Truncal Blocks Versus Wound Infiltration for SICD

NCT ID: NCT04974762

Last Updated: 2022-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-23
• Study Completion Date: 2022-02-18

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.

Conditions

Intraoperative Pain; Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Wound infiltration

Standard intervention - surgical infiltration with local anesthetics

Group Type: ACTIVE_COMPARATOR

Wound infiltration

Intervention Type: PROCEDURE

Surgical wound infiltration by proceduralist

Truncal blocks

Truncal block for anesthetics

Group Type: EXPERIMENTAL

Truncal blocks

Intervention Type: PROCEDURE

Truncal blocks provided by anesthesiology team for device placement

Interventions

Wound infiltration

Surgical wound infiltration by proceduralist

Intervention Type: PROCEDURE

Truncal blocks

Truncal blocks provided by anesthesiology team for device placement

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Allergy to amide local anesthetics

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Ali Nima Shariat

Assistant Professor, Anesthesiology, Perioperative & Pain Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ali Shariat, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Mount Sinai Morningside Hospital Center

New York, New York, United States

Countries

United States

Other Identifiers

IRB-18-00379

Identifier Type: -

Identifier Source: org_study_id