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Clinical Trials in South Korea / NCT07262944
Recruiting Not applicable

EOI Block in Otoplasty With Rib Cartilage Graft

NCT07262944 · tracked via the Priya Life Science South Korea tracker
Sponsor
Seoul National University Hospital
Phase
Not applicable
Started
2026-12-01
Last updated
2025-12-04

Condition(s) studied

Postoperative Pain, Acute

Investigational drug(s) / intervention(s)

Ultrasound-guided External Oblique Intercostal (EOI) Fascial Plane BlockStandard postoperative pain management (no EOI block)

Ultrasound-guided External Oblique Intercostal (EOI) Fascial Plane Block: 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.

Standard postoperative pain management (no EOI block): 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.

Study summary

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.

Eligibility

Sex
ALL
Min age
13 Years
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria: * \- Pediatric patients aged 13 to 18 years undergoing otoplasty with rib cartilage graft under general anesthesia at Seoul National University Children's Hospital * Written informed consent obtained from parent or legal guardian, and assent from the patient Exclusion Criteria: * Unstable vital signs before surgery (heart rate \<50 or \>150 beats/min, systolic blood pressure \<80 mmHg or \>160 mmHg) * Known hypersensitivity to ropivacaine or other amide-type local anesthetics * Massive bleeding or shock * Local infection at the injection site * Sepsis * History of allergy to opioid medications * Severe renal dysfunction (creatinine \>3.0 mg/dL) * Severe hepatic dysfunction (AST or ALT \>120 U/L) * Any condition that, in the investigator's opinion, makes the subject unsuitable for study participation

Primary outcome measure(s)

  • Total opioid consumption within 24 hours after surgery — 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).

Trial sites (1)

FacilityCityRegionStatus
Seoul National University Hospital Seoul South Korea Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07262944 on ClinicalTrials.gov ↗ ← All trials in South Korea