Reversing the Effects of 0.5% Bupivacaine

NCT02995291 | Completed Phase 4

• 1 other identifier: 2016-4014
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Time to reversal of local anesthesia

  8 hours

Study Arms (2)

Control

PLACEBO COMPARATOR

1.7ml saline water

Drug: Saline Water (Control)

OraVerse

EXPERIMENTAL

1.7ml OraVerse

Drug: OraVerse

Interventions

OraVerse DRUG

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.

Also known as: phentolamine mesylate

OraVerse

Saline Water (Control) DRUG

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.

Also known as: Placebo

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• capable of providing informed consent

You may not qualify if:

• contra-indications for regular dental treatment
• medical history that contraindicates the use of epinephrine
• participant taken an opioid or an opioid like analgesic within 24 hours
• pregnant

Sponsors & Collaborators

• Dalhousie University: lead

Study Sites (1)

Dalhousie University Faculty of Dentistry

Halifax, Nova Scotia, B3H 4R2, Canada

Location

Related Links

• Dalhousie University Faculty of Dentistry Web Site

MeSH Terms

Interventions

Phentolamine; Saline Waters

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Environment; Ecological and Environmental Phenomena; Biological Phenomena

Study Officials

• Pierre-Luc Michaud, DMD, MSc, FRCDC

  Dalhousie University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 14, 2016
• First Posted: December 16, 2016
• Study Start: February 10, 2017
• Primary Completion: May 15, 2019
• Study Completion: September 15, 2019
• Last Updated: January 29, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)