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NCT02995291

Reversing the Effects of 0.5% Bupivacaine

Completed Phase 4 Last updated 29 January 2020
What this trial tests

Phase 4 trial testing OraVerse in Anesthesia, Local in 44 participants. Completed in 15 September 2019.

Timeline
10 February 2017
Primary endpoint
15 May 2019
15 September 2019

Quick facts

Lead sponsorDalhousie University
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment44
Start date10 February 2017
Primary completion15 May 2019
Estimated completion15 September 2019
Sites1 location across Canada

Drugs / interventions tested

Conditions studied

Sponsor

Dalhousie University

Who can join

18 and older, any sex, with Anesthesia, Local. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Anesthesia, Local

Currently open trials in the same condition.

Other Dalhousie University trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02995291.

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