Bupivacaine Versus Lidocaine on Inflammatory Regulation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparison of Bupivacaine vs Lidocaine on Inflammatory Regulation Following Endodontic Surgery: A Double-Blind, Randomized, Controlled Clinical Trial

Conditions
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Pain

Intervention / Treatment
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* Drug: Lidocaine
* Drug: Bupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female volunteers referred for endodontic surgery willing to undergo 2 visits: 1 surgical appointment, and 1 follow-up research-related appointment Ages of 18 and older Willing to undergo observation for 1/2 hour post-operatively Willing to complete a 100 mm visual analog scale and record analgesic intake over 48 hrs period Willing to have a preoperative and postoperative biopsy on the day of surgery Willing to return at 48 hours post-operation to turn in completed pain diaries and for the third biopsy Exclusion Criteria: Allergy to or other contraindications to use of aspirin, sulfites, amide anesthetics, or acetaminophen Chronic use of medications confounding the assessment of the inflammatory response or analgesia, for example, NSAIDS, COX-2 inhibitors, antihistamines, steroids, antidepressants Medications contraindicated with bupivacaine: MAO inhibitors and anti-depressants Diseases such as diabetes mellitus, liver disease, chronic infections, rheumatoid arthritis or any other systemic disease that compromises the immune system Unusual surgical difficulty

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bupivacaine<br>0.5% bupivacaine/1:200,000 epinephrine | Drug: Bupivacaine<br>* Up to 5 capsules of 0.5% Bupivacaine with epinephrine given post-operatively.<br>* Other names: Marcain, Marcaine, Sensorcaine and Vivacaine.;|
| Experimental: Lidocaine<br>2% lidocaine/1:200,000 epinephrine | Drug: Lidocaine<br>* Up to 5 capsules of 2% lidocaine with epinephrine as a reinforcement drug post-operatively<br>* Other names: Xylocaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bupivacaine, Inflammation, Pain, Local Anesthetic, peripheral sensitization