drugset / Trial / NCT03318757

Bupivacaine Liposomal Injectable Suspension, Pain and Narcotic Use After Elective Orthognathic Surgery

NCT03318757 ↗

Phase 4 Withdrawn Boston University
RandomizedParallel-groupSingle-blindTreatment

Summary

This research is being done to determine quantitative and qualitative differences in patients' post-operative pain levels following elective orthognathic surgery after the local administration of a liposomal bupivacaine injection. A primary objective is to determine whether using a liposomal bupivacaine injection placed locally at the conclusion of elective orthognathic surgery will decrease pain levels (as determined by VAS scores). A secondary objective is to examine whether using a long acting liposomal bupivacaine injection locally at the conclusion of elective orthognathic surgery leads to decreased use of narcotics post-operatively.

Timeline

Start
2020-09
Primary completion
2021-12
Completion
2021-12

Outcome

Outcome not reported

Stopped: “The research could not be conducted as it was denied by the IRB.”

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bupivacaine Other / unclassified 10 ml Other
Comparator Bupivacaine Other / unclassified 133 mg Other

Indications

No indication recorded.