Bupivacaine Versus Lidocaine on Inflammatory Regulation

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Bupivacaine; Drug: Lidocaine

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 Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland, Baltimore College of Dental Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bupivacaine; 0.5% bupivacaine/1:200,000 epinephrine	Drug: Bupivacaine; Up to 5 capsules of 0.5% Bupivacaine with epinephrine given post-operatively.; Other Names: Marcain, Marcaine, Sensorcaine and Vivacaine.
Experimental: Lidocaine; 2% lidocaine/1:200,000 epinephrine	Drug: Lidocaine; Up to 5 capsules of 2% lidocaine with epinephrine as a reinforcement drug post-operatively; Other Names: Xylocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Maryland
• Investigators: Principal Investigator: Sharon Gordon, University of Maryland, Baltimore College of Dental Surgery; Study Director: Anastasia Mischenko, University of Maryland, Baltimore College of Dental Surgery; Study Director: Morris Hicks, University of Maryland, Baltimore College of Dental Surgery; Study Director: Ashraf Fouad, University of Maryland, Baltimore College of Dental Surgery

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: January 31, 2010
• First Submitted That Met QC Criteria: February 1, 2010
• First Posted (Estimate): February 2, 2010

Study Record Updates

• Last Update Posted (Actual): May 31, 2018
• Last Update Submitted That Met QC Criteria: May 29, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Inflammation; Pain; Local Anesthetic; Bupivacaine; peripheral sensitization
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Bupivacaine
• Other Study ID Numbers: HP-00043039