drugset / Trial / NCT04928339
Pecto-Intercostal Fascial Plane Block Study
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |