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NCT Number: NCT07262944

EOI Block in Otoplasty With Rib Cartilage Graft

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.

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Key information

Conditions

Postoperative Pain, Acute Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, South Korea

Location status: Recruiting

Location contact

Young-Eun Jang, MD, PhD

CONTACT

[email protected]

82-2-2072-3650

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

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)

Procedure

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 outcomes

  1. Total opioid consumption within 24 hours after surgery

    Time frame: 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).

Secondary outcomes

  1. Pain intensity at rest

    Time frame: Up to 24 hours after surgery

    Pain intensity at rest assessed using the Numerical Rating Scale (NRS, 0-10; higher scores = worse pain)

  2. Pain intensity during deep breathing

    Time frame: Up to 24 hours after surgery

    Pain intensity during deep breathing assessed using the Numerical Rating Scale (NRS, 0-10; higher scores = worse pain)

  3. Total non-opioid analgesic consumption

    Time frame: Up to 24 hours after surgery

    Total consumption of non-opioid analgesics (e.g., acetaminophen, NSAIDs) within 24 hours after surgery

  4. Overall satisfaction with postoperative pain control

    Time frame: Up to 24 hours after surgery

    Overall patient satisfaction with postoperative pain control assessed using a 0-100 satisfaction scale (higher scores = better satisfaction)

  5. Incidence of analgesic-related adverse events

    Time frame: Up to 24 hours after surgery

    Incidence of adverse events related to analgesics (nausea, vomiting, pruritus, dizziness, constipation, dry mouth, etc.)

  6. Incentive spirometry performance

    Time frame: Within 30 minutes after PACU arrival

    Performance on incentive spirometry measured as the number of balls lifted at 30 minutes after PACU admission (Unit of Measure: number of balls (count))

  7. Incidence of postoperative atelectasis

    Time frame: Up to 24 hours after surgery

    Presence or absence of atelectasis evaluated on chest X-ray approximately 24 hours postoperatively

  8. Distribution of sensory block

    Time frame: At 30 minutes after PACU admission

    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).

  9. Sleep quality

    Time frame: Night of surgery

    Quality of sleep on the night of operation assessed on a 0-100 scale (0 = very poor, 100 = excellent).

Study contacts

Contact information is provided by the study sponsor or research team.

Jung-Bin Park, MDPhD

CONTACT

[email protected]

820220723664

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Dec 4, 2025
Registry last updated
Dec 4, 2025

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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