Serratus Anterior Plane Block for Management of Post Thoracotomy Pain

Study Overview
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Brief Summary
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This is a single-center, randomized, prospective study evaluating the effect of serratus anterior plane block performed after induction of anesthesia, but before the start of surgery on postoperative opioid requirements. The hypothesis of the study is that serratus anterior plane blocks are relatively simple to perform, provide good postoperative analgesia, facilitate early tracheal extubation, and reduce the length of hospital stay after pediatric cardiac surgery through a thoracotomy.

Detailed Description
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This is a single-center, randomized, prospective study evaluating the effect of serratus anterior plane block performed after induction of anesthesia, but before the start of surgery on postoperative opioid requirements. There is already a postoperative protocol for the management of pain in the pediatric cardiac intensive care unit. This protocol will be maintained so all patients will be receiving clinically accepted and standard postoperative pain management. Routine preoperative evaluation will be performed to establish eligibility for study inclusion. All patients will receive anesthesia by a pediatric cardiac anesthesiologist according to the clinical protocol established for these patients. The serratus anterior plane block will be performed by a pediatric anesthesiologist on the acute pain service team who routinely perform pain blocks at this institution. Group 1 will receive an ultra-sound guided serratus anterior block after induction of general anesthesia. Group 2 will not receive a serratus anterior block. Postoperative pain will be managed by a pediatric cardiac intensivist according to a standard pain protocol.

Official Title
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Serratus Anterior Plane Block for Management of Post Thoracotomy Pain and Facilitation of Early Recovery After Pediatric Cardiac Surgery

Conditions
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Opioid Use, Post-thoracotomy Pain Syndrome, Local Anaesthetic Agent Overdose, Local Anesthetic Complication, Pain, Postoperative

Intervention / Treatment
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* Procedure: Serratus anterior block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 12 months of age or less Infants undergoing cardiac surgery through a thoracotomy incision Infants having surgery performed by a Pediatric Cardiac Surgeon at Riley Hospital Exclusion Criteria: Infants requiring sternotomy or emergency surgery Allergy to local anesthetics Neonates less that 37 weeks gestation Infants intubated prior to surgery Infection at the site of the Serratus Anterior Plane Block 6. Bleeding diathesis with increased risk of hematoma at the block site 7. Allergy to morphine 8. Active pulmonary infection

Ages Eligible for Study
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Minimum Age: 38 Weeks
Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1-Block Arm<br>Group1 will receive an ultra-sound guided serratus anterior block after induction of general anesthesia | Procedure: Serratus anterior block<br>* Serratus anterior block will be performed using an ultrasound guided transducer to inject 2mg/kg of 0.2% ropivacaine<br>|
| No Intervention: Group 2-No Block Arm<br>Group 2 will not receive a serratus block after induction of general anesthesia | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of Postoperative Narcotic Exposure | Total morphine equivalents in first 24 hours | From start of anesthesia to 24 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Mechanical Ventilation | Total Time in hours and minutes of endotracheal intubation from date and time of intubation to the date and time of extubation up to 100 days | From date and time of endotracheal intubation to the date and time of endotracheal extubation up to 100 days | 
| Length of Cardiovascular ICU stay | Duration of hospital stay in the Cardiovascular ICU in hours up to 100 days | From admission to the Cardiovascular ICU until discharge ready time from the Cardiovascular ICU up to 100 days | 
| Postoperative Pain Scores | Pain scores reported at arrival to ICU, and at 1, 2, 4, 6,8,10,12,and 24 hours | From arrival to ICU to 24 hours postoperatively | 
| Duration of Supplemental oxygen exposure | Total time of supplemental oxygen usage from date and time of endotracheal extubation and application of supplemental oxygen to date and time of supplemental oxygen discontinuation up to 100 days | From date and time arriving in the ICU to date and time of discharge from hospital up to 100 days | 
| Adverse events | Complications from the block, anesthesia or the surgery up to 72 hours post operatively | From block placement until 72 hours post operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post thoractomy pain, Fascial plane blocks, Early recovery after thoractomy, Serratus anterior fascial block