Bupivacaine Versus Lidocaine on Inflammatory Regulation
Completed · Phase 4
Conditions studied: Pain
In brief
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.
Key facts
- Study ID
- NCT01060774
- Run by
- University of Maryland
- People needed
- 11
- Starts
- 2008-07-01
- Expected to finish
- 2010-07-01
- Last updated by the study team
- 2018-05-31
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Maryland, Baltimore College of Dental Surgery — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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