SPIP vs ESP Block in Cardiac Surgery

NCT07780773 | Not Yet Recruiting

• 1 other identifier: SPARE2026
• Study Type: interventional
• Target: 308
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiac Surgery; Chronic Postsurgical Pain; Postoperative Pain

Keywords

cardiac anesthesia; chronic post-surgical pain; nerve blocks; Erector Spinae Plane Block; Superficial Parasternal Intercostal Plane Block

Outcome Measures

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).

  From extubation to 24 hours after extubation

Secondary Outcomes (5)

• Time-weighted average pain intensity at rest

  From extubation to 24 hours after extubation

• Time-weighted average pain intensity during coughing

  From extubation to 24 hours after extubation

• Quality of Recovery-15 score at 24 hours

  24 hours after extubation

• Quality of Recovery-15 score at hospital discharge

  At hospital discharge, up to postoperative day 30

• Incidence of chronic postsurgical pain

  3 months after surgery

Study Arms (2)

Group SPIP

ACTIVE COMPARATOR

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

Group ESP

ACTIVE COMPARATOR

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

Interventions

Bilateral Superficial Parasternal Intercostal Plane Block PROCEDURE

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

Group SPIP

Bilateral Erector Spinae Plane Block PROCEDURE

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

Group ESP

morphine PCA DRUG

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

Group ESP; Group SPIP

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Burhan Dost

Samsun, 55270, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 41402872 BACKGROUND

• Joshi 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.

  PMID: 41363869 BACKGROUND

• Grant 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.

  PMID: 38284956 BACKGROUND

• Demarquette 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.

  PMID: 40640047 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Passive Cutaneous Anaphylaxis

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Skin Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques; Antigen-Antibody Reactions; Immune System Phenomena

Study Officials

• Burhan DOST, Assoc.Prof

  Ondokuz Mayıs University

  STUDY DIRECTOR

Central Study Contacts

Burhan DOST, Assoc.Prof

CONTACT

+903623121919; burhandost@hotmail.com

Burhan DOST

CONTACT

+903623121919

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This is an assessor-blinded trial. Participants and the anesthesiologists performing the regional block cannot be blinded because the SPIP and ESP blocks require different anatomical injection sites and may require different patient positioning. Postoperative outcome assessors and ICU staff performing structured study assessments will remain blinded to treatment allocation. The statistician will receive coded treatment groups and remain blinded until completion of the primary analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinating Investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 16, 2026
• First Posted: August 24, 2026
• Study Start (Estimated): September 10, 2026
• Primary Completion (Estimated): April 10, 2027
• Study Completion (Estimated): September 10, 2027
• Last Updated: August 24, 2026

Record last verified: 2026-08

Locations

TU (1)