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Clinical Trials/NCT07388745
NCT07388745
Not yet recruiting
Not Applicable

A Randomized Trial Comparing Erector Spinae Plane Block Versus Serratus Posterior Superior Intercostal Plane Block for Postoperative Analgesic Efficacy in Patients Undergoing Coronary Artery Bypass Graft Surgery

Kutahya Health Sciences University0 sites64 target enrollmentStarted: March 1, 2026Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Kutahya Health Sciences University
Enrollment
64
Primary Endpoint
Postoperative pain intensity

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
45 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • Emergency cases
  • 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

Arms & Interventions

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.

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

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.

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

Outcomes

Primary Outcomes

Postoperative pain intensity

Time Frame: 2, 4, 8, 16, 24, and 48 hours after surgery

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.

Secondary Outcomes

  • 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)

Investigators

Sponsor
Kutahya Health Sciences University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Merve Yaman

Assistant Professor

Kutahya Health Sciences University

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