Comparison of Erector Spinae Plane Block (ESPB) With the Combination of Superficial Parasternal Intercostal Plane Block (SPIPB) and Serratus Anterior Plane Block (SAPB) in the Management of Postoperative Sternotomy Pain in Patients Undergoing Cardiac Surgery Via Sternotomy
Sternotomi İle Kardiyak Cerrahi Planlanan Hastalarda Postoperatif Sternotomi Ağrısının Yönetiminde Erektör Spina Plan Blok (ESPB) Ile Yüzeyel Parasternal İnterkostal Plan Bloğu (SPIPB) ve Serratus Anterior Plan Bloğu (SAPB) Kombinasyonunun Karşılaştırılması
1 other identifier
interventional
50
1 country
1
Brief Summary
This study aims to compare the effectiveness of two regional anesthesia techniques in managing pain for participants undergoing cardiac surgery via sternotomy. The investigators will evaluate whether the Erector Spinae Plane Block (ESPB) or a combination of the Superficial Parasternal Intercostal Plane Block (SPIPB) and Serratus Anterior Plane Block (SAPB) provides better pain control and recovery outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable postoperative-pain
Started Nov 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2025
CompletedFirst Submitted
Initial submission to the registry
March 5, 2026
CompletedFirst Posted
Study publicly available on registry
March 16, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
March 16, 2026
February 1, 2026
11 months
March 5, 2026
March 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain Intensity (Visual Analog Scale Score)
Pain levels assessed using the Visual Analog Scale (0 = no pain, 10 = worst imaginable pain).
At 0, 1, 2, 4, 8, 12, 16 and 24 hours postoperatively.
Secondary Outcomes (4)
Extubation Time
From the end of surgery until the date of successful endotracheal tube removal, assessed up to 24 hours.
Total Postoperative Opioid Consumption
From the end of surgery up to 24 hours postoperatively.
Behavioral Pain Scale (BPS)
From ICU admission until extubation, assessed up to 24 hours.
Time to First Rescue Analgesic
From the end of surgery until the first dose of rescue analgesic, assessed up to 24 hours.
Study Arms (2)
Erector Spinae Plane Block Group
ACTIVE COMPARATORParticipants in this group will receive a bilateral ultrasound-guided Erector Spinae Plane Block (ESPB) for postoperative analgesia.
SPIPB and SAPB Group
ACTIVE COMPARATORParticipants in this group will receive a combination of bilateral ultrasound-guided Superficial Parasternal Intercostal Plane Block (SPIPB) and Serratus Anterior Plane Block (SAPB) for postoperative analgesia.
Interventions
Bilateral ultrasound-guided ESPB is performed at the T4 or T5 vertebral level. Following skin preparation and visualization of the transverse process and erector spinae muscle, a block needle is inserted. After confirming the needle tip position between the muscle and the transverse process, 0.5 mL/kg of 0.25% Bupivacaine is injected on each side.
Bilateral ultrasound-guided SPIPB is performed. 0.25% Bupivacaine is administered. This is part of a combined regional analgesia technique for sternotomy.
Bilateral ultrasound-guided SAPB is performed. 0.25% Bupivacaine is administered. This is part of a combined regional analgesia technique for the chest wall.
Eligibility Criteria
You may qualify if:
- Patients aged between 18 and 80 years.
- Patients classified as American Society of Anesthesiologists (ASA) physical status I, II, or III.
- Patients scheduled for elective cardiac surgery via median sternotomy.
- Patients who have provided written informed consent.
You may not qualify if:
- Pregnancy or suspected pregnancy.
- Body Mass Index (BMI) \> 35 kg/m².
- Known allergy or hypersensitivity to local anesthetics (e.g., bupivacaine).
- Suspected coagulopathy or bleeding disorders.
- Infection at the site of the regional block injection.
- Severe hepatic or renal failure.
- Severe neurological or psychiatric disorders.
- Emergency surgical procedures.
- Re-operation cases (Redo-surgery)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bursa Uludag University Hospital
Bursa, Nilüfer, 16235, Turkey (Türkiye)
Related Publications (5)
Yadav S, Raman R, Prabha R, Kaushal D, Yadav P, Kumar S. Randomized Controlled Trial of Ultrasound-Guided Parasternal Intercostal Nerve Block and Transversus Thoracis Muscle Plane Block for Postoperative Analgesia of Cardiac Surgical Patients. Cureus. 2024 Oct 23;16(10):e72174. doi: 10.7759/cureus.72174. eCollection 2024 Oct.
PMID: 39583527BACKGROUNDZou M, Ruan W, Liu J, Xu J. Preemptive parasternal intercostal nerve block for patients undergoing off-pump coronary artery bypass grafting: a double-blind, randomized, controlled trial. Front Cardiovasc Med. 2023 May 18;10:1188518. doi: 10.3389/fcvm.2023.1188518. eCollection 2023.
PMID: 37273884BACKGROUNDBalan C, Boros C, Morosanu B, Coman A, Stanculea I, Valeanu L, Sefan M, Pavel B, Ioan AM, Wong A, Bubenek-Turconi SI. Nociception level index-directed superficial parasternal intercostal plane block vs erector spinae plane block in open-heart surgery: a propensity matched non-inferiority clinical trial. J Clin Monit Comput. 2025 Feb;39(1):59-72. doi: 10.1007/s10877-024-01236-0. Epub 2024 Oct 29.
PMID: 39470954BACKGROUNDBousquet P, Labaste F, Gobin J, Marcheix B, Minville V. Bilateral Parasternal Block and Bilateral Erector Spinae Plane Block Reduce Opioid Consumption in During Cardiac Surgery. J Cardiothorac Vasc Anesth. 2021 Apr;35(4):1249-1250. doi: 10.1053/j.jvca.2020.07.021. Epub 2020 Jul 9. No abstract available.
PMID: 32843270BACKGROUNDDost B, Kaya C, Turunc E, Dokmeci H, Yucel SM, Karakaya D. Erector spinae plane block versus its combination with superficial parasternal intercostal plane block for postoperative pain after cardiac surgery: a prospective, randomized, double-blind study. BMC Anesthesiol. 2022 Sep 16;22(1):295. doi: 10.1186/s12871-022-01832-0.
PMID: 36114466BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Anesthesiology Resident
Study Record Dates
First Submitted
March 5, 2026
First Posted
March 16, 2026
Study Start
November 1, 2025
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
November 1, 2026
Last Updated
March 16, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share
The investigators do not plan to share individual participant data to protect patient privacy and comply with institutional data protection regulations.