Bupivacaine Versus Lidocaine on Inflammatory Regulation

Pain Clinical Trial

Official title:

Comparison of Bupivacaine vs Lidocaine on Inflammatory Regulation Following Endodontic Surgery: A Double-Blind, Randomized, Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01060774
• Other study ID #: HP-00043039
• Status: Completed
• Phase: Phase 4
• Start date: July 2008
• Est. completion date: July 2010

Study information

• Verified date: May 2018
• Source: University of Maryland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: July 2010
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Lidocaine
Up to 5 capsules of 2% lidocaine with epinephrine as a reinforcement drug post-operatively
• Bupivacaine
Up to 5 capsules of 0.5% Bupivacaine with epinephrine given post-operatively.

Locations

Country	Name	City	State
United States	University of Maryland, Baltimore College of Dental Surgery	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the local inflammatory response as measured by tissue expression of the prostanoid enzymes cyclooxygenase (COX-2) and other cytokines and inflammatory mediators.	The difference in inflammatory gene expression between treatment groups.	48 hours
Secondary	Evaluate the clinical outcome of postoperative pain following endodontic surgery, as measured by pain category and visual analog scale (VAS) and postoperative analgesic requirements.	The subject-reported pain measured at 48 hours after surgery.	48 hours