Serratus Anterior Plane Block Combined With Transversus Thoracic Muscle Plane Block Versus Conventional Local Anesthetic Infiltration for SICD Implantation: A Randomized Controlled Trial

Study Overview
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Brief Summary
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This is a prospective randomized study. The aim is to investigate the efficacy of a combined SAPB with TTPB for perioperative pain control compared to the standard local anesthetic infiltration technique in adult patients undergoing SICD implantation. The hypothesis is that the combined plane block provides better pain control compared to the standard local infiltration technique.

Official Title
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Serratus Anterior Plane Block Combined With Transversus Thoracic Muscle Plane Block Versus Conventional Local Anesthetic Infiltration for SICD Implantation: A Randomized Controlled Trial

Conditions
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Serratus Anterior Plane Block, Transversus Thoracis Plane Block, Subcutaneous ICD

Intervention / Treatment
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* Procedure: Combined serratus anterior plane block and transversus thoracis plane block
* Procedure: Standard local infiltration technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is able to provide a written informed consent. Patient is scheduled to have an elective SICD implantation procedure. Patient has none of the exclusion criteria Exclusion Criteria: Patient is unable to provide a written informed consent. Patient is younger than 18 years old. Patients with prior thoracotomy or other thoracic surgery altering anatomy. Patients with neurological deficits. Patients with impaired coagulation (Platelet count < 50,000 cells/mcl and/or INR > 1.4). Patient on anticoagulation therapy. Patient's weight below 50 kg

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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 |
| --- | --- |
| Experimental: Combined serratus anterior plane block and transversus thoracis plane block<br>The study group will receive a combined plane block by a dedicated anesthesia team prior to their procedure. 20 mL of local anesthetic (0.25% bupivacaine) will be injected for the Serratus anterior plane block and another 20 mL of local anesthetic (0.25% bupivacaine) will be injected in transversus thoracis plane block | Procedure: Combined serratus anterior plane block and transversus thoracis plane block<br>* The study group will receive a combined plane block by a dedicated anesthesia team prior to their procedure. 20 mL of local anesthetic (0.25% bupivacaine) will be injected for the Serratus anterior plane block and another 20 mL of local anesthetic (0.25% bupivacaine) will be injected in transversus thoracis plane block<br>|
| Active Comparator: Stand local anesthetic infiltration<br>Local anesthetic infiltration of the incision sites will be performed by the cardiologist prior to, and as, necessary during the procedure. The amount of local anesthetic used will be determined intraoperatively by the cardiologist according to the patients' requirements. | Procedure: Standard local infiltration technique<br>* Local anesthetic infiltration of the incision sites will be performed by the cardiologist prior to, and as, necessary during the procedure. The amount of local anesthetic used will be determined intraoperatively by the cardiologist according to the patients' requirements.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain score measured | by Numerical Rating Scale pain (0-10), 0 is no pain, 10 is the worst | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative pain score measured | by Numerical Rating Scale pain | Intraoperative | 
| Intraoperative sedation score | Richmond Agitation Sedation Scale (RASS) (+4 to -5) +4 combative -5 unarousable | Intraoperative | 
| Total local anesthetic volume used | Total local anesthetic volume used | Intraoperative | 
| Procedure duration | Procedure duration | Intraoperative | 
| Intraoperative hemodynamics | Intraoperative hemodynamics | Intraoperative | 
| Time to 1st rescue pain medication | Time to 1st rescue pain medication after surgery | 1 day | 
| Postoperative opioid consumption | Amount of opioids consumed after surgery | 1 day | 
| Patient satisfaction | How much is the patient satisfied with the pain management in the perioperative period | 1 day | 
| Block related complications | Any complications that may happen from either blocks, e.g infection, bleeding | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Serratus anterior plane block, Transversus thoracis plane block, SICD