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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04081922
Recruitment Status : Not yet recruiting
First Posted : September 9, 2019
Last Update Posted : November 8, 2019
Sponsor:
Information provided by (Responsible Party):
Jin-Tae Kim, 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).

Condition or disease Intervention/treatment Phase
Pectus Excavatum Procedure: Erector spinae plane block Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Postoperative Analgesia With Erector Spinae Plane Block After Pectus Excavatum Repair in Children
Estimated Study Start Date : November 30, 2019
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Fentanyl dosage (mcg/kg) [ Time Frame: until hospital discharge (postoperative day 3) ]
    Total dosage of fentanyl used postoperatively via patient controlled analgesia (mcg/kg)

  2. 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.

  3. Plasma concentration of ropivacaine [ Time Frame: 5, 10, 20, 30, 60, 120 minutes after injection ]
    Plasma concentration of ropivacaine after injection



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Ages Eligible for Study:   3 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04081922


Contacts
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Contact: Jin-Tae Kim, MD, PhD 82-2-2072-3661 jintae73@gmail.com

Locations
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Korea, Republic of
Seoul national university hospital
Seoul, Korea, Republic of, 03080
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Jin-Tae Kim, MD, PhD Seoul National University Hospital

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Responsible Party: Jin-Tae Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT04081922    
Other Study ID Numbers: H1907-087-1049
First Posted: September 9, 2019    Key Record Dates
Last Update Posted: November 8, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Funnel Chest
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Musculoskeletal Abnormalities
Congenital Abnormalities
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents