NCT07388745

Brief Summary

This prospective, randomized, active-controlled, double-blind, parallel-group study compares the postoperative analgesic efficacy and safety of ultrasound-guided bilateral Erector Spinae Plane Block (ESPB) versus bilateral Serratus Posterior Superior Intercostal Plane Block (SPSIPB) in adult patients (45-85 years, ASA I-III) undergoing elective coronary artery bypass graft surgery. The primary outcome is postoperative pain intensity assessed by Numeric Rating Scale (NRS) at 2, 4, 8, 16, 24, and 48 hours after surgery. Secondary outcomes include intraoperative fentanyl/remifentanil consumption, postoperative morphine consumption, patient-controlled analgesia (PCA) demand/delivery parameters (if PCA is used), need for rescue analgesics, extubation and mobilization times, peak inspiratory flow measured by incentive spirometry at predefined time points, ICU and hospital length of stay, recovery quality (QoR-15 at 0, 24, and 48 hours), mortality, and block-related adverse events.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started Mar 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

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 Progress37%
Mar 2026Aug 2026

First Submitted

Initial submission to the registry

January 25, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 5, 2026

Completed
24 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

February 5, 2026

Status Verified

February 1, 2026

Enrollment Period

4 months

First QC Date

January 25, 2026

Last Update Submit

February 4, 2026

Conditions

Keywords

Coronary Artery Bypass GraftingErector Spinae Plane BlockSerratus Posterior Superior Intercostal Plane BlockRegional AnesthesiaUltrasound-Guided Nerve BlockPostoperative PainNumeric Rating Scale

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain intensity

    Pain intensity will be assessed using the Numerical Rating Scale (NRS), ranging from 0 to 10, where 0 = no pain and 10 = worst imaginable pain. Higher scores indicate worse pain.

    2, 4, 8, 16, 24, and 48 hours after surgery

Secondary Outcomes (3)

  • Cumulative postoperative opioid consumption

    First 24 hours after surgery

  • Need for rescue analgesia

    Up to 48 hours after surgery

  • Quality of Recovery (QoR-15) score

    Baseline (preoperative), postoperative 24 hours, and 48 hours after surgery

Study Arms (2)

Erector Spinae Plane Block (ESPB)

ACTIVE COMPARATOR

Ultrasound-guided bilateral Erector Spinae Plane Block will be performed preoperatively under sedation at the T4-T5 transverse process level. A total of 20 mL of 0.25% bupivacaine will be injected per side (total 40 mL). All participants will receive standardized general anesthesia for CABG and the same postoperative multimodal analgesia protocol.

Procedure: Ultrasound-guided Erector Spinae Plane Block (ESPB)

Serratus Posterior Superior Intercostal Plane Block (SPSIPB)

EXPERIMENTAL

Ultrasound-guided bilateral Serratus Posterior Superior Intercostal Plane Block will be performed preoperatively under sedation at the 2nd-3rd intercostal space. A total of 20 mL of 0.25% bupivacaine will be injected per side (total 40 mL). All participants will receive standardized general anesthesia for CABG and the same postoperative multimodal analgesia protocol.

Procedure: Ultrasound-guided Serratus Posterior Superior Intercostal Plane Block (SPSIPB)

Interventions

Bilateral ultrasound-guided ESPB performed preoperatively under sedation at the T4-T5 transverse process level using 20 mL of 0.25% bupivacaine per side (total 40 mL).

Erector Spinae Plane Block (ESPB)

Bilateral ultrasound-guided SPSIPB performed preoperatively under sedation at the 2nd-3rd intercostal space using 20 mL of 0.25% bupivacaine per side (total 40 mL).

Serratus Posterior Superior Intercostal Plane Block (SPSIPB)

Eligibility Criteria

Age45 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 45-85 years
  • Scheduled for elective coronary artery bypass graft (CABG) surgery
  • American Society of Anesthesiologists (ASA) I-II-III
  • Patients who provide written informed consent and agree to participate in the study

You may not qualify if:

  • Emergency cases
  • ASA IV-V
  • Known allergy to local anesthetics
  • Coagulopathy (platelet count \<100,000/mm³, INR \>1.5, aPTT \>1.5× normal)
  • Infection at the block injection site
  • Pregnancy
  • Patients who do not provide written informed consent or decline to participate after being informed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Merve Yaman, Assistant Professor

    Kütahya Health Sciences University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Merve Yaman, Assistant Professor

CONTACT

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
Assistant Professor

Study Record Dates

First Submitted

January 25, 2026

First Posted

February 5, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

February 5, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share