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

Primary Purpose

Pectus Excavatum

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Erector spinae plane block
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pectus Excavatum

Eligibility Criteria

3 Years - 7 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul national university hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Regional analgesia using erector spinae plane block

Control

Arm Description

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.

After pectus excavatum is done, intravenous patient controlled analgesia device with fentanyl is connected. No regional block is performed.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Fentanyl dosage (mcg/kg)
Total dosage of fentanyl used postoperatively via patient controlled analgesia (mcg/kg)
Dose of rescue analgesics (mg/kg)
If additional analgesics are required due to uncontrolled pain, intravnous acetaminophen and ketocin can be administered.
Plasma concentration of ropivacaine
Plasma concentration of ropivacaine after injection

Full Information

First Posted
September 3, 2019
Last Updated
May 3, 2022
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04081922
Brief Title
Postoperative Analgesia With Erector Spinae Plane Block After Pectus Excavatum Repair in Children
Official Title
Postoperative Analgesia With Erector Spinae Plane Block After Pectus Excavatum Repair in Children
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 10, 2020 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pectus Excavatum

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Regional analgesia using erector spinae plane block
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
After pectus excavatum is done, intravenous patient controlled analgesia device with fentanyl is connected. No regional block is performed.
Intervention Type
Procedure
Intervention Name(s)
Erector spinae plane block
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain score
Description
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
Secondary Outcome Measure Information:
Title
Fentanyl dosage (mcg/kg)
Description
Total dosage of fentanyl used postoperatively via patient controlled analgesia (mcg/kg)
Time Frame
until hospital discharge (postoperative day 3)
Title
Dose of rescue analgesics (mg/kg)
Description
If additional analgesics are required due to uncontrolled pain, intravnous acetaminophen and ketocin can be administered.
Time Frame
until hospital discharge (postoperative day 3
Title
Plasma concentration of ropivacaine
Description
Plasma concentration of ropivacaine after injection
Time Frame
5, 10, 20, 30, 60, 120 minutes after injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jin-Tae Kim, MD, PhD
Phone
82-2-2072-3661
Email
jintae73@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin-Tae Kim, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul national university hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin-Tae Kim, MD, PhD
Phone
+82-2-2072-3295
Email
jintae73@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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