Truncal Blocks Versus Wound Infiltration for SICD

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04974762
• Other study ID #: IRB-18-00379
• Status: Completed
• Phase: N/A
• Start date: January 23, 2019
• Est. completion date: February 18, 2022

Study information

• Verified date: August 2022
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 18, 2022
• Est. primary completion date: February 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients over 18 years of age

• Patients undergoing S-ICD placement

Exclusion Criteria:

• Allergy to amide local anesthetics

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• Wound infiltration
Surgical wound infiltration by proceduralist
• Truncal blocks
Truncal blocks provided by anesthesiology team for device placement

Locations

Country	Name	City	State
United States	Mount Sinai Morningside Hospital Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

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