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Bupivacaine Versus Lidocaine on Inflammatory Regulation Following Endodontic Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sharon Gordon, University of Maryland
ClinicalTrials.gov Identifier:
NCT01060774
First received: January 31, 2010
Last updated: June 25, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Pain
 Drug: Lidocaine
Drug: Bupivacaine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Official Title: Comparison of Bupivacaine vs Lidocaine on Inflammatory Regulation Following Endodontic Surgery: A Double-Blind, Randomized, Controlled Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • Assess the local inflammatory response as measured by tissue expression of the prostanoid enzymes cyclooxygenase (COX-2) and other cytokines and inflammatory mediators. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate the clinical outcome of postoperative pain following endodontic surgery, as measured by pain category and visual analog scale (VAS) and postoperative analgesic requirements. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: July 2008
Study Completion Date: July 2010
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bupivacaine Drug: Bupivacaine
Up to 5 capsules of 0.5% Bupivacaine with epinephrine given post-operatively.
Other Name: Marcain, Marcaine, Sensorcaine and Vivacaine.
Experimental: Lidocaine Drug: Lidocaine
Up to 5 capsules of 2% lidocaine with epinephrine as a reinforcement drug post-operatively
Other Name: Xylocaine

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01060774

Locations
United States, Maryland
University of Maryland, Baltimore College of Dental Surgery
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Sharon Gordon, Associate Professor, University of Maryland
ClinicalTrials.gov Identifier: NCT01060774     History of Changes
Other Study ID Numbers: HP-00043039
Study First Received: January 31, 2010
Last Updated: June 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Maryland:
Bupivacaine
Lidocaine
Inflammation
Pain
Local Anesthetic

Additional relevant MeSH terms:
Bupivacaine
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
 Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 22, 2013