Truncal Blocks Versus Wound Infiltration for SICD

Not Applicable

Completed

• Conditions: Postoperative Pain; Intraoperative Pain
• Interventions: Procedure: Truncal blocks; Procedure: Wound infiltration

• Registration Number: NCT04974762
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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.

Study Timeline

• Study Start: 2019-01-23
• Study First Submitted: 2021-07-08
• Study First Submitted QC: 2021-07-22
• Study First Posted: 2021-07-23
• Primary Completion: 2022-02-18
• Study Completion: 2022-02-18
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-02
• Last Update Posted: 2022-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

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

Exclusion Criteria

• Allergy to amide local anesthetics

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Truncal blocks	Truncal blocks	Truncal block for anesthetics
Wound infiltration	Wound infiltration	Standard intervention - surgical infiltration with local anesthetics

Primary Outcome Measures

Name	Time	Method
Intraoperative and postoperative opioid consumption	Up to Post-Op Day 10	Total intraoperative and postoperative opioid consumption of subjects

Secondary Outcome Measures

Name	Time	Method
Length of stay	Day 1 at Surgery	Length of time in the postanesthesia care unit measured in minutes
Non-opioid analgesic consumption	Up to Post-Op Day 10	Total intraoperative and postoperative non-opioid analgesic consumption of subjects
Sedation (propofol) requirements intraoperatively	Day 1, Day of Surgery	Total propofol required by subjects intraoperatively
Number of participants with ICU stay	Up to Post-Op Day 10	Need of intensive care unit (ICU) stay
Duration of ICU stay	Up to Post-Op Day 10	Duration of intensive care unit (ICU) stay
Visual Analog Pain score	Up to Post-Op Day 10	Visual Analog Pain Score (VAS) - total scale from 0-10, with higher score indicating more pain
Total procedure time	Day 1 at Surgery	Total duration of procedure time measured in minutes

Trial Locations

Locations (1)

Mount Sinai Morningside Hospital Center; 🇺🇸 New York, New York, United States