drugset / Trial / NCT04928339

Pecto-Intercostal Fascial Plane Block Study

NCT04928339 ↗

Phase 4 Completed 100 enrolled University of Wisconsin, Madison
RandomizedParallel-groupDouble-blindSupportive care

Summary

This study is being done to see if bilateral pecto-intercostal fascial plane blocks (PIFB) with a mixture of liposomal and standard bupivacaine decrease pain and opioid requirements in patients undergoing cardiac surgery via median sternotomy compared to controls (sham blocks with saline). 100 participants will be recruited and can expect to be on study for 100 days.

Timeline

Start
2022-03-28
Primary completion
2023-09-03
Completion
2023-11-30

Outcome

Missed primary endpoint

paper Total opioid consumption in the first 72 hours was not significantly different between groups (SPIP intervention: 165 (IQR 103-284) MME vs saline placebo: 205 (IQR 145-282) MME, p=0.30). PMID 40850695 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Bupivacaine Other / unclassified 0.25 % Other
Subject Bupivacaine Other / unclassified 10 ml Other
Subject Bupivacaine Other / unclassified 15 ml Other
Subject Bupivacaine Other / unclassified 133 mg Other