EOI Block in Otoplasty With Rib Cartilage Graft

Effect of Ultrasound-Guided External Oblique Intercostal Fascial Plane Block in Pediatric Patients Undergoing 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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain, Acute
• Intervention / Treatment: Procedure: Ultrasound-guided External Oblique Intercostal (EOI) Fascial Plane Block; Procedure: Standard postoperative pain management (no EOI block)

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jung-Bin Park, MDPhD; Phone Number: 820220723664; Email: jb4001@snu.ac.kr

Study Locations

• South Korea
  • Seoul, South Korea
    • Recruiting
    • Seoul National University Hospital
    • Contact: Young-Eun Jang, MD, PhD; Phone Number: 82-2-2072-3650; Email: na0ag2@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EOI block group; 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.	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.
Active Comparator: Control group (No 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total opioid consumption 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).	Within 24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity at rest	Pain intensity at rest assessed using the Numerical Rating Scale (NRS, 0-10; higher scores = worse pain)	Up to 24 hours after surgery
Pain intensity during deep breathing	Pain intensity during deep breathing assessed using the Numerical Rating Scale (NRS, 0-10; higher scores = worse pain)	Up to 24 hours after surgery
Total non-opioid analgesic consumption	Total consumption of non-opioid analgesics (e.g., acetaminophen, NSAIDs) within 24 hours after surgery	Up to 24 hours after surgery
Overall satisfaction with postoperative pain control	Overall patient satisfaction with postoperative pain control assessed using a 0-100 satisfaction scale (higher scores = better satisfaction)	Up to 24 hours after surgery
Incidence of analgesic-related adverse events	Incidence of adverse events related to analgesics (nausea, vomiting, pruritus, dizziness, constipation, dry mouth, etc.)	Up to 24 hours after surgery
Incentive spirometry performance	Performance on incentive spirometry measured as the number of balls lifted at 30 minutes after PACU admission (Unit of Measure: number of balls (count))	Within 30 minutes after PACU arrival
Incidence of postoperative atelectasis	Presence or absence of atelectasis evaluated on chest X-ray approximately 24 hours postoperatively	Up to 24 hours after surgery
Distribution of sensory block	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).	At 30 minutes after PACU admission
Sleep quality	Quality of sleep on the night of operation assessed on a 0-100 scale (0 = very poor, 100 = excellent).	Night of surgery

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): August 30, 2028

Study Registration Dates

• First Submitted: November 13, 2025
• First Submitted That Met QC Criteria: November 28, 2025
• First Posted (Estimated): December 4, 2025

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: November 28, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative
• Other Study ID Numbers: 2509-015-1674

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No