Bupivacaine Versus Lidocaine on Inflammatory Regulation Following Endodontic Surgery

Condition(s) targeted: Pain

Intervention: Lidocaine (Drug); Bupivacaine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University of Maryland

Official(s) and/or principal investigator(s):
Sharon Gordon, Principal Investigator, Affiliation: University of Maryland, Baltimore College of Dental Surgery
Anastasia Mischenko, Study Director, Affiliation: University of Maryland, Baltimore College of Dental Surgery
Morris Hicks, Study Director, Affiliation: University of Maryland, Baltimore College of Dental Surgery
Ashraf Fouad, Study Director, Affiliation: University of Maryland, Baltimore College of Dental 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.

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

Study design: Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Primary outcome: Assess the local inflammatory response as measured by tissue expression of the prostanoid enzymes cyclooxygenase (COX-2) and other cytokines and inflammatory mediators.

Secondary outcome: Evaluate the clinical outcome of postoperative pain following endodontic surgery, as measured by pain category and visual analog scale (VAS) and postoperative analgesic requirements.

Detailed description: 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.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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

University of Maryland, Baltimore College of Dental Surgery, Baltimore, Maryland 21201, United States

Starting date: July 2008
Last updated: July 9, 2013