This randomized controlled trial will evaluate the efficacy of ultrasound-guided external oblique intercostal fascial plane (EOI) block in reducing intraoperative and postoperative pain in pediatric patients undergoing laparoscopic gastrostomy under general anesthesia. Forty patients aged 3-18 years will be randomly allocated to receive either bilateral EOI block with 0.25% ropivacaine or sham block with normal saline. Primary outcome is percent change in heart rate at surgical incision. Secondary outcomes include intraoperative fentanyl use, perioperative analgesic requirements, postoperative pain scores (r-Face, Legs, Activity, Cry, Consolability(r-FLACC) and Pediatric Pain Profile), Analgesia Nociception Index values, and analgesia-related adverse events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
40
EOI block with 0.25% ropivacaine 1 mL/kg (max 40 mL) bilaterally under ultrasound guidance
Sham block with equal volume of normal saline bilaterally under ultrasound guidance
Seoul National University Children's Hospital
Seoul, South Korea
RECRUITINGPercent change in heart rate at surgical incision
Post-incision HR - Pre-incision HR) / Pre-incision HR × 100
Time frame: At surgical incision (baseline immediately before incision and within 10 minutes after incision).
Intraoperative fentanyl use
Time frame: From induction of anesthesia to end of surgery.
Percent change in mean arterial pressure at incision
Time frame: At surgical incision (baseline immediately before incision and within 10 minutes after incision).
Intraoperative max-min heart rate
Time frame: Intraoperative period (skin incision to end of surgery).
Intraoperative max-min mean arterial pressure
Time frame: Intraoperative period (skin incision to end of surgery).
ANI time-weighted average outside target (50-80)
Time frame: From induction of anesthesia to end of anesthesia (arrival to PACU).
r-Face, Legs, Activity, Cry, Consolability pain scores
Time frame: At PACU 15 minutes and 30 minutes; and at 1, 3, 6, and 24 hours after surgery.
Pediatric Pain Profile score
Time frame: 24 hours after surgery.
analgesia nociception index (ANIm) values in PACU
Time frame: At 15 and 30 minutes after PACU arrival.
Non-opioid analgesic consumption (mg/kg)
Time frame: From end of surgery to 24 hours postoperatively.
Opioid analgesic consumption (mcg/kg)
Time frame: From end of surgery to 24 hours postoperatively.
Analgesic-related adverse effects
nausea, vomiting, pruritus
Time frame: Up to 24 hours after surgery.
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