Regional Anesthesia Following Pediatric Cardiac Surgery

Phase 4

Completed

• Conditions: Atrial Septal Defect; Ventricular Septal Defect; Pain, Procedural
• Interventions: Procedure: Regional Anesthesia; Procedure: Wound infiltration; Drug: Ropivacaine 0.2% Injectable Solution

• Registration Number: NCT05688670
• Lead Sponsor: Duke University

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.

Study Timeline

• Study First Submitted: 2023-01-09
• Study First Submitted QC: 2023-01-09
• Study First Posted: 2023-01-18
• Study Start: 2023-03-29
• Primary Completion: 2024-10-18
• Study Completion: 2025-01-22
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Regional Anesthesia	Regional Anesthesia	Ultrasound guided blocks
Regional Anesthesia	Ropivacaine 0.2% Injectable Solution	Ultrasound guided blocks
Wound Infiltration	Wound infiltration	Surgeon-delivered wound infiltration
Wound Infiltration	Ropivacaine 0.2% Injectable Solution	Surgeon-delivered wound infiltration

Primary Outcome Measures

Name	Time	Method
Total amount of opioid medications administered	Up to 12 hours after surgery	Postoperative opioid medication expressed in morphine equivalents per kilogram

Secondary Outcome Measures

Name	Time	Method
Pain Intensity as measured by Face, Legs, Activity, Cry, Consolability (FLACC) Scale	24 to 48 hours after surgery	Face, Legs, Activity, Cry, Consolability (FLACC) Scale, 0-10. 0 no pain, 10 worst possible pain
Pain Intensity as measured by Numeric Rating Scale	24 to 48 hours after surgery	Visual Analog Scale and Numeric Rating Scale, 0-10. 0 no pain, 10 worst possible pain
Total amount of opioid medications administered	Up to 48 hours after surgery	Postoperative opioid medication expressed in morphine equivalents per kilogram

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States