NCT05688670

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 18, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

March 29, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2025

Completed
7 months until next milestone

Results Posted

Study results publicly available

August 28, 2025

Completed
Last Updated

August 28, 2025

Status Verified

August 1, 2025

Enrollment Period

1.6 years

First QC Date

January 9, 2023

Results QC Date

August 8, 2025

Last Update Submit

August 26, 2025

Conditions

Atrial Septal DefectVentricular Septal DefectPain, Procedural

Keywords

Regional anesthesia

Outcome Measures

Primary Outcomes (1)

  • Total Amount of Opioid Medications Administered

    Postoperative opioid medication expressed in morphine equivalents per kilogram

    Up to 12 hours after surgery

Secondary Outcomes (3)

  • Total Amount of Opioid Medications Administered

    12-24 hours after surgery; 24-48 hours after surgery; 12-48 hours hours after surgery

  • Total Amount of Opioid Medications Administered

    Up to 48 hours after surgery

  • Postoperative Pain Intensity AUC

    48 hours

Study Arms (2)

Regional Anesthesia

ACTIVE COMPARATOR

Ultrasound guided blocks

Procedure: Regional AnesthesiaDrug: Ropivacaine 0.2% Injectable Solution

Wound Infiltration

ACTIVE COMPARATOR

Surgeon-delivered wound infiltration

Procedure: Wound infiltrationDrug: Ropivacaine 0.2% Injectable Solution

Interventions

Regional AnesthesiaPROCEDURE

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

Regional Anesthesia
Wound infiltrationPROCEDURE

Surgeon-delivered wound infiltration with Ropivacaine 0.2%

Wound Infiltration
Ropivacaine 0.2% Injectable SolutionDRUG

Ropivacaine 1.5 mL/kg will be used for both interventions

Regional AnesthesiaWound Infiltration

Eligibility Criteria

AgeUp to 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Heart Septal Defects, AtrialHeart Septal Defects, VentricularPain, Procedural

Interventions

Anesthesia, ConductionRopivacaine

Condition Hierarchy (Ancestors)

Heart Septal DefectsHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and AnalgesiaAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Results Point of Contact

Title
Lisa Einhorn, M.D.
Organization
Duke University Medical Center
lisa.einhorn@duke.edu
(919) 668-4000

Study Officials

  • Lisa M Einhorn, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2023

First Posted

January 18, 2023

Study Start

March 29, 2023

Primary Completion

October 18, 2024

Study Completion

January 22, 2025

Last Updated

August 28, 2025

Results First Posted

August 28, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)