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

Not Applicable

• Conditions: Pectus Excavatum
• Interventions: Procedure: Erector spinae plane block

• Registration Number: NCT04081922
• Lead Sponsor: Seoul National University Hospital

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-03
• Study First Submitted QC: 2019-09-06
• Study First Posted: 2019-09-09
• Study Start: 2020-02-10
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-03
• Last Update Posted: 2022-05-05
• Primary Completion: 2023-09-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Regional analgesia using erector spinae plane block	Erector spinae plane block	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.

Primary Outcome Measures

Name	Time	Method
Pain score	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.

Secondary Outcome Measures

Name	Time	Method
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 3	If additional analgesics are required due to uncontrolled pain, intravnous acetaminophen and ketocin can be administered.
Plasma concentration of ropivacaine	5, 10, 20, 30, 60, 120 minutes after injection	Plasma concentration of ropivacaine after injection

Trial Locations

Locations (1)

Seoul national university hospital; 🇰🇷 Seoul, Korea, Republic of