Pectus ExcavatumNCT04081922
Postoperative Analgesia With Erector Spinae Plane Block After Pectus Excavatum Repair in Children
A study testing Erector spinae plane block in people with Pectus Excavatum, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the efficacy of erector spinae plane (ESP) block in children after pectus excavatum repair (nuss procedure). Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Pectus Excavatum
- What is being tested?
- Erector spinae plane block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Feb 2020to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 30 children aged between 3 and 7 years who undergo Nuss bar insertion due to Pectus excavatum
Who cannot join
- Allergy to opioid
- Allergy to local anesthetics
- Disease in heart, lung, kidney, and liver
- Coagulation disorder
- Disease in central and peripheral nervous system
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul national university hospital
Seoul, 03080
Jin-Tae Kim, MD, PhD, +82-2-2072-3295, jintae73@gmail.com
About this study
The purpose of this study is to evaluate the efficacy of erector spinae plane (ESP) block in children after pectus excavatum repair (nuss procedure).
- Conditions
- Pectus Excavatum
- Being tested
- Erector spinae plane block
- Medical subject headings
- Funnel Chest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector spinae plane blockProcedure or surgery
Using ultrasound, place the needle in the erector spinae fascia plane at T7-8 level. Then, 0.25% ropivacaine 0.5 ml is injected to confirm the needle location. After checking the location, 0.25% ropivacaine 0.5 ml/kg is administered. This procedure is repeated at contralateral side.
| Study group | Role | What they receive |
|---|---|---|
| Regional analgesia using erector spinae plane block | Experimental | After pectus excavatum is done, intravenous patient controlled analgesia device with fentanyl is connected. Then, regional analgesia is performed for additional analgesia; ultrasound guided erector spinae plane block is performed using 0.25% ropivacaine (total 1 ml/kg) bilaterally. Plasma concentration of ropivacaine at baseline, and 5, 10, 20, 30, 60, 120 minutes after ropivacaine injection will be measured. Receives: Procedure: Erector spinae plane block |
| Control | No intervention | After pectus excavatum is done, intravenous patient controlled analgesia device with fentanyl is connected. No regional block is performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
The Face, Legs, Activity, Cry, Consolability (FLACC) scale is used. FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.
Measured: 1 hour after surgery
Secondary outcomes (3)
Fentanyl dosage (mcg/kg)
Total dosage of fentanyl used postoperatively via patient controlled analgesia (mcg/kg)
Measured: until hospital discharge (postoperative day 3)
Dose of rescue analgesics (mg/kg)
If additional analgesics are required due to uncontrolled pain, intravnous acetaminophen and ketocin can be administered.
Measured: until hospital discharge (postoperative day 3
Plasma concentration of ropivacaine
Plasma concentration of ropivacaine after injection
Measured: 5, 10, 20, 30, 60, 120 minutes after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start10 Feb 2020
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pectus ExcavatumStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 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
- Investigators
- Jin-Tae Kim, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04081922
- Sponsor's protocol ID
- H1907-087-1049
- Status last verified
- May 2022
- First submitted
- 3 Sep 2019
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Analgesia With Erector Spinae Plane Block After Pectus Excavatum Repair in Children
- ClinicalTrials.gov ID
- NCT04081922
- Acronym / sponsor ID
- H1907-087-1049
- Conditions
- Pectus Excavatum
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 9 Sep 2019 (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.
The purpose of this study is to evaluate the efficacy of erector spinae plane (ESP) block in children after pectus excavatum repair (nuss procedure).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regional analgesia using erector spinae plane block | Experimental | Procedure: Erector spinae plane blockAfter pectus excavatum is done, intravenous patient controlled analgesia device with fentanyl is connected. Then, regional analgesia is performed for additional analgesia; ultrasound guided erector spinae plane block is performed using 0.25% ropivacaine (total 1 ml/kg) bilaterally. Plasma concentration of ropivacaine at baseline, and 5, 10, 20, 30, 60, 120 minutes after ropivacaine injection will be measured. |
| Control | No intervention | –After pectus excavatum is done, intravenous patient controlled analgesia device with fentanyl is connected. No regional block is performed. |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 30 children aged between 3 and 7 years who undergo Nuss bar insertion due to Pectus excavatum
Key exclusion criteria (5 listed)
- Allergy to opioid
- Allergy to local anesthetics
- Disease in heart, lung, kidney, and liver
- Coagulation disorder
- Disease in central and peripheral nervous system
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 |
|---|---|---|
| Erector spinae plane blockUsing ultrasound, place the needle in the erector spinae fascia plane at T7-8 level. Then, 0.25% ropivacaine 0.5 ml is injected to confirm the needle location. After checking the location, 0.25% ropivacaine 0.5 ml/kg is administered. This procedure is repeated at contralateral side. | Procedure or surgery | Regional analgesia using erector spinae plane block |
Primary outcome
Pain score
Time frame: 1 hour after surgery
The Face, Legs, Activity, Cry, Consolability (FLACC) scale is used. FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.
3 secondary outcomes
Fentanyl dosage (mcg/kg)
Time frame: until hospital discharge (postoperative day 3)
Dose of rescue analgesics (mg/kg)
Time frame: until hospital discharge (postoperative day 3
Plasma concentration of ropivacaine
Time frame: 5, 10, 20, 30, 60, 120 minutes after injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Jin-Tae Kim, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector spinae plane block in people with Pectus Excavatum, 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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 5 May 2022. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jin-Tae Kim, MD, PhD (82-2-2072-3661, jintae73@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score (time frame: 1 hour after surgery). 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 5 May 2022.