Bupivacaine Versus Lidocaine on Inflammatory Regulation

Phase 4

Completed

• Conditions: Pain
• Interventions: Drug: Bupivacaine; Drug: Lidocaine

• Registration Number: NCT01060774
• Lead Sponsor: University of Maryland

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.

Study Timeline

• Study Start: 2008-07
• Primary Completion: 2009-07
• Study First Submitted: 2010-01-31
• Study First Submitted QC: 2010-02-01
• Study First Posted: 2010-02-02
• Study Completion: 2010-07
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-29
• Last Update Posted: 2018-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bupivacaine	Bupivacaine	0.5% bupivacaine/1:200,000 epinephrine
Lidocaine	Lidocaine	2% lidocaine/1:200,000 epinephrine

Primary Outcome Measures

Name	Time	Method
Assess the local inflammatory response as measured by tissue expression of the prostanoid enzymes cyclooxygenase (COX-2) and other cytokines and inflammatory mediators.	48 hours	The difference in inflammatory gene expression between treatment groups.

Secondary Outcome Measures

Name	Time	Method
Evaluate the clinical outcome of postoperative pain following endodontic surgery, as measured by pain category and visual analog scale (VAS) and postoperative analgesic requirements.	48 hours	The subject-reported pain measured at 48 hours after surgery.

Trial Locations

Locations (1)

University of Maryland, Baltimore College of Dental Surgery; 🇺🇸 Baltimore, Maryland, United States