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NCT04985500 · ClinicalTrials.gov registry record · Early Phase 1
ESP/PIF for Sternotomy
A Early Phase 1 study of Cardiac Surgery and Sternotomy, sponsored by Icahn School of Medicine at Mount Sinai.
- Active
- Registry status
- Early Phase 1
- Development phase
- 225
- Enrollment target
- 1
- Study location
NCT04985500: Active Early Phase 1 study of Cardiac Surgery and Sternotomy, sponsored by Icahn School of Medicine at Mount Sinai.
NCT04985500 is a Early Phase 1 study of Cardiac Surgery and Sternotomy that is active but no longer recruiting, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 225 participants, below the 734-participant average among 19 other Cardiac Surgery trials with a reported enrollment target (69% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04985500, a Early Phase 1 study of Cardiac Surgery and Sternotomy, is active but no longer recruiting, sponsored by Icahn School of Medicine at Mount Sinai.
- ACTIVE NOT RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 225 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a randomized study. The purpose of this study is to evaluate the effect of post-surgical pain control of two types of peripheral nerve blocks, specifically erector spinal plane (ESP) block and pecto-intercostal fascial (PIF) plane block. 90 subjects, from 18-85 years of age, undergoing cardiac surgery with median sternal incision will be enrolled at Mount Sinai Morningside Hospital Center. Study participation will last from the time of pre-operative evaluation to 72 hours after surgery. Subjects will be randomly assigned to receive 1 of the 3 different regimens at the beginning of surgery. Opioid consumption and pain scores after surgery will be evaluated. Though unlikely, risks include systemic absorption of local anesthetic, which can result in both central nervous system and cardiac toxicity.
Primary Outcome
The amount of opioid consumption (in mg IV morphine equivalents) during the first 24 hours post-op in patients undergoing cardiac surgeries with median sternotomy.
Conditions Studied
Interventions
- DRUG Bupivacain
- PROCEDURE Ultrasound
- PROCEDURE ESP block
- PROCEDURE PIF block
Study Locations (1)
New York
- Mount Sinai Morningside Hospital - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 225 participants |
| Start Date | 2021-07-09 |
| Est. Completion | 2025-12-31 |
| Phase | Early Phase 1 |
What the registry record for NCT04985500 still lists
NCT04985500 is an interventional study that assigns participants to a tested intervention. The registered 225 participants enrollment target is mid-sized for trials with a published cap, below the 734-participant average among 19 other Cardiac Surgery trials with a reported enrollment target (69% lower).
The record links to 2 conditions, with Cardiac Surgery appearing as the primary indexed condition, and to 4 interventions - of which Bupivacain is the first listed.
NCT04985500 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT04985500 about?
NCT04985500 is a clinical study titled "ESP/PIF for Sternotomy". This is a randomized study. The purpose of this study is to evaluate the effect of post-surgical pain control of two types of peripheral nerve blocks, specifically erector spinal plane (ESP) block and pecto-intercostal fascial (PIF) plane block. 90 subjects, from 18-85 years of age, undergoing card...
What is the current status of trial NCT04985500?
This trial is currently active not recruiting. It is a Early Phase 1 study. The enrollment target is 225 participants. The study started on 2021-07-09. Estimated completion is 2025-12-31.
What conditions does trial NCT04985500 study?
This clinical trial studies the following conditions: Cardiac Surgery, Sternotomy.
What interventions are being tested in trial NCT04985500?
The interventions under investigation include: Bupivacain (DRUG), Ultrasound (PROCEDURE), ESP block (PROCEDURE), PIF block (PROCEDURE).
Who is sponsoring clinical trial NCT04985500?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04985500 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cardiac Surgery
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04985500's enrollment target sits among peer trials
225 7th of 19 higher than 13 of 19 other Cardiac Surgery trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cardiac Surgery trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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