Trials / Completed
CompletedNCT05688670
Regional Anesthesia Following Pediatric Cardiac Surgery
Pain Control With Regional Anesthesia Following Pediatric Cardiac Surgery: A Randomized Double-Blinded Pilot Study
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 52 (actual)
- Sponsor
- Duke University · Academic / Other
- Sex
- All
- Age
- 17 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2023-03-29
- Primary completion
- 2024-10-18
- Completion
- 2025-01-22
- First posted
- 2023-01-18
- Last updated
- 2025-08-28
- Results posted
- 2025-08-28
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05688670. Inclusion in this directory is not an endorsement.