NCT04974762

Truncal Blocks Versus Wound Infiltration for SICD

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intraoperative Pain
• Postoperative Pain

Interventions

Type	Name	Description
PROCEDURE	Wound infiltration	Surgical wound infiltration by proceduralist
PROCEDURE	Truncal blocks	Truncal blocks provided by anesthesiology team for device placement

Timeline

• Start date: 2019-01-23
• Primary completion: 2022-02-18
• Completion: 2022-02-18
• First posted: 2021-07-23
• Last updated: 2022-08-04

Locations

1 site across 1 country: United States