Gastrostomy
Conditions
Brief summary
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.
Interventions
PROCEDUREEOI block
EOI block with 0.25% ropivacaine 1 mL/kg (max 40 mL) bilaterally under ultrasound guidance
PROCEDUREsham block
Sham block with equal volume of normal saline bilaterally under ultrasound guidance
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Scheduled for laparoscopic gastrostomy at Seoul National University Children's Hospital Age ≥3 and \<18 years
Exclusion criteria
* Unstable vital signs Contraindications to ropivacaine or opioids Severe hepatic or renal dysfunction Other investigator-determined ineligibility
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent change in heart rate at surgical incision | At surgical incision (baseline immediately before incision and within 10 minutes after incision). | Post-incision HR - Pre-incision HR) / Pre-incision HR × 100 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent change in mean arterial pressure at incision | At surgical incision (baseline immediately before incision and within 10 minutes after incision). | — |
| Intraoperative max-min heart rate | Intraoperative period (skin incision to end of surgery). | — |
| Intraoperative max-min mean arterial pressure | Intraoperative period (skin incision to end of surgery). | — |
| ANI time-weighted average outside target (50-80) | From induction of anesthesia to end of anesthesia (arrival to PACU). | — |
| r-Face, Legs, Activity, Cry, Consolability pain scores | At PACU 15 minutes and 30 minutes; and at 1, 3, 6, and 24 hours after surgery. | — |
| Intraoperative fentanyl use | From induction of anesthesia to end of surgery. | — |
| analgesia nociception index (ANIm) values in PACU | At 15 and 30 minutes after PACU arrival. | — |
| Non-opioid analgesic consumption (mg/kg) | From end of surgery to 24 hours postoperatively. | — |
| Opioid analgesic consumption (mcg/kg) | From end of surgery to 24 hours postoperatively. | — |
| Analgesic-related adverse effects | Up to 24 hours after surgery. | nausea, vomiting, pruritus |
| Pediatric Pain Profile score | 24 hours after surgery. | — |
Countries
South Korea
Outcome results
None listed