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Regional Anesthesia Following Pediatric Cardiac Surgery

NCT05688670 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2025-08-28

Study results available
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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.

Conditions

  • Atrial Septal Defect
  • Ventricular Septal Defect
  • Pain, Procedural

Interventions

PROCEDURE

Regional Anesthesia

Bilateral pecto-intercostal fascial plane block (PIFB) and unilateral rectus sheath block (RSB) with Ropivacaine 0.2%

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

Sponsors & Collaborators

  • The Society of Pediatric Anesthesia

    collaborator UNKNOWN

  • Duke University

    lead OTHER

Principal Investigators

  • Lisa M Einhorn, MD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-29
Primary Completion
2024-10-18
Completion
2025-01-22
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05688670 on ClinicalTrials.gov