Truncal Blocks Versus Wound Infiltration for SICD

NCT04974762 | Completed

• 1 other identifier: IRB-18-00379
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Intraoperative Pain; Postoperative Pain

Keywords

Subcutaneous implantable cardioverter-defibrillators (S-ICD); Truncal blocks

Outcome Measures

Primary Outcomes (1)

• Intraoperative and postoperative opioid consumption

  Total intraoperative and postoperative opioid consumption of subjects

  Up to Post-Op Day 10

Secondary Outcomes (7)

• Non-opioid analgesic consumption

  Up to Post-Op Day 10

• Sedation (propofol) requirements intraoperatively

  Day 1, Day of Surgery

• Number of participants with ICU stay

  Up to Post-Op Day 10

• Duration of ICU stay

  Up to Post-Op Day 10

• Visual Analog Pain score

  Up to Post-Op Day 10

Study Arms (2)

Wound infiltration

ACTIVE COMPARATOR

Standard intervention - surgical infiltration with local anesthetics

Procedure: Wound infiltration

Truncal blocks

EXPERIMENTAL

Truncal block for anesthetics

Procedure: Truncal blocks

Interventions

Wound infiltration PROCEDURE

Surgical wound infiltration by proceduralist

Wound infiltration

Truncal blocks PROCEDURE

Truncal blocks provided by anesthesiology team for device placement

Truncal blocks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Allergy to amide local anesthetics

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai Morningside Hospital Center

New York, New York, 10025, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Ali Shariat, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The researcher assessing the subjects postoperatively will be different from the anesthesiologist that performs the interventions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Anesthesiology, Perioperative & Pain Medicine

Study Record Dates

• First Submitted: July 8, 2021
• First Posted: July 23, 2021
• Study Start: January 23, 2019
• Primary Completion: February 18, 2022
• Study Completion: February 18, 2022
• Last Updated: August 4, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)