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NCT Number: NCT07472296

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bursa Uludag University Hospital

Bursa, Nilüfer, 16235, Turkey (Türkiye)

Location status: Recruiting

Location contact

Ali Haydar Colak, Medical Doctor

CONTACT

[email protected]

+905065603517 ext. +902242953131

Elif Basagan Mogol, Professor of Anesthesiology

PRINCIPAL_INVESTIGATOR

Onur Alp, Medical Doctor

CONTACT

[email protected]

+905399565511 ext. +902242953131

About this study

The investigators aim to compare the effects of the erector spinae plane block (ESPB) versus the combination of superficial parasternal intercostal plane block (SPIPB) and serratus anterior plane block (SAPB) in the management of postoperative sternotomy pain among participants scheduled for cardiac surgery via sternotomy.

Study design and methods: A total of 50 participants (aged 18-80, ASA I-III) scheduled for sternotomy will be randomly assigned to one of two groups:

ESPB Group: Participants receive the Erector Spinae Plane Block. SPIPB + SAPB Group: Participants receive a combination of both blocks. Prior to the induction of general anesthesia, participants are randomized into two groups: the ESPB group and the SPIPB + SAPB group. Nerve blocks are performed in both groups. Visual Analog Scale (VAS) scores at rest and during coughing, intraoperative opioid consumption, postoperative behavioral pain scores, extubation times, and time to the first rescue analgesic requirement are evaluated.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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)

Treatment and study plan

Erector spinae plane block (ESPB)

Procedure

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.

Superficial Parasternal Intercostal Plane Block (SPIPB)

Procedure

Bilateral ultrasound-guided SPIPB is performed. 0.25% Bupivacaine is administered. This is part of a combined regional analgesia technique for sternotomy.

Serratus Anterior Plane Block (SAPB)

Procedure

Bilateral ultrasound-guided SAPB is performed. 0.25% Bupivacaine is administered. This is part of a combined regional analgesia technique for the chest wall.

Primary outcomes

  1. Pain Intensity (Visual Analog Scale Score)

    Time frame: At 0, 1, 2, 4, 8, 12, 16 and 24 hours postoperatively.

    Pain levels assessed using the Visual Analog Scale (0 = no pain, 10 = worst imaginable pain).

Secondary outcomes

  1. Extubation Time

    Time frame: From the end of surgery until the date of successful endotracheal tube removal, assessed up to 24 hours.

    The duration from the end of the surgical procedure until the patient is successfully extubated.

  2. Total Postoperative Opioid Consumption

    Time frame: From the end of surgery up to 24 hours postoperatively.

    Total amount of opioid (e.g., morphine or fentanyl) administered to the patient in the first 24 hours.

  3. Behavioral Pain Scale (BPS)

    Time frame: From ICU admission until extubation, assessed up to 24 hours.

    Pain assessment based on facial expression, upper limb movement, and compliance with ventilation.

  4. Time to First Rescue Analgesic

    Time frame: From the end of surgery until the first dose of rescue analgesic, assessed up to 24 hours.

    The time elapsed from the end of surgery until the patient first requires additional pain medication.

Sponsors and collaborators

Lead sponsor

Uludag University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 16, 2026
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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