Kütahya Health Sciences University Hospital
Kütahya, 43100, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07388745
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.
Interested in participating?
Request Info45 year–85 year
All sexes
Interventional
Not applicable
Kütahya, 43100, Turkey (Türkiye)
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
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.
Time frame: First 24 hours after surgery
Total opioid dose for analgesia converted to IV morphine equivalents.
Time frame: Up to 48 hours after surgery
Proportion of participants requiring rescue analgesics in addition to the standardized protocol.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Kutahya Health Sciences University
Other
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
Acronym: ESP-SPSIP-CABG
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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