Bupivacaine Versus Lidocaine on Inflammatory Regulation
| Status: | Completed |
|---|---|
| Conditions: | Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 6/2/2018 |
| Start Date: | July 2008 |
| End Date: | July 2010 |
Comparison of Bupivacaine vs Lidocaine on Inflammatory Regulation Following Endodontic Surgery: A Double-Blind, Randomized, Controlled Clinical Trial
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.
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.
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.
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.
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
We found this trial at
1
site
650 West Baltimore Street
Baltimore, Maryland 21201
Baltimore, Maryland 21201
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