EOI block to reduce pain during pediatric laparoscopic gastrostomy
Effect of Ultrasound-guided External Oblique Intercostal Fascial Plane Block in Pediatric Patients Undergoing Laparoscopic Gastrostomy: A Prospective Randomized Controlled Trial
This trial will test whether an ultrasound-guided external oblique intercostal (EOI) block with ropivacaine reduces pain during and after laparoscopic gastrostomy in children aged 3 to 18.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 3 Years to 17 Years |
| Sex | All |
| Sponsor | Seoul National University Hospital Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT07119346 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial will enroll 40 children aged 3–18 undergoing laparoscopic gastrostomy under general anesthesia and randomly assign them to bilateral ultrasound-guided EOI block with 0.25% ropivacaine or a sham block with saline. The primary outcome is percent change in heart rate at surgical incision as a proxy for intraoperative nociception. Secondary outcomes include intraoperative fentanyl consumption, perioperative analgesic requirements, postoperative pain scores (r-FLACC and Pediatric Pain Profile), Analgesia Nociception Index values, and analgesia-related adverse events. The trial is conducted at Seoul National University Children's Hospital and includes perioperative monitoring and follow-up for analgesic outcomes.
Who should consider this trial
Good fit: Children aged 3 to 18 scheduled for laparoscopic gastrostomy at Seoul National University Children's Hospital with stable vital signs and no contraindication to ropivacaine or opioids are ideal candidates.
Not a fit: Patients with unstable vital signs, severe hepatic or renal dysfunction, known allergy to local anesthetics or opioids, or other contraindications are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the EOI block could lower intra- and postoperative pain and reduce opioid requirements for children having laparoscopic gastrostomy.
How similar studies have performed: Abdominal wall plane blocks have shown analgesic and opioid-sparing benefits in adult and some pediatric surgeries, but the ultrasound-guided EOI block is relatively novel and pediatric evidence remains limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul
- Seoul National University Children's Hospital — Seoul, South Korea (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.