Anesthesia, LocalPhase 4NCT02995291
Reversing the Effects of 0.5% Bupivacaine
A Phase 4 study testing OraVerse in people with Anesthesia, Local, run by Dalhousie University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Local
- What is being tested?
- OraVerse
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteCanada
- Study dates
- 10 Feb 2017to 15 Sep 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- capable of providing informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Dalhousie University Faculty of Dentistry
Halifax, Nova Scotia, B3H 4R2
About this study
Official title: Reversing the Effects of 0.5% Bupivacaine: A Randomized Controlled Trial
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).
Read the detailed description
Dental procedures often require the use of local anesthesia. The most common local anesthetic used is 2% Lidocaine 1:100,000 epinephrine. This local anesthetic can achieve soft tissue anesthesia for 180-300 minutes and pulpal anesthesia for 60 minutes. Unfortunately, for longer treatments this relatively short duration can lead to the loss of anesthetic effect before the end of the interventions. Time-demanding dental appointments include oral and periodontal surgeries, extensive restorative treatments, and even minor treatments when completed by dental students. Unfortunately, if a short acting anesthetic such as Lidocaine is being used during long lasting procedures, once the patients start feeling pain again, it may be difficult to reestablish deep pulpal anesthesia with a repeated injection due to tachyphylaxis. To avoid this situation long-acting local anesthetics could be selected instead. The only long-acting anesthetic available in dentistry is 0.5% Bupivacaine HCl, 1:200,000 epinephrine. Bupivacaine can produce soft tissue anesthesia for up to 12 hours (commonly 4 to 9 hours) and pulpal anesthesia for up to 7 hours (commonly 1.5 to 3 hours). Unfortunately, Bupivacaine is not often used for non-surgical procedures due to its very long soft tissue anesthesia that outlast treatments by several hours.
The effects of soft tissue anesthesia linger for some time after the administration of long acting local anesthetics such as Bupivacaine. This can lead to discomfort and occasionally injury from lip/tongue biting. 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). This will further advance our knowledge of both Bupivacaine and phentolamine mesylate as there are no current studies evaluating reversing the effect of Bupivacaine with PM.
It is hypothesized that phentolamine mesylate will reduce the duration of soft tissue anesthesia by 2.5 hours when compared with a control injection of saline water. It is anticipated that this study will determine the feasibility and sample size needed to conduct a full-scale multi-centre trial.
- Conditions
- Anesthesia, Local
- Being tested
- OraVerse, Saline Water (Control)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OraVerseDrug
Also called phentolamine mesylate
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.
Saline Water (Control)Drug
Also called Placebo
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | 1.7ml saline water Receives: Drug: Saline Water (Control) |
| OraVerse | Experimental | 1.7ml OraVerse Receives: Drug: OraVerse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to reversal of local anesthesia
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2016 (estimated)
- Study start10 Feb 2017
- Primary completion15 May 2019
- Study completion15 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, LocalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dalhousie University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pierre-Luc Michaud, Dalhousie University
- Investigators
- Pierre-Luc Michaud, DMD, MSc, FRCDC, Principal investigator, Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02995291
- Sponsor's protocol ID
- 2016-4014
- Status last verified
- Jan 2020
- First submitted
- 14 Dec 2016
- Last updated
- 29 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Aggregate data to be published in peer reviewed journal
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reversing the Effects of 0.5% Bupivacaine: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02995291
- Acronym / sponsor ID
- 2016-4014
- Conditions
- Anesthesia, Local
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Dalhousie UniversityUniversity, hospital or other
- Study start
- 10 Feb 2017 (actual)
- Primary completion
- 15 May 2019 (actual)
- Study completion
- 15 Sep 2019 (actual)
- First posted
- 16 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Dental procedures often require the use of local anesthesia. The most common local anesthetic used is 2% Lidocaine 1:100,000 epinephrine. This local anesthetic can achieve soft tissue anesthesia for 180-300 minutes and pulpal anesthesia for 60 minutes. Unfortunately, for longer treatments this relatively short duration can lead to the loss of anesthetic effect before the end of the interventions. Time-demanding dental appointments include oral and periodontal surgeries, extensive restorative treatments, and even minor treatments when completed by dental students. Unfortunately, if a short acting anesthetic such as Lidocaine is being used during long lasting procedures, once the patients start feeling pain again, it may be difficult to reestablish deep pulpal anesthesia with a repeated injection due to tachyphylaxis. To avoid this situation long-acting local anesthetics could be selected instead. The only long-acting anesthetic available in dentistry is 0.5% Bupivacaine HCl, 1:200,000 epinephrine. Bupivacaine can produce soft tissue anesthesia for up to 12 hours (commonly 4 to 9 hours) and pulpal anesthesia for up to 7 hours (commonly 1.5 to 3 hours). Unfortunately, Bupivacaine is not often used for non-surgical procedures due to its very long soft tissue anesthesia that outlast treatments by several hours.
The effects of soft tissue anesthesia linger for some time after the administration of long acting local anesthetics such as Bupivacaine. This can lead to discomfort and occasionally injury from lip/tongue biting. 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). This will further advance our knowledge of both Bupivacaine and phentolamine mesylate as there are no current studies evaluating reversing the effect of Bupivacaine with PM.
It is hypothesized that phentolamine mesylate will reduce the duration of soft tissue anesthesia by 2.5 hours when compared with a control injection of saline water. It is anticipated that this study will determine the feasibility and sample size needed to conduct a full-scale multi-centre trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: Saline Water (Control)1.7ml saline water |
| OraVerse | Experimental | Drug: OraVerse1.7ml OraVerse |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years of age or older
- capable of providing informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OraVerseAlso: phentolamine mesylate1.7ml 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 | OraVerse |
| Saline Water (Control)Also: Placebo1.7ml 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. | Drug | Control |
Primary outcome
Time to reversal of local anesthesia
Time frame: 8 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2020.
- Dalhousie University Faculty of Dentistry Web SiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. Aggregate data to be published in peer reviewed journal
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre-Luc Michaud, DMD, MSc, FRCDC principal investigator
Dalhousie University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing OraVerse in people with Anesthesia, Local, run by Dalhousie University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to reversal of local anesthesia (time frame: 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2020.