Anesthesia, Local Clinical Trial
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).
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.
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