Bupivacaine Versus Lidocaine on Inflammatory Regulation
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|ClinicalTrials.gov Identifier: NCT01060774|
Recruitment Status : Completed
First Posted : February 2, 2010
Last Update Posted : May 31, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pain||Drug: Lidocaine Drug: Bupivacaine||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Comparison of Bupivacaine vs Lidocaine on Inflammatory Regulation Following Endodontic Surgery: A Double-Blind, Randomized, Controlled Clinical Trial|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||July 2010|
0.5% bupivacaine/1:200,000 epinephrine
Up to 5 capsules of 0.5% Bupivacaine with epinephrine given post-operatively.
Other Name: Marcain, Marcaine, Sensorcaine and Vivacaine.
2% lidocaine/1:200,000 epinephrine
Up to 5 capsules of 2% lidocaine with epinephrine as a reinforcement drug post-operatively
Other Name: Xylocaine
- 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 ]The difference in inflammatory gene expression between treatment groups.
- 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 ]The subject-reported pain measured at 48 hours after surgery.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|