence of chronic postsurgical pain (CPSP) at postoperative 3rd month
CPSP, defined according to ICD-11 criteria.
Time frame: Postoperative 3rd month
Plan to share: Yes — De-identified individual participant data underlying the published results and the related data dictionary will be available upon reasonable request after publication, subject to participant consent, applicable data-protection requirements, and any necessary ethics approval.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Data will be available upon reasonable request beginning 12 months after publication of the primary trial results and for 5 years thereafter.
Access criteria: Requests should be directed to the corresponding author and include a scientifically sound research proposal specifying the intended analyses and the data required. The trial steering group will review requests. Access will be subject to approval of the proposal and a signed data-use agreement.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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