Postoperative Pain, AcuteNCT07262944
EOI Block in Otoplasty With Rib Cartilage Graft
A study testing Ultrasound-guided External Oblique Intercostal (EOI) Fascial Plane Block and Standard postoperative pain management (no EOI block) in people with Postoperative Pain, Acute, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Postoperative Pain, Acute
- What is being tested?
- Ultrasound-guided External Oblique Intercostal (EOI) Fascial Plane Block and Standard postoperative pain management (no EOI block)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Dec 2026to 30 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- - 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
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Young-Eun Jang, MD, PhD, 82-2-2072-3650, na0ag2@hotmail.com
About this study
Official title: 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.
- Conditions
- Postoperative Pain, Acute
- Being tested
- Ultrasound-guided External Oblique Intercostal (EOI) Fascial Plane Block, Standard postoperative pain management (no EOI block)
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided External Oblique Intercostal (EOI) Fascial Plane BlockProcedure or surgery
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 or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| EOI block group | Experimental | 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. Receives: Procedure: Ultrasound-guided External Oblique Intercostal (EOI) Fascial Plane Block |
| Control group (No block) | Active comparator | 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. Receives: Procedure: Standard postoperative pain management (no EOI block) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Within 24 hours after surgery
Secondary outcomes (9)
Pain intensity at rest
Pain intensity at rest assessed using the Numerical Rating Scale (NRS, 0-10; higher scores = worse pain)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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.)
Measured: 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))
Measured: Within 30 minutes after PACU arrival
Incidence of postoperative atelectasis
Presence or absence of atelectasis evaluated on chest X-ray approximately 24 hours postoperatively
Measured: 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).
Measured: 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).
Measured: Night of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start1 Dec 2026 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion30 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain, AcuteStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young-Eun Jang, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07262944
- Sponsor's protocol ID
- 2509-015-1674
- Status last verified
- Nov 2025
- First submitted
- 13 Nov 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ultrasound-Guided External Oblique Intercostal Fascial Plane Block in Pediatric Patients Undergoing Otoplasty With Rib Cartilage Graft
- ClinicalTrials.gov ID
- NCT07262944
- Acronym / sponsor ID
- 2509-015-1674
- Conditions
- Postoperative Pain, Acute
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 30 Aug 2028 (estimated)
- First posted
- 4 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EOI block group | Experimental | Procedure: Ultrasound-guided External Oblique Intercostal (EOI) Fascial Plane BlockParticipants 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. |
| Control group (No block) | Active comparator | 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. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- - 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound-guided External Oblique Intercostal (EOI) Fascial Plane BlockUnder 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. | Procedure or surgery | EOI block group |
| 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. | Procedure or surgery | Control group (No block) |
Primary outcome
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).
9 secondary outcomes
Pain intensity at rest
Time frame: Up to 24 hours after surgery
Pain intensity during deep breathing
Time frame: Up to 24 hours after surgery
Total non-opioid analgesic consumption
Time frame: Up to 24 hours after surgery
Overall satisfaction with postoperative pain control
Time frame: Up to 24 hours after surgery
Incidence of analgesic-related adverse events
Time frame: Up to 24 hours after surgery
Incentive spirometry performance
Time frame: Within 30 minutes after PACU arrival
Incidence of postoperative atelectasis
Time frame: Up to 24 hours after surgery
Distribution of sensory block
Time frame: At 30 minutes after PACU admission
Sleep quality
Time frame: Night of surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided External Oblique Intercostal (EOI) Fascial Plane Block and Standard postoperative pain management (no EOI block) in people with Postoperative Pain, Acute, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jung-Bin Park, MDPhD (820220723664, jb4001@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total opioid consumption within 24 hours after surgery (time frame: Within 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.