Regional Anesthesia Following Pediatric Cardiac Surgery

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-29

Study Completion Date

2025-01-22

Brief Summary

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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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Detailed Description

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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

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Atrial Septal Defect Ventricular Septal Defect Pain, Procedural

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Regional Anesthesia

Ultrasound guided blocks

Group Type ACTIVE_COMPARATOR

Regional Anesthesia

Intervention Type PROCEDURE

Bilateral pecto-intercostal fascial plane block (PIFB) and unilateral rectus sheath block (RSB) with Ropivacaine 0.2%

Ropivacaine 0.2% Injectable Solution

Intervention Type DRUG

Ropivacaine 1.5 mL/kg will be used for both interventions

Wound Infiltration

Surgeon-delivered wound infiltration

Group Type ACTIVE_COMPARATOR

Wound infiltration

Intervention Type PROCEDURE

Surgeon-delivered wound infiltration with Ropivacaine 0.2%

Ropivacaine 0.2% Injectable Solution

Intervention Type DRUG

Ropivacaine 1.5 mL/kg will be used for both interventions

Interventions

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Regional Anesthesia

Bilateral pecto-intercostal fascial plane block (PIFB) and unilateral rectus sheath block (RSB) with Ropivacaine 0.2%

Intervention Type PROCEDURE

Wound infiltration

Surgeon-delivered wound infiltration with Ropivacaine 0.2%

Intervention Type PROCEDURE

Ropivacaine 0.2% Injectable Solution

Ropivacaine 1.5 mL/kg will be used for both interventions

Intervention Type DRUG

Eligibility Criteria

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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.

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes