Coronary Arterial Disease, Coronary Artery Bypass Grafting (CABG) Surgery, Postoperative Pain Management
Conditions
Keywords
Coronary Artery Bypass Grafting, Erector Spinae Plane Block, Serratus Posterior Superior Intercostal Plane Block, Regional Anesthesia, Ultrasound-Guided Nerve Block, Postoperative Pain, Numeric Rating Scale
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.
Interventions
PROCEDUREUltrasound-guided Erector Spinae Plane Block (ESPB)
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).
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).
Sponsors
Kutahya Health Sciences University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 85 Years
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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain intensity | 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
| Measure | Time frame | Description |
|---|---|---|
| Cumulative postoperative opioid consumption | First 24 hours after surgery | Total opioid dose for analgesia converted to IV morphine equivalents. |
| Need for rescue analgesia | Up to 48 hours after surgery | Proportion of participants requiring rescue analgesics in addition to the standardized protocol. |
| Quality of Recovery (QoR-15) score | Baseline (preoperative), postoperative 24 hours, and 48 hours after surgery | "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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTMerve Yaman, Assistant Professor
PRINCIPAL_INVESTIGATORMerve Yaman, Assistant Professor
Kütahya Health Sciences University
Outcome results
None listed