Effect of Ultrasound-Guided External Oblique Intercostal Fascial Plane Block in Pediatric Patients Undergoing Otoplasty With Rib Cartilage Graft
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Total opioid consumption within 24 hours after surgery
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 13 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts 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
- •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
Arms & Interventions
EOI block group
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.
Intervention: Ultrasound-guided External Oblique Intercostal (EOI) Fascial Plane Block (Procedure)
Control group (No 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.
Intervention: Standard postoperative pain management (no EOI block) (Procedure)
Outcomes
Primary Outcomes
Total opioid consumption within 24 hours after surgery
Time Frame: 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 Outcomes
- Total non-opioid analgesic consumption(Up to 24 hours after surgery)
- Pain intensity during deep breathing(Up to 24 hours after surgery)
- Overall satisfaction with postoperative pain control(Up to 24 hours after surgery)
- Incidence of postoperative atelectasis(Up to 24 hours after surgery)
- Distribution of sensory block(At 30 minutes after PACU admission)
- Sleep quality(Night of surgery)
- Pain intensity at rest(Up to 24 hours after surgery)
- Incentive spirometry performance(Within 30 minutes after PACU arrival)
- Incidence of analgesic-related adverse events(Up to 24 hours after surgery)
Investigators
Young-Eun Jang
professor
Seoul National University Hospital