External oblique intercostal (EOI) block to reduce pain after 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 trial will test whether an ultrasound-guided EOI nerve block with 0.2% ropivacaine reduces opioid use and pain in patients aged 13–18 having otoplasty with rib cartilage graft.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 13 Years to 18 Years |
| Sex | All |
| Sponsor | Seoul National University Hospital Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT07262944 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial at Seoul National University Children's Hospital will assign 13–18-year-old patients undergoing otoplasty with rib cartilage graft to receive either an ultrasound-guided external oblique intercostal (EOI) fascial plane block with 0.2% ropivacaine or no block in addition to standard anesthesia and postoperative care. The primary outcome is total opioid consumption in the first 24 hours after surgery. Secondary outcomes include numeric rating scale pain scores, incentive spirometry performance, incidence of atelectasis, and patient satisfaction. The study will determine whether adding the EOI block improves early pain control and respiratory recovery after chest-wall harvest for otoplasty.
Who should consider this trial
Good fit: Ideal candidates are 13–18-year-old patients undergoing otoplasty with rib cartilage graft under general anesthesia at Seoul National University Children's Hospital who provide assent and whose parent or guardian provides written informed consent.
Not a fit: Patients with known hypersensitivity to ropivacaine or other amide local anesthetics, opioid allergy, local infection at the injection site, unstable vital signs, severe renal or hepatic dysfunction, sepsis, or other conditions judged unsuitable by the investigator are unlikely to receive benefit from this intervention.
Why it matters
Potential benefit: If effective, the EOI block could lower opioid requirements and pain after surgery, speeding recovery and improving satisfaction for adolescent otoplasty patients.
How similar studies have performed: Other interfascial plane blocks and EOI blocks have shown pain-reducing effects in thoracic and chest-wall procedures, but applying an EOI block specifically for pediatric otoplasty with rib graft is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Seoul
- Seoul National University Hospital — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Jung-Bin Park, MDPhD
- Email: jb4001@snu.ac.kr
- Phone: 820220723664
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.