An interventional study of Erector spinae plane block in Pectus Excavatum, sponsored by Seoul National University Hospital. Status unknown at 1 site in Korea, Republic of. Open to participants aged 3 Years to 7 Years. Per ClinicalTrials.gov, last updated 2022-05-05.
Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy of erector spinae plane (ESP) block in children after pectus excavatum repair (nuss procedure).
79 studies on the registry are indexed under Funnel Chest; 10 are open to participants now.
This study's planned enrollment of 30 is below the median of 40 across 46 interventional studies indexed under Funnel Chest.
Browse Funnel Chest studies →Seoul National University Hospital is the lead sponsor of 1,900 studies on the registry; 274 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
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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.
Procedure: Erector spinae plane block
After pectus excavatum is done, intravenous patient controlled analgesia device with fentanyl is connected. No regional block is performed.
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.
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.
Time frame: 1 hour after surgery
Fentanyl dosage (mcg/kg)
Total dosage of fentanyl used postoperatively via patient controlled analgesia (mcg/kg)
Time frame: 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.
Time frame: until hospital discharge (postoperative day 3
Plasma concentration of ropivacaine
Plasma concentration of ropivacaine after injection
Time frame: 5, 10, 20, 30, 60, 120 minutes after injection
Plan to share: Undecided
No publications or documents are linked to this record.
Started Feb 2020 (actual). Primary completion is estimated for Sep 2023, 43 months after the start.
Of 31 interventional studies with no phase under Funnel Chest, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 68. This study's planned 43 months is close to that.
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This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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