Postoperative Pain, Acute
Conditions
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.
Interventions
PROCEDUREUltrasound-guided External Oblique Intercostal (EOI) Fascial Plane Block
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.
PROCEDUREStandard 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.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
13 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total opioid consumption within 24 hours after surgery | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity during deep breathing | Up to 24 hours after surgery | Pain intensity during deep breathing assessed using the Numerical Rating Scale (NRS, 0-10; higher scores = worse pain) |
| Total non-opioid analgesic consumption | Up to 24 hours after surgery | Total consumption of non-opioid analgesics (e.g., acetaminophen, NSAIDs) within 24 hours after surgery |
| Overall satisfaction with postoperative pain control | Up to 24 hours after surgery | Overall patient satisfaction with postoperative pain control assessed using a 0-100 satisfaction scale (higher scores = better satisfaction) |
| Incidence of analgesic-related adverse events | Up to 24 hours after surgery | Incidence of adverse events related to analgesics (nausea, vomiting, pruritus, dizziness, constipation, dry mouth, etc.) |
| Pain intensity at rest | Up to 24 hours after surgery | Pain intensity at rest assessed using the Numerical Rating Scale (NRS, 0-10; higher scores = worse pain) |
| Incidence of postoperative atelectasis | Up to 24 hours after surgery | Presence or absence of atelectasis evaluated on chest X-ray approximately 24 hours postoperatively |
| Distribution of sensory block | At 30 minutes after PACU admission | 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). |
| Sleep quality | Night of surgery | Quality of sleep on the night of operation assessed on a 0-100 scale (0 = very poor, 100 = excellent). |
| Incentive spirometry performance | Within 30 minutes after PACU arrival | Performance on incentive spirometry measured as the number of balls lifted at 30 minutes after PACU admission (Unit of Measure: number of balls (count)) |
Countries
South Korea
Contacts
Primary ContactJung-Bin Park, MDPhD
Outcome results
None listed