Comparison of Post-operative Analgesia in Pediatric Superficial TTMPB

Study Overview
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Brief Summary
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When a patient is to undergo heart surgery with a sternotomy, a transthoracic block is performed. The thoracic block is an analgesic technique which consists of injecting anesthetic product into the nerves, in order to avoid significant pain. The common technique is to make injections in the sternum by the surgeon. A new, increasingly widespread method is performed by the anesthetist who performs the block under ultrasound. This research project aims to determine if performing this transthoracic block under ultrasound is more effective than injections performed by the surgeon without ultrasound.

Detailed Description
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Cardiac surgery, and more specifically associated sternotomy, leads to severe pain in the postoperative period. Adequate analgesia is therefore challenging, but of paramount importance to reduce associated side effects such as pulmonary hypertensive crisis, tachyarrhythmia, systemic hypertension, hypoxia, and increased morbidity and length of stay. Actual opioid crisis and risks associated with intravenous analgesics raises the question of having an alternative and better approach to relieve severe pain. Currently in the postoperative suites opiates are also used for sedative purposes. This strategy of sedation has to change. Recent advances in regional anaesthesia could be the answer. Thoracic epidural or paravertebral blocks provide effective analgesia for open cardiac surgery in paediatric patients. However, the major risk of epidural hematomas caused by heparinization, hemodynamic instability, technical difficulties and pneumothorax has limited the application of these two techniques in open cardiac surgery, and promoted the development of new approaches with safe, reliable, and cost-effective techniques, such as ultrasound-guided peripheral nerve blocks. This might be the most effective method for pain management in paediatric patients undergoing cardiac surgery according to recent studies. Superficial Thoracic Transversus Muscle Plane Block has been recently described and evaluated for pain management in adult cardiac surgery. It works through the blockade of multiple anterior branches of the intercostal nerves (Th2-6) in the internal mammary region. It has also been described in children in a few papers: Zhang and al. in a randomized controlled trial in 100 children, Abdelbaser and al. conducted a randomized double blind study including 80 children. In these studies, the injection of local anaesthetics was made between the intercostal and transversus thoracis muscles. But in very small children, the risk of pleura or internal mammary artery puncture associated with this injection is relatively important. Superficial TTMPB (located between the intercostal and pectoralis major muscles) seems to have the same analgesic potency without the aforementioned risks.That is to say that TTMPB is better than nothing but, to our knowledge, there is no study comparing infiltration by surgeon and TTMPB. The risks of the procedure are the same with all regional anaesthesia, which are vascular or nerves punction, hematoma and failure of anaesthesia. This study is set up to test the hypothesis that analgesia performed by TTMPB may have a better antalgic effect than blocks made by surgeons, in patients who undergo cardiac sternotomy. At first, the standard in CHUV was injections made by surgeon. Nowadays the decision of technic used is made with a discussion between anesthesist and surgeon during operative time. The investigators want to bring an evidence based decision with this study.

Official Title
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Comparison of Post-operative Analgesia in Pediatric Superficial TTMPB

Conditions
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Regional Anesthesia

Intervention / Treatment
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* Procedure: Transversus Thoracic Muscle Plane Block
* Procedure: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients undergoing sternotomy for a cardiac surgery in CHUV, which is an academic hospital in Switzerland. Participants fulfilling all of the following inclusion criteria are eligible for the study : Informed Consent as documented by signature. Age from 0 to 16 years old. Undergoing cardiac surgery with sternotomy in CHUV, Lausanne. Exclusion Criteria: • Patients older than 16 years. Pregnancy. Sternotomy for operation other than cardiac surgery. Contraindication to local anesthesic, e.g. known hypersensitivity or allergy to Bupivacaine. Infection at the site of injection. Not having consented for this procedure/ refusal of participation. Reoperation during the same hospitalisation.

Ages Eligible for Study
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Maximum Age: 16 Years

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control<br>Infiltration will be performed by surgeon at the site of sternotomy | Procedure: Control<br>* Infiltration by surgeon<br>|
| Active Comparator: With TTMPB<br>Regional anesthesia is performed with direct view of the nerves and vascular position | Procedure: Transversus Thoracic Muscle Plane Block<br>* The transversus thoracic muscle plane block It is most commonly performed following cardiothoracic surgeries (or any surgeries requiring sternotomy) to provide analgesia to the anterior chest wall. he TTMPB, and thoracic fascial plane blocks, are increasingly being employed as part of enhanced recovery after surgery (ERAS) protocols for cardiothoracic procedures. They have been shown to significantly reduce both the time to extubation and the incidence of acute and chronic perioperative pain<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioids dose | Opioids dose administered for analgesia in mg and divided by patient weight in kg | Day 0, Hour 24 post-operative. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioids dose | Opioids dose administered for analgesia in mg and divided by patient weight in kg | Day 0 at Hour 4, 12 and Day 1 post-operative | 
| Time to extubation | Time to extubation in minutes | From the time of arrival in the Intensive Care Unit until the time of extubation assessed up to 3 months | 
| Dose of catecholamine (noradrenaline) used | Total dose per kg infused | At Day 0 Hour 4, 12, 24 and Day 1 post-operative | 
| Length of stay in ICU before discharge | Length of stay in ICU before discharge in days | From the time of arrival in the Intensive Care Unit until discharge assessed up to 3 months | 
| Adverse Event | Analysis of adverse events and adverse events of special interest (complications) such as hematomas, arterial puncture, fail of the block, pneumothorax. | Day 1 post operatively | 
| FLACC pain scale (Face, Legs, Activity, Cry, Consolability) | Postoperative pain evaluated by the Flacc pain scale, From 0 to 10 were 10 is the worst pain experimented by the patient and 0 is the normal state. | at Day 0 at Hours 4, 12 and 24 post-operative; | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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regional anesthesia, pediatric, cardiac