ESPB vs SPSIP for Postoperative Analgesia After CABG

N/ANot Yet RecruitingNCT07388745

Kutahya Health Sciences University64 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Coronary Arterial Disease Coronary Artery Bypass Grafting (CABG) Surgery

Interventions

Ultrasound-guided Erector Spinae Plane Block (ESPB)PROCEDURE

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).

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

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).

Eligibility

Sex: ALLMin age: 45 YearsMax age: 85 Years

Medical Language ↔ Plain English

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 * 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

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

Cumulative postoperative opioid consumption

Total opioid dose for analgesia converted to IV morphine equivalents.

Time frame: First 24 hours after surgery

Need for rescue analgesia

Proportion of participants requiring rescue analgesics in addition to the standardized protocol.

Time frame: Up to 48 hours after surgery

Quality of Recovery (QoR-15) score

"The Quality of Recovery-15 questionnaire (QoR-15) is a patient-reported measure consisting of 15 items. Each item is scored from 0 (unfavourable) to 10 (favourable), resulting in a total score ranging from 0 to 150. Higher total scores indicate better postoperative recovery.

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