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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wound infiltration | Active Comparator | Standard intervention - surgical infiltration with local anesthetics |
|
| Truncal blocks | Experimental | Truncal block for anesthetics |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wound infiltration | Procedure | Surgical wound infiltration by proceduralist |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative and postoperative opioid consumption | Total intraoperative and postoperative opioid consumption of subjects | Up to Post-Op Day 10 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ali Shariat, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Morningside Hospital Center | New York | New York | 10025 | United States |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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The researcher assessing the subjects postoperatively will be different from the anesthesiologist that performs the interventions.
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| Truncal blocks |
| Procedure |
Truncal blocks provided by anesthesiology team for device placement |
|
| 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 |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |