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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 17
Healthy Volunteers: f
View:

• Scheduled for laparoscopic gastrostomy at Seoul National University Children's Hospital

⁃ Age ≥3 and \<18 years

Locations
Other Locations
Republic of Korea
Seoul National University Children's Hospital
RECRUITING
Seoul
Time Frame
Start Date: 2025-08
Estimated Completion Date: 2028-05
Participants
Target number of participants: 40
Treatments
Experimental: EOI block group
Sham_comparator: control group
Related Therapeutic Areas
Sponsors
Leads: Seoul National University Hospital

This content was sourced from clinicaltrials.gov