drugset / Trial / NCT06107660

Utility of Exparel Based ESP Blocks in Elective Posterior Spine Fusion

NCT06107660 ↗

Phase 4 Unknown 100 enrolled Hartford Hospital
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The goal of this clinical trial is to compare two different medications used to reduce pain during lower back fusion surgery. The main questions this study aims to answer are: 1. Can liposomal bupivacaine, when included in a regional anesthesia technique called the Erector Spinae Plane block (ESPB), reduce opioid use post-operatively compared to the standard medication typically used in an ESPB (bupivacaine with stabilizing agents)? 2. Do patients report lower pain and better satisfaction with their surgery when they receive liposomal bupivacaine in the ESPB compared to those that receive the standard medication? Participants will be randomized to into two groups one that receives liposomal bupivacaine and one group that receives bupivacaine with stabilizing agents. Other than the randomization all patients will follow current standard of care at our hospital, and will not be asked to complete any additional study forms in addition to forms currently asked of all patients as per standard of care.

Timeline

Start
2023-12
Primary completion
2025-06
Completion
2025-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bupivacaine Other / unclassified 40 ml Other
Comparator Bupivacaine Other / unclassified 60 ml Other
Comparator Bupivacaine Other / unclassified 266 mg Other

Indications

No indication recorded.