EOI Block in Otoplasty With Rib Cartilage Graft
ConditionPostoperative Pain, Acute
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-18
SponsorSeoul National University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
- 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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Ultrasound-guided External Oblique Intercostal (EOI) Fascial Plane Block
Procedure/SurgeryUnder 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/SurgeryParticipants 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: EOI block groupExperimental treatment 1 intervention
Group B: Control group (No block)Active comparator 1 intervention
Trial outcomes
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).
Time frame
Within 24 hours after surgerySecondary outcomes
1
Pain intensity at rest
Pain intensity at rest assessed using the Numerical Rating Scale (NRS, 0-10; higher scores = worse pain)
Time frame
Up to 24 hours after surgery2
Pain intensity during deep breathing
Pain intensity during deep breathing assessed using the Numerical Rating Scale (NRS, 0-10; higher scores = worse pain)
Time frame
Up to 24 hours after surgery3
Total non-opioid analgesic consumption
Total consumption of non-opioid analgesics (e.g., acetaminophen, NSAIDs) within 24 hours after surgery
Time frame
Up to 24 hours after surgery4
Overall satisfaction with postoperative pain control
Overall patient satisfaction with postoperative pain control assessed using a 0-100 satisfaction scale (higher scores = better satisfaction)
Time frame
Up to 24 hours after surgerySponsors and contacts
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Source ClinicalTrials.gov