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NCT Number: NCT07119346

EOI Block for Laparoscopic Gastrostomy

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.

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Key information

Conditions

Gastrostomy

Age range

3 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Children's Hospital

Seoul, 110-744, South Korea

Location status: Recruiting

Location contact

Jin-Tae Kim, M.D.,Ph.D.

CONTACT

[email protected]

0220723664 ext. 82

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EOI block

Procedure

EOI block with 0.25% ropivacaine 1 mL/kg (max 40 mL) bilaterally under ultrasound guidance

Sham Block

Procedure

Sham block with equal volume of normal saline bilaterally under ultrasound guidance

Primary outcomes

  1. Percent change in heart rate at surgical incision

    Time frame: At surgical incision (baseline immediately before incision and within 10 minutes after incision).

    Post-incision HR - Pre-incision HR) / Pre-incision HR × 100

Secondary outcomes

  1. Intraoperative fentanyl use

    Time frame: From induction of anesthesia to end of surgery.

  2. Percent change in mean arterial pressure at incision

    Time frame: At surgical incision (baseline immediately before incision and within 10 minutes after incision).

  3. Intraoperative max-min heart rate

    Time frame: Intraoperative period (skin incision to end of surgery).

  4. Intraoperative max-min mean arterial pressure

    Time frame: Intraoperative period (skin incision to end of surgery).

  5. ANI time-weighted average outside target (50-80)

    Time frame: From induction of anesthesia to end of anesthesia (arrival to PACU).

  6. 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.

  7. Pediatric Pain Profile score

    Time frame: 24 hours after surgery.

  8. analgesia nociception index (ANIm) values in PACU

    Time frame: At 15 and 30 minutes after PACU arrival.

  9. Non-opioid analgesic consumption (mg/kg)

    Time frame: From end of surgery to 24 hours postoperatively.

  10. Opioid analgesic consumption (mcg/kg)

    Time frame: From end of surgery to 24 hours postoperatively.

  11. Analgesic-related adverse effects

    Time frame: Up to 24 hours after surgery.

    nausea, vomiting, pruritus

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Aug 13, 2025
Registry last updated
Aug 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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