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Truncal Blocks Versus Wound Infiltration for SICD

Primary Purpose

Intraoperative Pain, Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Wound infiltration
Truncal blocks
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intraoperative Pain focused on measuring Subcutaneous implantable cardioverter-defibrillators (S-ICD), Truncal blocks

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Allergy to amide local anesthetics

Sites / Locations

  • Mount Sinai Morningside Hospital Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Wound infiltration

Truncal blocks

Arm Description

Standard intervention - surgical infiltration with local anesthetics

Truncal block for anesthetics

Outcomes

Primary Outcome Measures

Intraoperative and postoperative opioid consumption
Total intraoperative and postoperative opioid consumption of subjects

Secondary Outcome Measures

Non-opioid analgesic consumption
Total intraoperative and postoperative non-opioid analgesic consumption of subjects
Sedation (propofol) requirements intraoperatively
Total propofol required by subjects intraoperatively
Number of participants with ICU stay
Need of intensive care unit (ICU) stay
Duration of ICU stay
Duration of intensive care unit (ICU) stay
Visual Analog Pain score
Visual Analog Pain Score (VAS) - total scale from 0-10, with higher score indicating more pain
Total procedure time
Total duration of procedure time measured in minutes
Length of stay
Length of time in the postanesthesia care unit measured in minutes

Full Information

First Posted
July 8, 2021
Last Updated
August 2, 2022
Sponsor
Icahn School of Medicine at Mount Sinai
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1. Study Identification

Unique Protocol Identification Number
NCT04974762
Brief Title
Truncal Blocks Versus Wound Infiltration for SICD
Official Title
Comparing Truncal Blocks Versus Wound Infiltration for Subcutaneous Implantable Cardioverter Defibrillator Implantation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
January 23, 2019 (Actual)
Primary Completion Date
February 18, 2022 (Actual)
Study Completion Date
February 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraoperative Pain, Postoperative Pain
Keywords
Subcutaneous implantable cardioverter-defibrillators (S-ICD), Truncal blocks

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
The researcher assessing the subjects postoperatively will be different from the anesthesiologist that performs the interventions.
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Wound infiltration
Arm Type
Active Comparator
Arm Description
Standard intervention - surgical infiltration with local anesthetics
Arm Title
Truncal blocks
Arm Type
Experimental
Arm Description
Truncal block for anesthetics
Intervention Type
Procedure
Intervention Name(s)
Wound infiltration
Intervention Description
Surgical wound infiltration by proceduralist
Intervention Type
Procedure
Intervention Name(s)
Truncal blocks
Intervention Description
Truncal blocks provided by anesthesiology team for device placement
Primary Outcome Measure Information:
Title
Intraoperative and postoperative opioid consumption
Description
Total intraoperative and postoperative opioid consumption of subjects
Time Frame
Up to Post-Op Day 10
Secondary Outcome Measure Information:
Title
Non-opioid analgesic consumption
Description
Total intraoperative and postoperative non-opioid analgesic consumption of subjects
Time Frame
Up to Post-Op Day 10
Title
Sedation (propofol) requirements intraoperatively
Description
Total propofol required by subjects intraoperatively
Time Frame
Day 1, Day of Surgery
Title
Number of participants with ICU stay
Description
Need of intensive care unit (ICU) stay
Time Frame
Up to Post-Op Day 10
Title
Duration of ICU stay
Description
Duration of intensive care unit (ICU) stay
Time Frame
Up to Post-Op Day 10
Title
Visual Analog Pain score
Description
Visual Analog Pain Score (VAS) - total scale from 0-10, with higher score indicating more pain
Time Frame
Up to Post-Op Day 10
Title
Total procedure time
Description
Total duration of procedure time measured in minutes
Time Frame
Day 1 at Surgery
Title
Length of stay
Description
Length of time in the postanesthesia care unit measured in minutes
Time Frame
Day 1 at Surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients over 18 years of age Patients undergoing S-ICD placement Exclusion Criteria: Allergy to amide local anesthetics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Shariat, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Morningside Hospital Center
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

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Truncal Blocks Versus Wound Infiltration for SICD

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