Clinical trial NCT01060774: Bupivacaine Versus Lidocaine on Inflammatory Regulation
Official title: Comparison of Bupivacaine vs Lidocaine on Inflammatory Regulation Following Endodontic Surgery: A Double-Blind, Randomized, Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: Bupivacaine
Inflammation
Pain
Local Anesthetic
peripheral sensitization
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2010-02-02
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

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.

Eligibility 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

Primary outcomes:
measure: Assess the local inflammatory response as measured by tissue expression of the prostanoid enzymes cyclooxygenase (COX-2) and other cytokines and inflammatory mediators.
timeFrame: 48 hours
Secondary outcomes:
measure: Evaluate the clinical outcome of postoperative pain following endodontic surgery, as measured by pain category and visual analog scale (VAS) and postoperative analgesic requirements.
timeFrame: 48 hours
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland, Baltimore College of Dental Surgery
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore College of Dental Surgery
name: Sharon Gordon
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Maryland, Baltimore College of Dental Surgery
name: Anastasia Mischenko
role: STUDY_DIRECTOR
affiliation: University of Maryland, Baltimore College of Dental Surgery
name: Morris Hicks
role: STUDY_DIRECTOR
affiliation: University of Maryland, Baltimore College of Dental Surgery
name: Ashraf Fouad
role: STUDY_DIRECTOR
References: