Regional Anesthesia Following Pediatric Cardiac Surgery

• Sponsor: Duke University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05688670
• Collaborator: The Society of Pediatric Anesthesia (Other)
• Enrollment: 42
• Arms: 2
• Anticipated Duration (Months): 24

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Septal Defect; Ventricular Septal Defect; Pain, Procedural	Procedure: Regional Anesthesia; Procedure: Wound infiltration	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Pain Control With Regional Anesthesia Following Pediatric Cardiac Surgery: A Randomized Double-Blinded Pilot Study
• Anticipated Study Start Date: Mar 1, 2023
• Anticipated Primary Completion Date: Mar 1, 2024
• Anticipated Study Completion Date: Mar 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Regional Anesthesia Ultrasound guided blocks	Procedure: Regional Anesthesia; Bilateral pecto-intercostal fascial plane block (PIFB) and unilateral rectus sheath block (RSB) with Ropivacaine 0.2%
Active Comparator: Wound Infiltration Surgeon-delivered wound infiltration	Procedure: Wound infiltration; Surgeon-delivered wound infiltration with Ropivacaine 0.2%

Outcome Measures

Primary Outcome Measures

1. Total amount of opioid medications administered [Up to 12 hours after surgery]

   Postoperative opioid medication expressed in morphine equivalents per kilogram

Secondary Outcome Measures

1. Total amount of opioid medications administered [12 to 24 hours after surgery]

   Postoperative opioid medication expressed in morphine equivalents per kilogram

2. Total amount of opioid medications administered [24 to 48 hours after surgery]

   Postoperative opioid medication expressed in morphine equivalents per kilogram

3. Total amount of opioid medications administered [Up to 48 hours after surgery]

   Postoperative opioid medication expressed in morphine equivalents per kilogram

4. Pain Intensity as measured by Face, Legs, Activity, Cry, Consolability (FLACC) Scale [within the first 12 hours after surgery]

   Face, Legs, Activity, Cry, Consolability (FLACC) Scale, 0-10. 0 no pain, 10 worst possible pain

5. Pain Intensity as measured by Face, Legs, Activity, Cry, Consolability (FLACC) Scale [12 to 24 hours after surgery]

   Face, Legs, Activity, Cry, Consolability (FLACC) Scale, 0-10. 0 no pain, 10 worst possible pain

6. Pain Intensity as measured by Face, Legs, Activity, Cry, Consolability (FLACC) Scale [24 to 48 hours after surgery]

   Face, Legs, Activity, Cry, Consolability (FLACC) Scale, 0-10. 0 no pain, 10 worst possible pain

7. Pain Intensity as measured by Numeric Rating Scale [within the first 12 hours after surgery]

   Visual Analog Scale and Numeric Rating Scale, 0-10. 0 no pain, 10 worst possible pain

8. Pain Intensity as measured by Numeric Rating Scale [12 to 24 hours after surgery]

   Visual Analog Scale and Numeric Rating Scale, 0-10. 0 no pain, 10 worst possible pain

9. Pain Intensity as measured by Numeric Rating Scale [24 to 48 hours after surgery]

   Visual Analog Scale and Numeric Rating Scale, 0-10. 0 no pain, 10 worst possible pain

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Duke University
• The Society of Pediatric Anesthesia

Investigators

• Principal Investigator: Lisa M Einhorn, MD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT05688670
• Other Study ID Numbers: PRO00111671
• First Posted: Jan 18, 2023
• Last Update Posted: Jan 18, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Duke University: Regional anesthesia
• Additional relevant MeSH terms: Heart Septal Defects; Heart Septal Defects, Ventricular; Heart Septal Defects, Atrial; Pain, Procedural; Anesthetics

Study Results

No Results Posted as of Jan 18, 2023