Clinical trial NCT04974762: Truncal Blocks Versus Wound Infiltration for SICD
Official title: Comparing Truncal Blocks Versus Wound Infiltration for Subcutaneous Implantable Cardioverter Defibrillator Implantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intraoperative Pain
Postoperative Pain
Keywords: Subcutaneous implantable cardioverter-defibrillators (S-ICD)
Truncal blocks
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2021-07-23
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Patients over 18 years of age
* Patients undergoing S-ICD placement

Exclusion Criteria:

* Allergy to amide local anesthetics

Primary outcomes:
measure: Intraoperative and postoperative opioid consumption
timeFrame: Up to Post-Op Day 10
Secondary outcomes:
measure: Non-opioid analgesic consumption
timeFrame: Up to Post-Op Day 10
measure: Sedation (propofol) requirements intraoperatively
timeFrame: Day 1, Day of Surgery
measure: Number of participants with ICU stay
timeFrame: Up to Post-Op Day 10
measure: Duration of ICU stay
timeFrame: Up to Post-Op Day 10
measure: Visual Analog Pain score
timeFrame: Up to Post-Op Day 10
measure: Total procedure time
timeFrame: Day 1 at Surgery
measure: Length of stay
timeFrame: Day 1 at Surgery
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Morningside Hospital Center
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Ali Shariat, MD
role: PRINCIPAL_INVESTIGATOR
References: