SPIP vs ESP Block in Cardiac Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorOndokuz Mayıs University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
written informed consent
age 18 to 80 years
American Society of Anesthesiologists (ASA) physical status II-IV
Scheduled for first-time on-pump cardiac surgery through a median sternotomy, including coronary artery bypass grafting, valve repair or replacement, or another open cardiac procedure requiring sternotomy
Disqualifiers
Emergency surgery.
Previous median sternotomy.
Minimally invasive cardiac surgery without median sternotomy.
Known allergy or hypersensitivity to bupivacaine, morphine, paracetamol, ondansetron or another protocol medication.
Trial design
Design model
Parallel
Treatments tested in this trial
Bilateral Superficial Parasternal Intercostal Plane Block
Procedure/SurgeryParticipants 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.
Bilateral Erector Spinae Plane Block
Procedure/SurgeryParticipants 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.
morphine PCA
DrugAfter 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).
Treatment groups
308 Participants
are divided into 2 treatment groupsGroup A: Group SPIPActive comparator 2 interventions
Group B: Group ESPActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
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 extubationSecondary outcomes
1
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 extubation2
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 extubation3
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 extubation4
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 30Sponsors and contacts
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Source ClinicalTrials.gov
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