drugset
drugset / Trial / NCT04985500

ESP/PIF for Sternotomy

NCT04985500 ↗

Phase 0 Active not recruiting 225 enrolled Icahn School of Medicine at Mount Sinai
RandomizedFactorialDouble-blindTreatment

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.

Timeline

Start
2021-07-09
Primary completion
2026-12-31
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Bupivacaine Other / unclassified 0.25 % Other
Subject Bupivacaine Other / unclassified 10 ml Other
Subject Bupivacaine Other / unclassified 20 ml Other

Indications

No indication recorded.