ESP/PIF for Sternotomy
Running, not enrolling · Early Phase 1
Conditions studied: Cardiac Surgery, Sternotomy
In brief
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.
Key facts
- Study ID
- NCT04985500
- Run by
- Icahn School of Medicine at Mount Sinai
- People needed
- 225
- Starts
- 2021-07-09
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-07-01
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adults 18-85 years old
- Scheduled to undergo cardiac procedures involving sternotomy
- All genders
You may not qualify if…
- ASA class V
- Urgent or emergent surgery
- Contraindications to administration of local anesthesia (e.g. local anesthetic allergy)
- History of substance abuse or chronic opioid use
- Patient refusal or inability to consent
Where it is running
- Mount Sinai Morningside Hospital — New York, New York, United States
Full record on ClinicalTrials.gov
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