Regional Anesthesia Following Pediatric Cardiac Surgery

Duke University

Status and phase: Completed; Phase 4

Conditions: Atrial Septal Defect; Ventricular Septal Defect; Pain, Procedural

Treatments: Procedure: Regional Anesthesia; Drug: Ropivacaine 0.2% Injectable Solution; Procedure: Wound infiltration

Study type: Interventional

Funder types: Other

Identifiers

NCT05688670

PRO00111671

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: Under 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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52 participants in 2 patient groups

Regional Anesthesia

Active Comparator group

Description:

Ultrasound guided blocks

Treatment:

Drug: Ropivacaine 0.2% Injectable Solution

Procedure: Regional Anesthesia

Wound Infiltration

Active Comparator group

Description:

Surgeon-delivered wound infiltration

Treatment:

Procedure: Wound infiltration

Drug: Ropivacaine 0.2% Injectable Solution