ESPB vs SPSIP for Postoperative Analgesia After CABG

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-85
SponsorKutahya Health Sciences University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Emergency cases

ASA IV-V

Known allergy to local anesthetics

Coagulopathy (platelet count <100,000/mm³, INR >1.5, aPTT >1.5× normal)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ultrasound-guided Erector Spinae Plane Block (ESPB)

    Procedure/Surgery

    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/Surgery

    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).

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: Erector Spinae Plane Block (ESPB)Active comparator 1 intervention
Group B: Serratus Posterior Superior Intercostal Plane Block (SPSIPB)Experimental treatment 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Cumulative postoperative opioid consumption

Total opioid dose for analgesia converted to IV morphine equivalents.

Time frame
First 24 hours after surgery
2

Need for rescue analgesia

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

Time frame
Up to 48 hours after surgery
3

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

Other outcomes

Sponsors and contacts

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