EOI Block in Otoplasty With Rib Cartilage Graft

NCT07262944 | Recruiting

• 1 other identifier: 2509-015-1674
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Pain intensity at rest

  Up to 24 hours after surgery

• Pain intensity during deep breathing

  Up to 24 hours after surgery

• Total non-opioid analgesic consumption

  Up to 24 hours after surgery

• Overall satisfaction with postoperative pain control

  Up to 24 hours after surgery

• Incidence of analgesic-related adverse events

  Up to 24 hours after surgery

Study Arms (2)

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.

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.

Procedure: Standard postoperative pain management (no EOI block)

Interventions

Standard postoperative pain management (no EOI block) PROCEDURE

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.

Control group (No block)

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

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.

EOI block group

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Jung-Bin Park, MDPhD

CONTACT

820220723664; jb4001@snu.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: December 4, 2025
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): August 30, 2028
• Last Updated: December 4, 2025

Record last verified: 2025-11

Locations

KR (1)