EOI Block in Otoplasty With Rib Cartilage Graft

Seoul National University

Status: Enrolling

Conditions: Postoperative Pain, Acute

Treatments: Procedure: Standard postoperative pain management (no EOI block); Procedure: Ultrasound-guided External Oblique Intercostal (EOI) Fascial Plane Block

Study type: Interventional

Funder types: Other

Identifiers

NCT07262944

2509-015-1674

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 13 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

EOI block group

Experimental group

Description:

Participants will receive ultrasound-guided external oblique intercostal (EOI) fascial plane block at the end of surgery. Under general anesthesia, a linear ultrasound probe (6-13 MHz) will be placed transversely at the 8th-9th intercostal space along the anterior axillary line. A 22-gauge, 50-80 mm needle will be advanced in-plane into the fascial plane between the external oblique and intercostal muscles, and 0.2% ropivacaine 0.5 mL/kg (maximum 30 mL) will be injected. Postoperative pain management will include intravenous patient-controlled analgesia (IV-PCA) with fentanyl.

Treatment:

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

Control group (No block)

Active Comparator group

Description:

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.

Treatment:

Procedure: Standard postoperative pain management (no EOI block)