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

Pectus Excavatum Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04081922
• Other study ID #: H1907-087-1049
• Status: Recruiting
• Phase: N/A
• Start date: February 10, 2020
• Est. completion date: December 30, 2023

Study information

• Verified date: May 2022
• Source: Seoul National University Hospital
• Contact: Jin-Tae Kim, MD, PhD
• Phone: 82-2-2072-3661
• Email: jintae73[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Funnel Chest
• Pectus Excavatum

Intervention

Procedure:
• Erector 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul national university hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Fentanyl dosage (mcg/kg)	Total dosage of fentanyl used postoperatively via patient controlled analgesia (mcg/kg)	until hospital discharge (postoperative day 3)
Secondary	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
Secondary	Plasma concentration of ropivacaine	Plasma concentration of ropivacaine after injection	5, 10, 20, 30, 60, 120 minutes after injection