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Reversing the Effects of 0.5% Bupivacaine

NCT02995291 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2020-01-29

No results posted yet for this study

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).

Conditions

  • Anesthesia, Local

Interventions

DRUG

OraVerse

1.7ml OraVerse (0.4 mg phentolamine mesylate) will be injected once after the participants are found to be well anesthetized following an injection of 1.8ml Bupivacaine 0.5% (inferior alveolar nerve block). Oraverse will be injected at the same site Bupivacaine was injected.

DRUG

Saline Water (Control)

1.7ml saline water will be injected once after the participants are found to be well anesthetized following an injection of 1.8ml Bupivacaine 0.5% (inferior alveolar nerve block). The water will be injected at the same site Bupivacaine was injected.

Sponsors & Collaborators

  • Dalhousie University

    lead OTHER

Principal Investigators

  • Pierre-Luc Michaud, DMD, MSc, FRCDC · Dalhousie University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02995291 on ClinicalTrials.gov