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

May 3, 2022 updated by: Jin-Tae Kim, Seoul National University Hospital
The purpose of this study is to evaluate the efficacy of erector spinae plane (ESP) block in children after pectus excavatum repair (nuss procedure).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 7 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Regional analgesia using 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.
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.
NO_INTERVENTION: Control
After pectus excavatum is done, intravenous patient controlled analgesia device with fentanyl is connected. No regional block is performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain score
Time Frame: 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.
1 hour after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 10, 2020

Primary Completion (ANTICIPATED)

September 30, 2023

Study Completion (ANTICIPATED)

December 30, 2023

Study Registration Dates

First Submitted

September 3, 2019

First Submitted That Met QC Criteria

September 6, 2019

First Posted (ACTUAL)

September 9, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 5, 2022

Last Update Submitted That Met QC Criteria

May 3, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H1907-087-1049

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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