Cardiac SurgerySPARENCT07780773
SPIP vs ESP Block in Cardiac Surgery
A study testing Bilateral Superficial Parasternal Intercostal Plane Block, Bilateral Erector Spinae Plane Block and morphine PCA in people with Cardiac Surgery and Chronic Postsurgical Pain, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiac Surgery, Chronic Postsurgical Pain, Postoperative Pain
- What is being tested?
- Bilateral Superficial Parasternal Intercostal Plane Block, Bilateral Erector Spinae Plane Block and morphine PCA
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 308 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2026to 1 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Refusal to participate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Burhan DOST contact
About this study
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
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.
Read the detailed description
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.
- Being tested
- Bilateral Superficial Parasternal Intercostal Plane Block, Bilateral Erector Spinae Plane Block, morphine PCA
- Keywords
- cardiac anesthesia, chronic post-surgical pain, nerve blocks, Erector Spinae Plane Block, Superficial Parasternal Intercostal Plane Block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral Superficial Parasternal Intercostal Plane BlockProcedure or surgery
Also called 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 BlockProcedure or surgery
Also called 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 PCADrug
Also called 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 group | Role | What they receive |
|---|---|---|
| Group SPIP | Active comparator | A bilateral SPIP Block(40 ml, %0.25 bupivacaine + 1:400,000 adrenaline, totally) + IV morphine patient-controlled analgesia (PCA) Receives: Procedure: Bilateral Superficial Parasternal Intercostal Plane Block; Drug: morphine PCA |
| Group ESP | Active comparator | A bilateral ESP Block(40 ml, %0.25 bupivacaine + 1:400,000 adrenaline, totally) + IV morphine patient-controlled analgesia (PCA) Receives: Procedure: Bilateral Erector Spinae Plane Block; Drug: morphine PCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From extubation to 24 hours after extubation
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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).
Measured: From extubation to 12 hours after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to one of two parallel intervention groups: bilateral SPIP block or bilateral ESP block. Randomization will be stratified by participating centre, and participants will remain in their assigned group throughout follow-up.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 308 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BURHAN DOST, Ondokuz Mayıs University
- Investigators
- Burhan DOST, Assoc.Prof, Study director, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07780773
- Sponsor's protocol ID
- SPARE2026
- Acronym
- SPARE
- Status last verified
- Oct 2026
- First submitted
- 16 Aug 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Dost B, Kaya C, Turunc E, Amaral S, Tulgar S, Gurkan Y, De Cassai A, Elsharkawy H. Thoracic wall fascial plane blocks: a narrative review for breast, thoracic, and cardiac surgery. J Anesth Analg Crit Care. 2025 Dec 16;6(1):9. doi: 10.1186/s44158-025-00328-w.
PubMed 41402872Joshi GP, Mariano ER, Elkassabany NM, Harbell M, Johnson RL, Li J, Napolitano L, Schwartz G, Suresh S, Wyatt-Thompson KE, Burns A, Agarkar M, Marbella A, Ramirez S, Sullivan N, Bloschichak A, Uhl S, Domino KB. 2026 American Society of Anesthesiologists Practice Guideline on Perioperative Pain Management Using Local and Regional Analgesia for Cardiothoracic Surgeries, Mastectomy, and Abdominal Surgeries. Anesthesiology. 2026 Jan 1;144(1):19-43. doi: 10.1097/ALN.0000000000005790. Epub 2025 Dec 9.
PubMed 41363869Grant MC, Crisafi C, Alvarez A, Arora RC, Brindle ME, Chatterjee S, Ender J, Fletcher N, Gregory AJ, Gunaydin S, Jahangiri M, Ljungqvist O, Lobdell KW, Morton V, Reddy VS, Salenger R, Sander M, Zarbock A, Engelman DT. Perioperative Care in Cardiac Surgery: A Joint Consensus Statement by the Enhanced Recovery After Surgery (ERAS) Cardiac Society, ERAS International Society, and The Society of Thoracic Surgeons (STS). Ann Thorac Surg. 2024 Apr;117(4):669-689. doi: 10.1016/j.athoracsur.2023.12.006. Epub 2024 Jan 28.
PubMed 38284956Demarquette A, Jeanneteau A, Blanchard-Daguet A, Fouquet O, Parot-Schinkel E, Lasocki S, Rineau E, Leger M. Impact of superficial and deep parasternal blocks on recovery after cardiac surgery with sternotomy: a randomised controlled trial. Br J Anaesth. 2025 Sep;135(3):764-771. doi: 10.1016/j.bja.2025.05.043. Epub 2025 Jul 9.
PubMed 40640047