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NCT05688670 Clinical Trial

Regional Anesthesia Following Pediatric Cardiac Surgery

Pain, Procedural Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05688670
Other study ID # PRO00111671
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date March 29, 2023
Est. completion date June 1, 2025

Study information
Verified date March 2024
Source Duke University
Contact Julia Hoang
Phone 919.681.9786
Email Julia.hoang@duke.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 42
Est. completion date June 1, 2025
Est. primary completion date March 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 17 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Regional Anesthesia
Bilateral pecto-intercostal fascial plane block (PIFB) and unilateral rectus sheath block (RSB) with Ropivacaine 0.2%
• 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

Locations
Country Name City State
United States Duke University Medical Center Durham North Carolina

Sponsors (2)
Lead Sponsor Collaborator
Duke University The Society of Pediatric Anesthesia

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Total amount of opioid medications administered Postoperative opioid medication expressed in morphine equivalents per kilogram Up to 12 hours after surgery
Secondary Total amount of opioid medications administered Postoperative opioid medication expressed in morphine equivalents per kilogram 12 to 24 hours after surgery
Secondary Total amount of opioid medications administered Postoperative opioid medication expressed in morphine equivalents per kilogram 24 to 48 hours after surgery
Secondary Total amount of opioid medications administered Postoperative opioid medication expressed in morphine equivalents per kilogram Up to 48 hours after surgery
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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