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Completed

NCT Number: NCT04974762

Truncal Blocks Versus Wound Infiltration for SICD

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai Morningside Hospital Center

New York, 10025, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Allergy to amide local anesthetics

Treatment and study plan

Wound Infiltration

Procedure

Surgical wound infiltration by proceduralist

Truncal blocks

Procedure

Truncal blocks provided by anesthesiology team for device placement

Primary outcomes

  1. Intraoperative and postoperative opioid consumption

    Time frame: Up to Post-Op Day 10

    Total intraoperative and postoperative opioid consumption of subjects

Secondary outcomes

  1. Non-opioid analgesic consumption

    Time frame: Up to Post-Op Day 10

    Total intraoperative and postoperative non-opioid analgesic consumption of subjects

  2. Sedation (propofol) requirements intraoperatively

    Time frame: Day 1, Day of Surgery

    Total propofol required by subjects intraoperatively

  3. Number of participants with ICU stay

    Time frame: Up to Post-Op Day 10

    Need of intensive care unit (ICU) stay

  4. Duration of ICU stay

    Time frame: Up to Post-Op Day 10

    Duration of intensive care unit (ICU) stay

  5. Visual Analog Pain score

    Time frame: Up to Post-Op Day 10

    Visual Analog Pain Score (VAS) - total scale from 0-10, with higher score indicating more pain

  6. Total procedure time

    Time frame: Day 1 at Surgery

    Total duration of procedure time measured in minutes

  7. Length of stay

    Time frame: Day 1 at Surgery

    Length of time in the postanesthesia care unit measured in minutes

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jul 23, 2021
Registry last updated
Aug 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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