Truncal Blocks Versus Wound Infiltration for SICD

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Intraoperative Pain
• Intervention / Treatment: Procedure: Wound infiltration; Procedure: Truncal blocks

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10025
      • Mount Sinai Morningside Hospital Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Allergy to amide local anesthetics

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Wound infiltration; Standard intervention - surgical infiltration with local anesthetics	Procedure: Wound infiltration; Surgical wound infiltration by proceduralist
Experimental: Truncal blocks; Truncal block for anesthetics	Procedure: Truncal blocks; Truncal blocks provided by anesthesiology team for device placement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative and postoperative opioid consumption	Total intraoperative and postoperative opioid consumption of subjects	Up to Post-Op Day 10

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Ali Shariat, MD, Icahn School Of Medicine At Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2019
• Primary Completion (Actual): February 18, 2022
• Study Completion (Actual): February 18, 2022

Study Registration Dates

• First Submitted: July 8, 2021
• First Submitted That Met QC Criteria: July 22, 2021
• First Posted (Actual): July 23, 2021

Study Record Updates

• Last Update Posted (Actual): August 4, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Subcutaneous implantable cardioverter-defibrillators (S-ICD); Truncal blocks
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: IRB-18-00379

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No