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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupivacaine | Experimental | 0.5% bupivacaine/1:200,000 epinephrine |
|
| Lidocaine | Experimental | 2% lidocaine/1:200,000 epinephrine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug | Up to 5 capsules of 2% lidocaine with epinephrine as a reinforcement drug post-operatively |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess the local inflammatory response as measured by tissue expression of the prostanoid enzymes cyclooxygenase (COX-2) and other cytokines and inflammatory mediators. | The difference in inflammatory gene expression between treatment groups. | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the clinical outcome of postoperative pain following endodontic surgery, as measured by pain category and visual analog scale (VAS) and postoperative analgesic requirements. | The subject-reported pain measured at 48 hours after surgery. | 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sharon Gordon | University of Maryland, Baltimore College of Dental Surgery | Principal Investigator |
| 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 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland, Baltimore College of Dental Surgery | Baltimore | Maryland | 21201 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 23, 2017 | May 23, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Bupivacaine | Drug | Up to 5 capsules of 0.5% Bupivacaine with epinephrine given post-operatively. |
|
|
| Aniline Compounds |
| D000588 | Amines |