Clinical trial NCT05688670: Regional Anesthesia Following Pediatric Cardiac Surgery
Official title: Pain Control With Regional Anesthesia Following Pediatric Cardiac Surgery: A Randomized Double-Blinded Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atrial Septal Defect
Ventricular Septal Defect
Pain, Procedural
Keywords: Regional anesthesia
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: The Society of Pediatric Anesthesia
First posted: 2023-01-18
Enrollment: 52
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Total amount of opioid medications administered
timeFrame: Up to 12 hours after surgery
Secondary outcomes:
measure: Total amount of opioid medications administered
timeFrame: 12 to 24 hours after surgery
measure: Total amount of opioid medications administered
timeFrame: 24 to 48 hours after surgery
measure: Total amount of opioid medications administered
timeFrame: Up to 48 hours after surgery
measure: Pain Intensity as measured by Face, Legs, Activity, Cry, Consolability (FLACC) Scale
timeFrame: within the first 12 hours after surgery
measure: Pain Intensity as measured by Face, Legs, Activity, Cry, Consolability (FLACC) Scale
timeFrame: 12 to 24 hours after surgery
measure: Pain Intensity as measured by Face, Legs, Activity, Cry, Consolability (FLACC) Scale
timeFrame: 24 to 48 hours after surgery
measure: Pain Intensity as measured by Numeric Rating Scale
timeFrame: within the first 12 hours after surgery
measure: Pain Intensity as measured by Numeric Rating Scale
timeFrame: 12 to 24 hours after surgery
measure: Pain Intensity as measured by Numeric Rating Scale
timeFrame: 24 to 48 hours after surgery
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Lisa M Einhorn, MD
role: PRINCIPAL_INVESTIGATOR
References: