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NCT02995291
Reversing the Effects of 0.5% Bupivacaine
Phase 4 trial testing OraVerse in Anesthesia, Local in 44 participants. Completed in 15 September 2019.
15 May 2019
Quick facts
| Lead sponsor | Dalhousie University |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 44 |
| Start date | 10 February 2017 |
| Primary completion | 15 May 2019 |
| Estimated completion | 15 September 2019 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- OraVerse — full drug profile →
- Saline Water (Control) — full drug profile →
Conditions studied
- Anesthesia, Local — all drugs for Anesthesia, Local →
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.
Verify or expand the search:
- PubMed search for NCT02995291
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Dalhousie University trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02995291 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Dalhousie University
- Last refreshed: 29 January 2020
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.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing