Truncal Blocks Versus Wound Infiltration for SICD

Mount Sinai Health System

Status: Completed

Conditions: Postoperative Pain; Intraoperative Pain

Treatments: Procedure: Wound infiltration; Procedure: Truncal blocks

Study type: Interventional

Funder types: Other

Identifiers

NCT04974762

IRB-18-00379

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Allergy to amide local anesthetics

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Wound infiltration

Active Comparator group

Description:

Standard intervention - surgical infiltration with local anesthetics

Treatment:

Procedure: Wound infiltration

Truncal blocks

Experimental group

Description:

Truncal block for anesthetics

Treatment:

Procedure: Truncal blocks