EOI Block for Laparoscopic Gastrostomy
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Gastrostomy
In brief
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.
Key facts
- Study ID
- NCT07119346
- Run by
- Seoul National University Hospital
- People needed
- 40
- Starts
- 2025-08-01
- Expected to finish
- 2028-05-01
- Last updated by the study team
- 2025-08-13
Who can join
Age: 3 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Scheduled for laparoscopic gastrostomy at Seoul National University Children's Hospital
- Age ≥3 and <18 years
You may not qualify if…
- Unstable vital signs
- Contraindications to ropivacaine or opioids
- Severe hepatic or renal dysfunction
- Other investigator-determined ineligibility
Where it is running
- Seoul National University Children's Hospital — Seoul, South Korea (enrolling)
Full record on ClinicalTrials.gov
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