Regional Anesthesia Following Pediatric Cardiac Surgery

Pain Control With Regional Anesthesia Following Pediatric Cardiac Surgery: A Randomized Double-Blinded Pilot Study

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Septal Defect; Pain, Procedural; Ventricular Septal Defect
• Intervention / Treatment: Procedure: Regional Anesthesia; Procedure: Wound infiltration; Drug: Ropivacaine 0.2% Injectable Solution

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.

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Julia Hoang; Phone Number: 919.681.9786; Email: Julia.hoang@duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke University Medical Center
      • Contact: Julia Hoang; Email: Julia.hoang@duke.edu
      • Principal Investigator: Lisa M. Einhorn, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 17 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Children less than 18 years old
2. Presenting for primary atrial septal defect or ventricular septal defect repair
3. Informed consent / assent provided

Exclusion Criteria:

1. Patients on opioid therapy at the time of surgery
2. History of sternotomy
3. Planned postoperative intubation
4. Current diagnosis of a chronic pain syndrome.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Regional Anesthesia; Ultrasound guided blocks	Procedure: Regional Anesthesia; Bilateral pecto-intercostal fascial plane block (PIFB) and unilateral rectus sheath block (RSB) with Ropivacaine 0.2%; Drug: Ropivacaine 0.2% Injectable Solution; Ropivacaine 1.5 mL/kg will be used for both interventions
Active Comparator: Wound Infiltration; Surgeon-delivered wound infiltration	Procedure: Wound infiltration; Surgeon-delivered wound infiltration with Ropivacaine 0.2%; Drug: Ropivacaine 0.2% Injectable Solution; Ropivacaine 1.5 mL/kg will be used for both interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total amount of opioid medications administered	Postoperative opioid medication expressed in morphine equivalents per kilogram	Up to 12 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total amount of opioid medications administered	Postoperative opioid medication expressed in morphine equivalents per kilogram	12 to 24 hours after surgery
Total amount of opioid medications administered	Postoperative opioid medication expressed in morphine equivalents per kilogram	24 to 48 hours after surgery
Total amount of opioid medications administered	Postoperative opioid medication expressed in morphine equivalents per kilogram	Up to 48 hours after surgery
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	within the first 12 hours after surgery
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	12 to 24 hours after surgery
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	24 to 48 hours after surgery
Pain Intensity as measured by Numeric Rating Scale	Visual Analog Scale and Numeric Rating Scale, 0-10. 0 no pain, 10 worst possible pain	within the first 12 hours after surgery
Pain Intensity as measured by Numeric Rating Scale	Visual Analog Scale and Numeric Rating Scale, 0-10. 0 no pain, 10 worst possible pain	12 to 24 hours after surgery
Pain Intensity as measured by Numeric Rating Scale	Visual Analog Scale and Numeric Rating Scale, 0-10. 0 no pain, 10 worst possible pain	24 to 48 hours after surgery

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: The Society of Pediatric Anesthesia
• Investigators: Principal Investigator: Lisa M Einhorn, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2023
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: January 9, 2023
• First Submitted That Met QC Criteria: January 9, 2023
• First Posted (Actual): January 18, 2023

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Regional anesthesia
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pain; Neurologic Manifestations; Congenital Abnormalities; Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Septal Defects; Heart Septal Defects, Atrial; Heart Septal Defects, Ventricular; Pain, Procedural; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: PRO00111671

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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