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 2026-08-24.
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. Secondary outcomes include time-weighted average pain intensity at rest and during coughing over the first 24 hours after extubation, Quality of Recovery-15 scores at 24 hours and hospital discharge, and the incidence of chronic postsurgical pain at 3 months. Exploratory outcomes include rescue analgesic requirements, postoperative nausea and vomiting and other opioid-related adverse effects, time to extubation, intensive care unit and hospital length of stay, block failure, and block-related complications.
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.
Exclusion Criteria:
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 in the first 24 hours after surgery
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 at rest
Time-weighted average Numerical Rating Scale (NRS) pain intensity at rest over the first 24 hours after extubation, calculated from NRS scores obtained 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
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
Quality of Recovery-15 score at hospital discharge
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: At hospital discharge, up to postoperative day 30
Incidence of chronic postsurgical pain
Incidence of chronic postsurgical pain defined according to International Classification of Diseases 11th Revision (ICD-11) criteria as pain that develops or increases after surgery, persists for at least 3 months, is localized to the sternotomy area or a relevant referred region, and is not better explained by another cause.
Time frame: 3 months after surgery
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Ondokuz Mayıs University