SPIP vs ESP Block in Cardiac Surgery

Sponsor
Ondokuz Mayıs University
Study ID
NCT07780773
Status
Not Yet Recruiting

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Conditions

  • Cardiac Surgery
  • Chronic Postsurgical Pain
  • Postoperative Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

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.
  • 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.
  • 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).

Study Details

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.

Key Dates

First listed
Aug 24, 2026
Start date
Sep 10, 2026
Status verified
Aug 2026
Primary completion
Apr 10, 2027
Completion
Sep 10, 2027

Study Design

Enrollment
308 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Group SPIP
    A bilateral SPIP Block(40 ml, %0.25 bupivacaine + 1:400,000 adrenaline, totally) + IV morphine patient-controlled analgesia (PCA)
  • Active Comparator: Group ESP
    A bilateral ESP Block(40 ml, %0.25 bupivacaine + 1:400,000 adrenaline, totally) + IV morphine patient-controlled analgesia (PCA)

Primary Outcome Measure

Cumulative opioid consumption in the first 24 hours after surgery [ Time Frame: From extubation to 24 hours after extubation ]

Central Contacts

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