Actively Recruiting

Phase Not Applicable
Age: 13Years - 18Years
All Genders
ID07262944

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

Led by Seoul National University Hospital · Updated on 2025-12-04

60

Participants Needed

1

Research Sites

12 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate the effect of an ultrasound-guided external oblique intercostal (EOI) fascial plane block on pain control and recovery in children aged 13 to 18 years undergoing otoplasty with a rib cartilage graft under general anesthesia. The study compares the EOI block to no block in managing postoperative pain, focusing on total opioid use within 24 hours after surgery as the primary outcome. Secondary outcomes include pain scores, breathing exercise performance, lung complications, and patient satisfaction. Participants will be randomly assigned to one of two groups. One group will receive the EOI block using 0.2% ropivacaine injected at the 8th-9th intercostal space under ultrasound guidance at the end of surgery. The other group will not receive the block but will have the same general anesthesia and postoperative pain management with intravenous patient-controlled analgesia using fentanyl. The study involves a triple-blind randomized controlled design. During the study, participants will be monitored for opioid consumption, pain intensity at rest and during deep breathing, non-opioid analgesic use, satisfaction with pain control, and adverse events up to 24 hours after surgery. Additional assessments include incentive spirometry performance shortly after recovery, incidence of postoperative atelectasis, sensory block distribution, and sleep quality on the night of surgery. The total participation period covers the immediate postoperative phase up to 24 hours.

CONDITIONS

Brief Title

EOI Block in Otoplasty With Rib Cartilage Graft

Who Can Participate

Age: 13Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Day of surgery

Participants undergo otoplasty with rib cartilage graft under general anesthesia. At the end of surgery, some participants receive an ultrasound-guided external oblique intercostal (EOI) fascial plane block for postoperative pain relief, while others receive standard postoperative pain management including intravenous patient-controlled analgesia with fentanyl.

1 surgical procedure and immediate postoperative monitoring

Post-operative Follow-up

Duration - Up to 24 hours after surgery

Participants are observed for up to 24 hours after surgery to assess pain intensity, opioid and non-opioid analgesic consumption, analgesic-related adverse events, and overall satisfaction with pain control. Additional assessments include incentive spirometry and monitoring for postoperative atelectasis.

Continuous monitoring during hospital stay up to 24 hours

Trial Site Locations

Total: 1 location

1

Seoul National University Hospital

Seoul, South Korea

Actively Recruiting

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Research Team

J

Jung-Bin Park, MDPhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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