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

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy of erector spinae plane (ESP) block in children after pectus excavatum repair (nuss procedure).

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

Conditions
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Pectus Excavatum

Intervention / Treatment
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* Procedure: Erector spinae plane block


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Regional analgesia using erector spinae plane block<br>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<br>* 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.<br>|
| No Intervention: Control<br>After pectus excavatum is done, intravenous patient controlled analgesia device with fentanyl is connected. No regional block is performed. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 hour after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fentanyl dosage (mcg/kg) | Total dosage of fentanyl used postoperatively via patient controlled analgesia (mcg/kg) | 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. | until hospital discharge (postoperative day 3 | 
| Plasma concentration of ropivacaine | Plasma concentration of ropivacaine after injection | 5, 10, 20, 30, 60, 120 minutes after injection |