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Clinical Trials in Turkey / NCT07780773
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SPIP vs ESP Block in Cardiac Surgery

NCT07780773 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2026-09-10
Last updated
2026-08-24

Condition(s) studied

Cardiac SurgeryChronic Postsurgical PainPostoperative Pain

Investigational drug(s) / intervention(s)

Bilateral Superficial Parasternal Intercostal Plane BlockBilateral Erector Spinae Plane Blockmorphine PCA

Bilateral Superficial Parasternal Intercostal Plane Block: 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.

Bilateral Erector Spinae 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.

morphine PCA: 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).

Study summary

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

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * 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 * Ability to understand postoperative pain and recovery assessments and to use an intravenous patient-controlled analgesia device. Exclusion Criteria: * 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. * Chronic opioid use, defined as continuous opioid treatment for at least 30 days at a daily oral morphine equivalent dose of 15 mg or more. * Alcohol or substance use disorder that, in the investigator's judgment, may affect adherence or outcome assessment. * Clinically significant hepatic dysfunction, defined as alanine aminotransferase or aspartate aminotransferase greater than twice the upper limit of normal. * Clinically significant renal dysfunction, defined as serum creatinine greater than twice the upper limit of normal. * Coagulation disorder or antithrombotic treatment that precludes safe block performance according to current institutional guidance. * Infection at a planned needle insertion site. * Severe psychiatric illness, cognitive impairment or communication difficulty preventing valid postoperative assessment. * Pregnancy or breastfeeding. * Body mass index greater than 40 kg/m². * Prolonged postoperative mechanical ventilation, defined as failure to achieve extubation within 8 hours after surgery. * Refusal to participate.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Burhan Dost Samsun Turkey (Türkiye)

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07780773 on ClinicalTrials.gov ↗ ← All trials in Turkey