SPIP vs ESP Block in Cardiac Surgery
Not yet recruitingNot applicableNCT07780773
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Comparative Analgesic Efficacy of Superficial Parasternal Intercostal Plane Block Versus Erector Spinae Plane Block After Cardiac Surgery: a Multicenter Randomized Non-inferiority Trial
- Conditions
- Cardiac Surgery
- Chronic Postsurgical Pain
- Postoperative Pain
- Interventions
- Procedure: Bilateral Superficial Parasternal Intercostal Plane Block
- Procedure: Bilateral Erector Spinae Plane Block
- Drug: morphine PCA
- Sponsor
- Ondokuz Mayıs University
- Start date
- 2026-09-10
- Primary completion
- 2027-04-10
- Sex
- All
- Age range
- from 18 Years to 80 Years
- Results posted
- No results posted in this snapshot
- Countries
- Turkey (Türkiye)
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07780773