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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EOI block group | Experimental |
| |
| control group | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EOI block | Procedure | EOI block with 0.25% ropivacaine 1 mL/kg (max 40 mL) bilaterally under ultrasound guidance |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in heart rate at surgical incision | Post-incision HR - Pre-incision HR) / Pre-incision HR × 100 | At surgical incision (baseline immediately before incision and within 10 minutes after incision). |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative fentanyl use | From induction of anesthesia to end of surgery. | |
| Percent change in mean arterial pressure at incision | At surgical incision (baseline immediately before incision and within 10 minutes after incision). |
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Inclusion Criteria:
Age ≥3 and <18 years
Exclusion Criteria:
Contraindications to ropivacaine or opioids
Severe hepatic or renal dysfunction
Other investigator-determined ineligibility
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Children's Hospital | Recruiting | Seoul | 110-744 | South Korea |
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| sham block | Procedure | Sham block with equal volume of normal saline bilaterally under ultrasound guidance |
|
| 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. |
| Pediatric Pain Profile score | 24 hours after 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 | nausea, vomiting, pruritus | Up to 24 hours after surgery. |