NCT07472296

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

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for not_applicable postoperative-pain

Timeline
5mo left

Started Nov 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress56%
Nov 2025Nov 2026

Study Start

First participant enrolled

November 1, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 16, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

March 16, 2026

Status Verified

February 1, 2026

Enrollment Period

11 months

First QC Date

March 5, 2026

Last Update Submit

March 13, 2026

Conditions

Keywords

Erector Spinae Plane BlockSerratus Anterior Plane BlockSuperficial Parasternal Intercostal Plane BlockOpioid ConsumptionMultimodal Analgesia

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 COMPARATOR

Participants in this group will receive a bilateral ultrasound-guided Erector Spinae Plane Block (ESPB) for postoperative analgesia.

Procedure: Erector spinae plane block (ESPB)

SPIPB and SAPB Group

ACTIVE COMPARATOR

Participants 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.

Procedure: Superficial Parasternal Intercostal Plane Block (SPIPB)Procedure: Serratus Anterior Plane Block (SAPB)

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.

Erector Spinae Plane Block Group

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

SPIPB and SAPB Group

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

SPIPB and SAPB Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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)

RECRUITING

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: 39583527BACKGROUND
  • Zou 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: 37273884BACKGROUND
  • Balan 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: 39470954BACKGROUND
  • Bousquet 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: 32843270BACKGROUND
  • Dost 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

Pain, PostoperativeAcute PainAgnosia

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

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.

Locations