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Recruiting NCT07262944

EOI Block in Otoplasty With Rib Cartilage Graft

No phase Interventional Postoperative Pain, Acute

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ultrasound-guided External Oblique Intercostal (EOI) Fascial Plane Block, Standard postoperative pain management (no EOI block).
Who it may be relevant to
Registry conditions: Postoperative Pain, Acute. Basic parameters: 13 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Effect of Ultrasound-Guided External Oblique Intercostal Fascial Plane Block in Pediatric Patients Undergoing Otoplasty With Rib Cartilage Graft

Overview

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.

Interventions

  • Procedure 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.
  • Procedure 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.

Primary outcome measures

  • Total opioid consumption within 24 hours after surgery [Time frame: Within 24 hours after surgery]
Secondary outcome measures (9)
  • Pain intensity at rest [Time frame: Up to 24 hours after surgery]
  • Pain intensity during deep breathing [Time frame: Up to 24 hours after surgery]
  • Total non-opioid analgesic consumption [Time frame: Up to 24 hours after surgery]
  • Overall satisfaction with postoperative pain control [Time frame: Up to 24 hours after surgery]
  • Incidence of analgesic-related adverse events [Time frame: Up to 24 hours after surgery]
  • Incentive spirometry performance [Time frame: Within 30 minutes after PACU arrival]
  • Incidence of postoperative atelectasis [Time frame: Up to 24 hours after surgery]
  • Distribution of sensory block [Time frame: At 30 minutes after PACU admission]
  • Sleep quality [Time frame: Night of surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Supportive care

Study locations

South Korea · 1 center
  • Seoul National University Hospital — Seoul

Identifiers

NCT: NCT07262944 · 2509-015-1674

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗