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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity at rest | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jung-Bin Park, MDPhD | Contact | 820220723664 | jb4001@snu.ac.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | South Korea |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| 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. |
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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 | 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 | 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 | Incidence of adverse events related to analgesics (nausea, vomiting, pruritus, dizziness, constipation, dry mouth, etc.) | 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)) | Within 30 minutes after PACU arrival |
| Incidence of postoperative atelectasis | Presence or absence of atelectasis evaluated on chest X-ray approximately 24 hours postoperatively | 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). | 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). | Night of surgery |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |