Bupivacaine Versus Lidocaine on Inflammatory Regulation

University of Maryland

Status and phase

Completed

Phase 4

Conditions

Pain

Treatments

Drug: Bupivacaine

Drug: Lidocaine

Study type

Interventional

Funder types

Other

Identifiers

NCT01060774

HP-00043039

Details and patient eligibility

About

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.

Full 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.

Enrollment

11 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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