drugset / Trial / NCT02995291

Reversing the Effects of 0.5% Bupivacaine

NCT02995291

Phase 4 Completed 44 enrolled Dalhousie University
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Clinical trials have shown phentolamine mesylate (PM), brand name OraVerse, to be effective at reducing the amount of time to reversal of local anesthesia with different dental anesthetics. However, to date no study investigated the efficacy of phentolamine mesylate to reverse anesthesia induced with the use of Bupivacaine. The objective of the proposed research is to conduct a pilot-scale randomized clinical trial evaluating the difference in time required for the return of normal soft-tissue sensation and function in participants who have received 0.5% Bupivacaine HCl, 1:200,000 epinephrine, followed by an injection with either 1) OraVerse (phentolamine mesylate) or 2) sterile physiological water (control).

Timeline

Start
2017-02-10
Primary completion
2019-05-15
Completion
2019-09-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Phentolamine Small molecule 0.4 mg Other

Indications

No indication recorded.