Actively Recruiting

Phase Not Applicable
Age: 3Years - 17Years
All Genders
ID07119346

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

Led by Seoul National University Hospital · Updated on 2025-08-13

40

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of an ultrasound-guided external oblique intercostal fascial plane (EOI) block to reduce pain during and after laparoscopic gastrostomy surgery in children ages 3 to 18 years. This randomized controlled trial compares the effects of the EOI block using ropivacaine against a sham block using normal saline to understand its impact on heart rate changes and pain management during surgery. Participants will be randomly assigned to receive either a bilateral EOI block with 0.25% ropivacaine or a sham block with normal saline, both performed under ultrasound guidance. The study measures include the percent change in heart rate at the time of surgical incision as the primary outcome, along with secondary outcomes such as fentanyl use during surgery, various pain scores, analgesia nociception index values, and any analgesia-related side effects. During the study, children's pain levels will be monitored at multiple time points after surgery using standardized pain scales. Researchers will also track the use of pain medications up to 24 hours post-operation and monitor for any adverse effects related to analgesia. The trial is conducted under general anesthesia, and heart rate and blood pressure changes will be recorded around the time of surgery to evaluate the intervention's effectiveness.

CONDITIONS

Brief Title

EOI Block for Laparoscopic Gastrostomy

Who Can Participate

Age: 3Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Scheduled for laparoscopic gastrostomy at Seoul National University Children's Hospital
  • Age 3 years or older and less than 18 years
Not Eligible

You will not qualify if you...

  • Unstable vital signs
  • Contraindications to ropivacaine or opioids
  • Severe hepatic or renal dysfunction
  • Other investigator-determined ineligibility

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Day of surgery

Participants undergo laparoscopic gastrostomy surgery with either the EOI block or a sham block under ultrasound guidance, followed by immediate post-operative monitoring.

1 surgical visit and monitoring in PACU for up to 30 minutes

Post-operative Follow-up

Duration - 24 hours after surgery

Participants are monitored for pain and analgesic use up to 24 hours after surgery.

Assessments at 15 and 30 minutes in PACU, and at 1, 3, 6, and 24 hours post-surgery

Trial Site Locations

Total: 1 location

1

Seoul National University Children's Hospital

Seoul, South Korea, 110-744

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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