Bupivacaine Versus Lidocaine on Inflammatory Regulation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2010-07-31

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.

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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.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Bupivacaine

0.5% bupivacaine/1:200,000 epinephrine

Group Type EXPERIMENTAL

Bupivacaine

Intervention Type DRUG

Up to 5 capsules of 0.5% Bupivacaine with epinephrine given post-operatively.

Lidocaine

2% lidocaine/1:200,000 epinephrine

Group Type EXPERIMENTAL

Lidocaine

Intervention Type DRUG

Up to 5 capsules of 2% lidocaine with epinephrine as a reinforcement drug post-operatively

Interventions

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Lidocaine

Up to 5 capsules of 2% lidocaine with epinephrine as a reinforcement drug post-operatively

Intervention Type DRUG

Bupivacaine

Up to 5 capsules of 0.5% Bupivacaine with epinephrine given post-operatively.

Intervention Type DRUG

Other Intervention Names

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Xylocaine Marcain, Marcaine, Sensorcaine and Vivacaine.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No