GastrostomyNCT07119346
EOI Block for Laparoscopic Gastrostomy
A study testing EOI block in people with Gastrostomy, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Gastrostomy
- What is being tested?
- EOI block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2025to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Scheduled for laparoscopic gastrostomy at Seoul National University Children's Hospital
- Age ≥3 and <18 years
Who cannot join
- Unstable vital signs
- Contraindications to ropivacaine or opioids
- Severe hepatic or renal dysfunction
- Other investigator-determined ineligibility
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Children's Hospital
Seoul, 110-744
Jin-Tae Kim, M.D.,Ph.D., 0220723664 ext. 82, jb4001@snu.ac.kr
About this study
Official title: Effect of Ultrasound-guided External Oblique Intercostal Fascial Plane Block in Pediatric Patients Undergoing Laparoscopic Gastrostomy: A Prospective Randomized Controlled 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.
- Conditions
- Gastrostomy
- Being tested
- EOI block, sham block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EOI blockProcedure or surgery
EOI block with 0.25% ropivacaine 1 mL/kg (max 40 mL) bilaterally under ultrasound guidance
sham blockProcedure or surgery
Sham block with equal volume of normal saline bilaterally under ultrasound guidance
| Study group | Role | What they receive |
|---|---|---|
| EOI block group | Experimental | Not described Receives: Procedure: EOI block |
| control group | Sham comparator | Not described Receives: Procedure: sham block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in heart rate at surgical incision
Post-incision HR - Pre-incision HR) / Pre-incision HR × 100
Measured: At surgical incision (baseline immediately before incision and within 10 minutes after incision).
Secondary outcomes (11)
Intraoperative fentanyl use
Measured: From induction of anesthesia to end of surgery.
Percent change in mean arterial pressure at incision
Measured: At surgical incision (baseline immediately before incision and within 10 minutes after incision).
Intraoperative max-min heart rate
Measured: Intraoperative period (skin incision to end of surgery).
Intraoperative max-min mean arterial pressure
Measured: Intraoperative period (skin incision to end of surgery).
ANI time-weighted average outside target (50-80)
Measured: From induction of anesthesia to end of anesthesia (arrival to PACU).
r-Face, Legs, Activity, Cry, Consolability pain scores
Measured: At PACU 15 minutes and 30 minutes; and at 1, 3, 6, and 24 hours after surgery.
Pediatric Pain Profile score
Measured: 24 hours after surgery.
analgesia nociception index (ANIm) values in PACU
Measured: At 15 and 30 minutes after PACU arrival.
Non-opioid analgesic consumption (mg/kg)
Measured: From end of surgery to 24 hours postoperatively.
Opioid analgesic consumption (mcg/kg)
Measured: From end of surgery to 24 hours postoperatively.
Analgesic-related adverse effects
nausea, vomiting, pruritus
Measured: Up to 24 hours after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study startAug 2025 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastrostomyStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07119346
- Sponsor's protocol ID
- 2505-109-1643
- Status last verified
- Aug 2025
- First submitted
- 11 Aug 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ultrasound-guided External Oblique Intercostal Fascial Plane Block in Pediatric Patients Undergoing Laparoscopic Gastrostomy: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07119346
- Acronym / sponsor ID
- 2505-109-1643
- Conditions
- Gastrostomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 13 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EOI block group | Experimental | Procedure: EOI block |
| control group | Sham comparator | Procedure: sham block |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Scheduled for laparoscopic gastrostomy at Seoul National University Children's Hospital
- Age ≥3 and <18 years
Key exclusion criteria (4 listed)
- Unstable vital signs
- Contraindications to ropivacaine or opioids
- Severe hepatic or renal dysfunction
- Other investigator-determined ineligibility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EOI blockEOI block with 0.25% ropivacaine 1 mL/kg (max 40 mL) bilaterally under ultrasound guidance | Procedure or surgery | EOI block group |
| sham blockSham block with equal volume of normal saline bilaterally under ultrasound guidance | Procedure or surgery | control group |
Primary outcome
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
11 secondary outcomes
Intraoperative fentanyl use
Time frame: From induction of anesthesia to end of surgery.
Percent change in mean arterial pressure at incision
Time frame: At surgical incision (baseline immediately before incision and within 10 minutes after incision).
Intraoperative max-min heart rate
Time frame: Intraoperative period (skin incision to end of surgery).
Intraoperative max-min mean arterial pressure
Time frame: Intraoperative period (skin incision to end of surgery).
ANI time-weighted average outside target (50-80)
Time frame: From induction of anesthesia to end of anesthesia (arrival to PACU).
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.
Pediatric Pain Profile score
Time frame: 24 hours after surgery.
analgesia nociception index (ANIm) values in PACU
Time frame: At 15 and 30 minutes after PACU arrival.
Non-opioid analgesic consumption (mg/kg)
Time frame: From end of surgery to 24 hours postoperatively.
Opioid analgesic consumption (mcg/kg)
Time frame: From end of surgery to 24 hours postoperatively.
Analgesic-related adverse effects
Time frame: Up to 24 hours after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EOI block in people with Gastrostomy, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in heart rate at surgical incision (time frame: At surgical incision (baseline immediately before incision and within 10 minutes after incision).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.