EOI Block in Otoplasty With Rib Cartilage Graft

November 28, 2025 updated by: Young-Eun Jang, Seoul National University Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • South Korea
      • Seoul, South Korea
        • Recruiting
        • Seoul National University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Within 24 hours after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
Up to 24 hours after surgery
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)
Up to 24 hours after surgery
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
Up to 24 hours after surgery
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)
Up to 24 hours after surgery
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.)
Up to 24 hours after surgery
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))
Within 30 minutes after PACU arrival
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
Up to 24 hours after surgery
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).
At 30 minutes after PACU admission
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).
Night of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 13, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 4, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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