Bupivacaine Versus Lidocaine on Inflammatory Regulation Following Endodontic Surgery
This study is testing a local anesthetic (numbing medicine) to suppress pain. Bupivacaine and lidocaine are FDA approved local anesthetics that may decrease pain following surgery. Patients will receive either 2% lidocaine, 0.5% bupivacaine, or placebo with epinephrine 1:200,000 as a numbing medicine at the end of root canal surgery. Small pieces of gum will be taken before and after surgery and 2 days later to analyze chemicals that may be related to pain sensation.
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
|Official Title:||Comparison of Bupivacaine vs Lidocaine on Inflammatory Regulation Following Endodontic Surgery: A Double-Blind, Randomized, Controlled Clinical Trial|
- Assess the local inflammatory response as measured by tissue expression of the prostanoid enzymes cyclooxygenase (COX-2) and other cytokines and inflammatory mediators. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
- Evaluate the clinical outcome of postoperative pain following endodontic surgery, as measured by pain category and visual analog scale (VAS) and postoperative analgesic requirements. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
|Study Start Date:||July 2008|
|Study Completion Date:||July 2010|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
Up to 5 capsules of 0.5% Bupivacaine with epinephrine given post-operatively.
Other Name: Marcain, Marcaine, Sensorcaine and Vivacaine.
Up to 5 capsules of 2% lidocaine with epinephrine as a reinforcement drug post-operatively
Other Name: Xylocaine
We hypothesize that the use of the LLA bupivacaine will promote local inflammation leading to increased pain and central sensitization as evaluated by increase in pain at later time points. Hence our main hypothesis to be evaluated and statistically tested for our primary endpoint (Aim 1) is:
HO: There is no difference in mean levels of biochemical mediators of inflammation between groups.
HA: The bupivacaine group has higher levels of biochemical mediators following surgery.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01060774
|United States, Maryland|
|University of Maryland, Baltimore College of Dental Surgery|
|Baltimore, Maryland, United States, 21201|
|Principal Investigator:||Sharon Gordon||University of Maryland, Baltimore College of Dental Surgery|
|Study Director:||Anastasia Mischenko||University of Maryland, Baltimore College of Dental Surgery|
|Study Director:||Morris Hicks||University of Maryland, Baltimore College of Dental Surgery|
|Study Director:||Ashraf Fouad||University of Maryland, Baltimore College of Dental Surgery|