Truncal Blocks Versus Wound Infiltration for SICD

Study Overview
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Brief Summary
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This is a single-center, randomized and prospective trial of all patients undergoing S-ICD implantation. Subjects will only be eligible for this study if they are ≥ 18 years of age and eligible to undergo S-ICD implant at Mount Sinai Morningside Hospital. They will be randomized to receive either surgical infiltration of local anesthetic or truncal blocks. Intraoperative and postoperative data will be collected including total opioid use, pain scores postprocedure, total postoperative narcotic need and length of stay.

Detailed Description
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This is a single-center, randomized and prospective trial of all patients undergoing S-ICD implantation. Subjects will only be eligible for this study if they are ≥ 18 years of age and eligible to undergo S-ICD implant at Mount Sinai Morningside Hospital. They will be randomized to receive either surgical infiltration of local anesthetic or truncal blocks. Intraoperative and postoperative data will be collected including total opioid use, pain scores postprocedure, total postoperative narcotic need and length of stay. The procedures involved for the study are the placement of the described truncal blocks or wound infiltration. Data to be collected are patient demographics, history of present illness, past medical history, and pain management techniques required (i.e non-narcotics and narcotics use). In addition, age, race, gender and BMI will also be collected. Intraoperative analgesia requirements, postoperative analgesia requirements, duration of procedure and length of stay will also be collected.

Official Title
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Comparing Truncal Blocks Versus Wound Infiltration for Subcutaneous Implantable Cardioverter Defibrillator Implantation

Conditions
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Intraoperative Pain, Postoperative Pain

Intervention / Treatment
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* Procedure: Wound infiltration
* Procedure: Truncal blocks


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients over 18 years of age Patients undergoing S-ICD placement Exclusion Criteria: Allergy to amide local anesthetics

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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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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Wound infiltration<br>Standard intervention - surgical infiltration with local anesthetics | Procedure: Wound infiltration<br>* Surgical wound infiltration by proceduralist<br>|
| Experimental: Truncal blocks<br>Truncal block for anesthetics | Procedure: Truncal blocks<br>* Truncal blocks provided by anesthesiology team for device placement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative and postoperative opioid consumption | Total intraoperative and postoperative opioid consumption of subjects | Up to Post-Op Day 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-opioid analgesic consumption | Total intraoperative and postoperative non-opioid analgesic consumption of subjects | Up to Post-Op Day 10 | 
| Sedation (propofol) requirements intraoperatively | Total propofol required by subjects intraoperatively | Day 1, Day of Surgery | 
| Number of participants with ICU stay | Need of intensive care unit (ICU) stay | Up to Post-Op Day 10 | 
| Duration of ICU stay | Duration of intensive care unit (ICU) stay | Up to Post-Op Day 10 | 
| Visual Analog Pain score | Visual Analog Pain Score (VAS) - total scale from 0-10, with higher score indicating more pain | Up to Post-Op Day 10 | 
| Total procedure time | Total duration of procedure time measured in minutes | Day 1 at Surgery | 
| Length of stay | Length of time in the postanesthesia care unit measured in minutes | Day 1 at Surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Subcutaneous implantable cardioverter-defibrillators (S-ICD), Truncal blocks