Bupivacaine Versus Lidocaine on Inflammatory Regulation

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Maryland; University of Maryland, College Park
• Treatments: Bupivacaine; Lidocaine

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