This prospective, randomized, double-blind, parallel-group clinical trial within the Enhanced Recovery After Cardiac Surgery (ERACS) program compares postoperative analgesic effectiveness of bilateral erector spinae plane (ESP) block versus ESP combined with superficial parasternal intercostal plane (SPIP) block in adult patients undergoing elective cardiac surgery via median sternotomy.
Rationale: Effective multimodal, opioid-sparing analgesia is crucial in cardiac surgery to enhance recovery and reduce pulmonary and cognitive complications. Neuraxial techniques (e.g., epidural) carry increased hematoma risk under anticoagulation; hence, fascial plane blocks like ESP and SPIP are safer alternatives. Methodology: Randomized (ResearchRandomizer.org), 1:1 allocation, opaque sealed envelopes. ESP and SPIP performed under ultrasound guidance at standardized doses and locations. Blinding: Patients and postoperative evaluators are blinded; block-performing anesthesiologist unblinded but uninvolved in assessment. Follow-up: 0-72 hours after extubation with predefined time points for VAS, RASS, and Nu-DESC evaluations.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
42
A bilateral ultrasound-guided erector spinae plane block will be performed at the T4-T5 vertebral level after induction of general anesthesia. Using an 80 mm peripheral nerve block needle and an in-plane approach, 30 mL of 0.25% bupivacaine per side will be injected into the fascial plane deep to the erector spinae muscle. The spread of the local anesthetic will be visualized in real time in a craniocaudal direction. This technique provides multidermatomal somatic and visceral analgesia (approximately T2-T9).
After induction of general anesthesia, patients will receive: Bilateral ESP block with 20 mL of 0.25% bupivacaine per side, performed as described above at the T5 level, and Bilateral SPIP block performed at the 4th-5th intercostal spaces, approximately 2-3 cm lateral to the midline, using a linear ultrasound probe. For the SPIP block, after confirming needle placement with hydrodissection (1-3 mL saline) and negative aspiration, 10 mL of 0.25% bupivacaine per side will be injected between the pectoralis major and external intercostal muscles.
Ankara University Faculty of Medicine
Ankara, Turkey (Türkiye)
VAS (resting)
Average of VAS scores at 0, 1, 6, 12, 24, 48, and 72 hours after extubation (t=0). Lower scores indicate better analgesia. Pain was assessed using the 0-10 Visual Analog Scale (VAS). Pain severity was classified as follows: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-10 = severe pain. Rescue analgesia was administered when VAS score was \> 4.
Time frame: Up to 72 hours post-extubation
VAS (movement)
Mean VAS scores during movement at all time points
Time frame: 0-72 hours
Total rescue tramadol use (mg)
Cumulative IV tramadol dose
Time frame: 0-72 hours
Time to first rescue analgesic (min)
Time between extubation and first rescue tramadol
Time frame: 0-72 hours
Delirium incidence (Nu-DESC ≥ 2)
Nursing Delirium Screening Scale (Nu-DESC) score ≥ 2 Delirium was assessed using the Nursing Delirium Screening Scale (NU-DESC). NU-DESC consists of five items, each scored from 0 to 2 (total score: 0-10). A total NU-DESC score ≥ 2 was considered positive for delirium. Items: Disorientation Inappropriate behavior Inappropriate communication Illusions / hallucinations Psychomotor retardation
Time frame: 12, 24, 48, 72 hours
RASS score profile
Richmond Agitation-Sedation Scale distribution Sedation level was assessed using the Richmond Agitation-Sedation Scale (RASS). RASS scores were classified as: * 4 = combative, * 3 = very agitated, * 2 = agitated, * 1 = restless, 0 = alert and calm, * 1 = drowsy, * 2 = light sedation, * 3 = moderate sedation, * 4 = deep sedation, * 5 = unarousable.
Time frame: 0, 12, 24, 48, 72 hours
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