An interventional study of Wound infiltration and Truncal blocks in Intraoperative Pain and Postoperative Pain, sponsored by Icahn School of Medicine at Mount Sinai. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-04.
Sponsored by Icahn School of Medicine at Mount Sinai · Not applicable, Interventional, and Treatment
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.
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.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 24 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Icahn School of Medicine at Mount Sinai is the lead sponsor of 764 studies on the registry; 181 are open to participants now.
Of its 121 completed or terminated interventional studies of FDA-regulated products, 82 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Standard intervention - surgical infiltration with local anesthetics
Procedure: Wound infiltration
Truncal block for anesthetics
Procedure: Truncal blocks
Surgical wound infiltration by proceduralist
Truncal blocks provided by anesthesiology team for device placement
Intraoperative and postoperative opioid consumption
Total intraoperative and postoperative opioid consumption of subjects
Time frame: Up to Post-Op Day 10
Non-opioid analgesic consumption
Total intraoperative and postoperative non-opioid analgesic consumption of subjects
Time frame: Up to Post-Op Day 10
Sedation (propofol) requirements intraoperatively
Total propofol required by subjects intraoperatively
Time frame: Day 1, Day of Surgery
Number of participants with ICU stay
Need of intensive care unit (ICU) stay
Time frame: Up to Post-Op Day 10
Duration of ICU stay
Duration of intensive care unit (ICU) stay
Time frame: Up to Post-Op Day 10
Visual Analog Pain score
Visual Analog Pain Score (VAS) - total scale from 0-10, with higher score indicating more pain
Time frame: Up to Post-Op Day 10
Total procedure time
Total duration of procedure time measured in minutes
Time frame: Day 1 at Surgery
Length of stay
Length of time in the postanesthesia care unit measured in minutes
Time frame: Day 1 at Surgery
Plan to share: No — Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Icahn School of Medicine at Mount Sinai