NCT07287761

Brief Summary

Coronary Artery Bypass Grafting (CABG) is a common surgical procedure for ischemic heart disease, but it often leads to severe acute and chronic postoperative pain, which can delay recovery and reduce patient comfort. Effective pain management is crucial to prevent pulmonary complications and long hospital stays. Peripheral nerve blocks are increasingly used to reduce opioid consumption and improve patient satisfaction after major surgery. This prospective, observational study aims to compare the effectiveness and safety of two different regional anesthesia techniques, the Erector Spinae Plane Block (ESPB) and the Serratus Posterior Superior Intercostal Plane Block (SPSIPB), in managing postoperative pain in patients undergoing CABG via median sternotomy. Patients aged 18-80 years, classified as ASA II-III, who are scheduled for elective CABG will be included. The choice of block technique (ESPB or SPSIPB) will be determined by the operating anesthesiologist based on the visibility of anatomical structures (transverse processes) under ultrasound guidance. All patients will receive the same general anesthesia and be managed postoperatively with Intravenous Patient-Controlled Analgesia (PCA). The main goal is to determine which block provides optimal pain control, measured by the time to first rescue analgesia and pain scores (NRS) at various time points after extubation. Secondary outcomes include intraoperative opioid consumption, total PCA usage, extubation time, and the incidence of opioid-related side effects. The findings will help optimize pain protocols for cardiac surgery patients.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2025

Shorter than P25 for all trials

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 Start

First participant enrolled

November 1, 2025

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

November 25, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 17, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

December 17, 2025

Status Verified

December 1, 2025

Enrollment Period

4 months

First QC Date

November 25, 2025

Last Update Submit

December 3, 2025

Conditions

Keywords

Erector Spinae Plane Block (ESPB)Regional AnesthesiaPost-CABG PainPostoperative painCoronary Artery Bypass Graft SurgerySerratus Posterior Superior Intercostal Plane Block (SPSIPB)

Outcome Measures

Primary Outcomes (1)

  • Total Opioid Consumption in the Perioperative Period

    The cumulative dose of all opioids administered (Intraoperative Fentanyl and Post-Extubation Tramadol via PCA and rescue doses of Morphine) will be calculated in Morphine Equivalent Dose (mg).

    Up to 24 hours post-extubation

Study Arms (2)

ESPB Group

Erector Spinae Plane Block (ESPB) with Bupivacaine

SPSIPB Group

Serratus Posterior Superior Intercostal Plane Block (SPSIPB) with Bupivacaine

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of adult patients (18 to 80 years) classified as ASA Physical Status Class II or III, who are scheduled to undergo elective Coronary Artery Bypass Grafting (CABG) requiring median sternotomy at the University of Health Sciences Ankara Training and Research Hospital.

You may qualify if:

  • Patients scheduled for elective Coronary Artery Bypass Grafting (CABG) via median sternotomy.
  • Age between 18 and 80 years.
  • Classification of American Society of Anesthesiologists (ASA) Physical Status Class II or III.
  • Patients who provide written and verbal informed consent to participate in the study.

You may not qualify if:

  • Patients who do not provide consent.
  • Age older than 80 years or ASA Physical Status Class \> III.
  • Patients who do not understand the Numerical Rating Scale (NRS) or have communication difficulties.
  • Patients with a known history of coagulation disorders or bleeding disorders.
  • Patients with skin infection at the site of peripheral nerve block application.
  • Patients with Morbid Obesity (Body Mass Index BMI\>35 kg/m2).
  • Patients with chronic pain, opioid or substance dependence, or who use chronic analgesics.
  • Patients with known allergy to local anesthetics.
  • Patients with liver or kidney function disorders.
  • Patients with a history of previous median sternotomy operation.
  • Patients undergoing emergency surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Training and Research Hospital

Ankara, Altındag, 06230, Turkey (Türkiye)

RECRUITING

Related Publications (4)

  • Tulgar S, Ciftci B, Ahiskalioglu A, Bilal B, Sakul BU, Korkmaz AO, Bozkurt NN, De Cassai A, Torres AJ, Elsharkawy H, Alici HA. Serratus Posterior Superior Intercostal Plane Block: A Technical Report on the Description of a Novel Periparavertebral Block for Thoracic Pain. Cureus. 2023 Feb 3;15(2):e34582. doi: 10.7759/cureus.34582. eCollection 2023 Feb.

    PMID: 36883093BACKGROUND
  • Rothaug J, Zaslansky R, Schwenkglenks M, Komann M, Allvin R, Backstrom R, Brill S, Buchholz I, Engel C, Fletcher D, Fodor L, Funk P, Gerbershagen HJ, Gordon DB, Konrad C, Kopf A, Leykin Y, Pogatzki-Zahn E, Puig M, Rawal N, Taylor RS, Ullrich K, Volk T, Yahiaoui-Doktor M, Meissner W. Patients' perception of postoperative pain management: validation of the International Pain Outcomes (IPO) questionnaire. J Pain. 2013 Nov;14(11):1361-70. doi: 10.1016/j.jpain.2013.05.016. Epub 2013 Sep 7.

    PMID: 24021577BACKGROUND
  • Wang AH, Juan AH, Ko KD, Tsai PF, Zare H, Dell'Orso S, Sartorelli V. The Elongation Factor Spt6 Maintains ESC Pluripotency by Controlling Super-Enhancers and Counteracting Polycomb Proteins. Mol Cell. 2017 Oct 19;68(2):398-413.e6. doi: 10.1016/j.molcel.2017.09.016. Epub 2017 Oct 12.

    PMID: 29033324BACKGROUND
  • Mazzeffi M, Khelemsky Y. Poststernotomy pain: a clinical review. J Cardiothorac Vasc Anesth. 2011 Dec;25(6):1163-78. doi: 10.1053/j.jvca.2011.08.001. Epub 2011 Sep 29. No abstract available.

    PMID: 21955825BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

Abdullah KONAN, M.D

CONTACT

Suna AKIN TAKMAZ, M.D

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 25, 2025

First Posted

December 17, 2025

Study Start

November 1, 2025

Primary Completion

March 1, 2026

Study Completion

May 1, 2026

Last Updated

December 17, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

Individual participant data (IPD) that underlie the results reported in this article (such as anonymized patient-level data, study protocol, statistical analysis plan) will be shared. Data will be made available to researchers who provide a methodologically sound proposal for research and sign a data access agreement. Access will be provided after the article is published and for a period of 5 years following publication

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data will be made available beginning 6 months after publication of the main results in a peer-reviewed journal and will remain available for a period of 5 years after the publication date.
Access Criteria
Access will be granted to researchers who submit a methodologically sound proposal for research purposes. The requester must sign a Data Sharing Agreement guaranteeing the use of the data will be restricted to the proposed research and that the anonymity of participants will be protected. Data will be provided in an anonymized, de-identified format.

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