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EOI Block for Laparoscopic Gastrostomy

ConditionGastrostomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-17
SponsorSeoul National University Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Unstable vital signs

Trial design

Design model

Parallel

Treatments tested in this trial

  • EOI block

    Procedure/Surgery

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

  • sham block

    Procedure/Surgery

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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: EOI block groupExperimental treatment 1 intervention
Group B: control groupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percent change in heart rate at surgical incision

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

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

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).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Seoul National University Hospital

Lead sponsor

Source ClinicalTrials.gov
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