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Regional Anesthesia Following Pediatric Cardiac Surgery

Primary Purpose

Atrial Septal Defect, Ventricular Septal Defect, Pain, Procedural

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Regional Anesthesia
Wound infiltration
Ropivacaine 0.2% Injectable Solution
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Septal Defect focused on measuring Regional anesthesia

Eligibility Criteria

undefined - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Children less than 18 years old Presenting for primary atrial septal defect or ventricular septal defect repair Informed consent / assent provided Exclusion Criteria: Patients on opioid therapy at the time of surgery History of sternotomy Planned postoperative intubation Current diagnosis of a chronic pain syndrome.

Sites / Locations

  • Duke University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Regional Anesthesia

Wound Infiltration

Arm Description

Ultrasound guided blocks

Surgeon-delivered wound infiltration

Outcomes

Primary Outcome Measures

Total amount of opioid medications administered
Postoperative opioid medication expressed in morphine equivalents per kilogram

Secondary Outcome Measures

Total amount of opioid medications administered
Postoperative opioid medication expressed in morphine equivalents per kilogram
Total amount of opioid medications administered
Postoperative opioid medication expressed in morphine equivalents per kilogram
Total amount of opioid medications administered
Postoperative opioid medication expressed in morphine equivalents per kilogram
Pain Intensity as measured by Face, Legs, Activity, Cry, Consolability (FLACC) Scale
Face, Legs, Activity, Cry, Consolability (FLACC) Scale, 0-10. 0 no pain, 10 worst possible pain
Pain Intensity as measured by Face, Legs, Activity, Cry, Consolability (FLACC) Scale
Face, Legs, Activity, Cry, Consolability (FLACC) Scale, 0-10. 0 no pain, 10 worst possible pain
Pain Intensity as measured by Face, Legs, Activity, Cry, Consolability (FLACC) Scale
Face, Legs, Activity, Cry, Consolability (FLACC) Scale, 0-10. 0 no pain, 10 worst possible pain
Pain Intensity as measured by Numeric Rating Scale
Visual Analog Scale and Numeric Rating Scale, 0-10. 0 no pain, 10 worst possible pain
Pain Intensity as measured by Numeric Rating Scale
Visual Analog Scale and Numeric Rating Scale, 0-10. 0 no pain, 10 worst possible pain
Pain Intensity as measured by Numeric Rating Scale
Visual Analog Scale and Numeric Rating Scale, 0-10. 0 no pain, 10 worst possible pain

Full Information

First Posted
January 9, 2023
Last Updated
March 29, 2023
Sponsor
Duke University
Collaborators
The Society of Pediatric Anesthesia
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1. Study Identification

Unique Protocol Identification Number
NCT05688670
Brief Title
Regional Anesthesia Following Pediatric Cardiac Surgery
Official Title
Pain Control With Regional Anesthesia Following Pediatric Cardiac Surgery: A Randomized Double-Blinded Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 29, 2023 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
March 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
The Society of Pediatric Anesthesia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate pain control following pediatric cardiac surgery with the use of local anesthesia via an ultrasound guided regional anesthetic technique compared with surgeon delivered wound infiltration.
Detailed Description
This is a single center, randomized, double blind investigation which will compare postoperative pain control indices, functional recovery metrics and patient/parental satisfaction for pediatric patients receiving an ultrasound guided regional anesthetic versus surgeon delivered wound infiltration in children undergoing primary atrial and ventricular septal defect repairs. Surgical and anesthesia care, with the exception of the technique of local anesthetic administration, are not altered for study purposes. Subjects are randomized 1:1 to either bilateral Pecto-Intercostal Fascial Block and unilateral Rectus Sheath Block or infiltration of the wound through the perioperative period. Both interventions will use an equal volume of Ropivacaine 0.2% based on weight. Exploratory data will be collected for up to 30 days postoperatively.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Septal Defect, Ventricular Septal Defect, Pain, Procedural
Keywords
Regional anesthesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Regional Anesthesia
Arm Type
Active Comparator
Arm Description
Ultrasound guided blocks
Arm Title
Wound Infiltration
Arm Type
Active Comparator
Arm Description
Surgeon-delivered wound infiltration
Intervention Type
Procedure
Intervention Name(s)
Regional Anesthesia
Intervention Description
Bilateral pecto-intercostal fascial plane block (PIFB) and unilateral rectus sheath block (RSB) with Ropivacaine 0.2%
Intervention Type
Procedure
Intervention Name(s)
Wound infiltration
Intervention Description
Surgeon-delivered wound infiltration with Ropivacaine 0.2%
Intervention Type
Drug
Intervention Name(s)
Ropivacaine 0.2% Injectable Solution
Intervention Description
Ropivacaine 1.5 mL/kg will be used for both interventions
Primary Outcome Measure Information:
Title
Total amount of opioid medications administered
Description
Postoperative opioid medication expressed in morphine equivalents per kilogram
Time Frame
Up to 12 hours after surgery
Secondary Outcome Measure Information:
Title
Total amount of opioid medications administered
Description
Postoperative opioid medication expressed in morphine equivalents per kilogram
Time Frame
12 to 24 hours after surgery
Title
Total amount of opioid medications administered
Description
Postoperative opioid medication expressed in morphine equivalents per kilogram
Time Frame
24 to 48 hours after surgery
Title
Total amount of opioid medications administered
Description
Postoperative opioid medication expressed in morphine equivalents per kilogram
Time Frame
Up to 48 hours after surgery
Title
Pain Intensity as measured by Face, Legs, Activity, Cry, Consolability (FLACC) Scale
Description
Face, Legs, Activity, Cry, Consolability (FLACC) Scale, 0-10. 0 no pain, 10 worst possible pain
Time Frame
within the first 12 hours after surgery
Title
Pain Intensity as measured by Face, Legs, Activity, Cry, Consolability (FLACC) Scale
Description
Face, Legs, Activity, Cry, Consolability (FLACC) Scale, 0-10. 0 no pain, 10 worst possible pain
Time Frame
12 to 24 hours after surgery
Title
Pain Intensity as measured by Face, Legs, Activity, Cry, Consolability (FLACC) Scale
Description
Face, Legs, Activity, Cry, Consolability (FLACC) Scale, 0-10. 0 no pain, 10 worst possible pain
Time Frame
24 to 48 hours after surgery
Title
Pain Intensity as measured by Numeric Rating Scale
Description
Visual Analog Scale and Numeric Rating Scale, 0-10. 0 no pain, 10 worst possible pain
Time Frame
within the first 12 hours after surgery
Title
Pain Intensity as measured by Numeric Rating Scale
Description
Visual Analog Scale and Numeric Rating Scale, 0-10. 0 no pain, 10 worst possible pain
Time Frame
12 to 24 hours after surgery
Title
Pain Intensity as measured by Numeric Rating Scale
Description
Visual Analog Scale and Numeric Rating Scale, 0-10. 0 no pain, 10 worst possible pain
Time Frame
24 to 48 hours after surgery

10. Eligibility

Sex
All
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Children less than 18 years old Presenting for primary atrial septal defect or ventricular septal defect repair Informed consent / assent provided Exclusion Criteria: Patients on opioid therapy at the time of surgery History of sternotomy Planned postoperative intubation Current diagnosis of a chronic pain syndrome.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julia Hoang
Phone
919.681.9786
Email
Julia.hoang@duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa M Einhorn, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julia Hoang
Email
Julia.hoang@duke.edu
First Name & Middle Initial & Last Name & Degree
Lisa M. Einhorn, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No

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Regional Anesthesia Following Pediatric Cardiac Surgery

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