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OpenTrials
Completed

NCT Number: NCT05688670

Regional Anesthesia Following Pediatric Cardiac Surgery

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Regional Anesthesia

Procedure

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

Wound Infiltration

Procedure

Surgeon-delivered wound infiltration with Ropivacaine 0.2%

Ropivacaine 0.2% Injectable Solution

Drug

Ropivacaine 1.5 mL/kg will be used for both interventions

Primary outcomes

  1. Total Amount of Opioid Medications Administered

    Time frame: Up to 12 hours after surgery

    Postoperative opioid medication expressed in morphine equivalents per kilogram

Secondary outcomes

  1. Total Amount of Opioid Medications Administered

    Time frame: 12-24 hours after surgery; 24-48 hours after surgery; 12-48 hours hours after surgery

    Postoperative opioid medication expressed in morphine equivalents per kilogram

  2. Total Amount of Opioid Medications Administered

    Time frame: Up to 48 hours after surgery

    Postoperative opioid medication expressed in morphine equivalents per kilogram

  3. Postoperative Pain Intensity AUC

    Time frame: 48 hours

    Cumulative burden of pain over time was assessed using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale. Scores range from 0-10, with higher scores indicating greater pain.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • The Society of Pediatric Anesthesia

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jan 18, 2023
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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