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Postoperative Analgesia With Erector Spinae Plane Block After Pectus Excavatum Repair in Children

Postoperative Analgesia With Erector Spinae Plane Block After Pectus Excavatum Repair in Children

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04081922
Enrollment
30
Registered
2019-09-09
Start date
2020-02-10
Completion date
2023-12-30
Last updated
2022-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pectus Excavatum

Brief 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).

Interventions

PROCEDUREErector spinae plane block

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.

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
3 Years to 7 Years
Healthy volunteers
No

Inclusion criteria

* 30 children aged between 3 and 7 years who undergo Nuss bar insertion due to Pectus excavatum

Exclusion criteria

* Allergy to opioid * Allergy to local anesthetics * Disease in heart, lung, kidney, and liver * Coagulation disorder * Disease in central and peripheral nervous system

Design outcomes

Primary

MeasureTime frameDescription
Pain score1 hour after surgeryThe 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.

Secondary

MeasureTime frameDescription
Fentanyl dosage (mcg/kg)until hospital discharge (postoperative day 3)Total dosage of fentanyl used postoperatively via patient controlled analgesia (mcg/kg)
Dose of rescue analgesics (mg/kg)until hospital discharge (postoperative day 3If additional analgesics are required due to uncontrolled pain, intravnous acetaminophen and ketocin can be administered.
Plasma concentration of ropivacaine5, 10, 20, 30, 60, 120 minutes after injectionPlasma concentration of ropivacaine after injection

Countries

South Korea

Contacts

Primary ContactJin-Tae Kim, MD, PhD
jintae73@gmail.com82-2-2072-3661

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026