Duke University Medical Center
Durham, North Carolina, 27710, United States
NCT Number: NCT05688670
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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Notify MeUp to 17 year
All sexes
Interventional
Phase 4
Durham, North Carolina, 27710, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Bilateral pecto-intercostal fascial plane block (PIFB) and unilateral rectus sheath block (RSB) with Ropivacaine 0.2%
Surgeon-delivered wound infiltration with Ropivacaine 0.2%
Ropivacaine 1.5 mL/kg will be used for both interventions
Time frame: Up to 12 hours after surgery
Postoperative opioid medication expressed in morphine equivalents per kilogram
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
Time frame: Up to 48 hours after surgery
Postoperative opioid medication expressed in morphine equivalents per kilogram
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.
Duke University
Other
Pain Control With Regional Anesthesia Following Pediatric Cardiac Surgery: A Randomized Double-Blinded Pilot Study
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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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