This randomized controlled trial aims to evaluate the effect of ultrasound-guided external oblique intercostal (EOI) fascial plane block on postoperative pain control and recovery in pediatric patients undergoing otoplasty with rib cartilage graft under general anesthesia. Participants aged 13 to 18 years will be randomly assigned to receive either EOI block with 0.2% ropivacaine or no block. Primary outcome is total opioid consumption within 24 hours after surgery. Secondary outcomes include NRS pain scores, incentive spirometry performance, incidence of atelectasis, and patient satisfaction.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
60
Under general anesthesia, a linear ultrasound probe (6-13 MHz) is placed transversely at the 8th-9th intercostal space along the anterior axillary line. A 22-gauge, 50-80 mm needle is advanced in-plane into the fascial plane between the external oblique and intercostal muscles. After confirming correct needle placement, 0.2% ropivacaine 0.5 mL/kg (maximum 30 mL) is injected. The procedure is performed at the end of otoplasty with rib cartilage graft to provide postoperative analgesia.
Participants will not receive the EOI block. All other perioperative management, including general anesthesia and postoperative intravenous patient-controlled analgesia (IV-PCA) with fentanyl, will be identical to the experimental group.
Seoul National University Hospital
Seoul, South Korea
RECRUITINGTotal opioid consumption within 24 hours after surgery
Total amount of opioid analgesic (fentanyl) administered via intravenous patient-controlled analgesia (IV-PCA) and additional rescue doses within 24 hours postoperatively. The total dose will be normalized to body weight (µg/kg).
Time frame: Within 24 hours after surgery
Pain intensity at rest
Pain intensity at rest assessed using the Numerical Rating Scale (NRS, 0-10; higher scores = worse pain)
Time frame: Up to 24 hours after surgery
Pain intensity during deep breathing
Pain intensity during deep breathing assessed using the Numerical Rating Scale (NRS, 0-10; higher scores = worse pain)
Time frame: Up to 24 hours after surgery
Total non-opioid analgesic consumption
Total consumption of non-opioid analgesics (e.g., acetaminophen, NSAIDs) within 24 hours after surgery
Time frame: Up to 24 hours after surgery
Overall satisfaction with postoperative pain control
Overall patient satisfaction with postoperative pain control assessed using a 0-100 satisfaction scale (higher scores = better satisfaction)
Time frame: Up to 24 hours after surgery
Incidence of analgesic-related adverse events
Incidence of adverse events related to analgesics (nausea, vomiting, pruritus, dizziness, constipation, dry mouth, etc.)
Time frame: Up to 24 hours after surgery
Incentive spirometry performance
Performance on incentive spirometry measured as the number of balls lifted at 30 minutes after PACU admission (Unit of Measure: number of balls (count))
Time frame: Within 30 minutes after PACU arrival
Incidence of postoperative atelectasis
Presence or absence of atelectasis evaluated on chest X-ray approximately 24 hours postoperatively
Time frame: Up to 24 hours after surgery
Distribution of sensory block
Dermatomal distribution of cold sensation loss assessed by alcohol swab test in the PACU by a blinded assessor, evaluated in standardized zones (midline, midclavicular, anterior/mid-axillary lines).
Time frame: At 30 minutes after PACU admission
Sleep quality
Quality of sleep on the night of operation assessed on a 0-100 scale (0 = very poor, 100 = excellent).
Time frame: Night of surgery
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