Intraoperative Pain, Postoperative Pain
Conditions
Keywords
Subcutaneous implantable cardioverter-defibrillators (S-ICD), Truncal blocks
Brief summary
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
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.
Interventions
PROCEDUREWound infiltration
Surgical wound infiltration by proceduralist
PROCEDURETruncal blocks
Truncal blocks provided by anesthesiology team for device placement
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
The researcher assessing the subjects postoperatively will be different from the anesthesiologist that performs the interventions.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients over 18 years of age * Patients undergoing S-ICD placement
Exclusion criteria
* Allergy to amide local anesthetics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative and postoperative opioid consumption | Up to Post-Op Day 10 | Total intraoperative and postoperative opioid consumption of subjects |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sedation (propofol) requirements intraoperatively | Day 1, Day of Surgery | Total propofol required by subjects intraoperatively |
| Number of participants with ICU stay | Up to Post-Op Day 10 | Need of intensive care unit (ICU) stay |
| Duration of ICU stay | Up to Post-Op Day 10 | Duration of intensive care unit (ICU) stay |
| Non-opioid analgesic consumption | Up to Post-Op Day 10 | Total intraoperative and postoperative non-opioid analgesic consumption of subjects |
| Total procedure time | Day 1 at Surgery | Total duration of procedure time measured in minutes |
| Length of stay | Day 1 at Surgery | Length of time in the postanesthesia care unit measured in minutes |
| Visual Analog Pain score | Up to Post-Op Day 10 | Visual Analog Pain Score (VAS) - total scale from 0-10, with higher score indicating more pain |
Countries
United States
Outcome results
None listed