Menu
Recruiting NCT07119346

EOI Block for Laparoscopic Gastrostomy

No phase Interventional Gastrostomy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: EOI block, sham block.
Who it may be relevant to
Registry conditions: Gastrostomy. Basic parameters: 3 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Effect of Ultrasound-guided External Oblique Intercostal Fascial Plane Block in Pediatric Patients Undergoing Laparoscopic Gastrostomy: A Prospective Randomized Controlled Trial

Overview

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

  • Procedure EOI block
    EOI block with 0.25% ropivacaine 1 mL/kg (max 40 mL) bilaterally under ultrasound guidance
  • Procedure sham block
    Sham block with equal volume of normal saline bilaterally under ultrasound guidance

Primary outcome measures

  • Percent change in heart rate at surgical incision [Time frame: At surgical incision (baseline immediately before incision and within 10 minutes after incision).]
Secondary outcome measures (11)
  • 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 [Time frame: Up to 24 hours after surgery.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

South Korea · 1 center
  • Seoul National University Children's Hospital — Seoul

Identifiers

NCT: NCT07119346 · 2505-109-1643

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗