drugset / Trial / NCT04751344

Liposomal Bupivacaine Versus Bupivacaine Plain for Operative Pain Management of Forefoot Surgery

NCT04751344 ↗

Phase 4 Unknown 100 enrolled Alexandra Black
RandomizedParallel-groupSingle-blindOther

Summary

Prospective, randomized, controlled single-blinded trial comparing liposomal bupivacaine with bupivacaine HCl for postoperative management. Upon completion of the forefoot procedure in the operative room the subject will be entered into the randomization system which will specify whether to inject 10cc (5mg/mL) of bupivacaine HCl or 8cc (13.3 mg/mL) liposomal bupivacaine, both considered routine care procedure. Thereafter, postoperative pain will be assessed and measured using a Visual Analog Scale (VAS) scoring scale post-operatively at 2 hours, 24 hours, 48 hours and 72 hours. In addition, the amount of oral morphine equivalents (OME) required postoperatively and time to first use of OME will be measured. Our hypothesis is that patients who received liposomal bupivacaine will have less post-operative pain and require less OMEs.

Timeline

Start
2020-06-16
Primary completion
2022-06
Completion
2022-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bupivacaine Other / unclassified 8 ml Intravenous
Comparator Bupivacaine Other / unclassified 10 ml Intravenous

Indications