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Trial record 7 of 1229 for:    University of Maryland, Baltimore

Bupivacaine Versus Lidocaine on Inflammatory Regulation Following Endodontic Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01060774
First Posted: February 2, 2010
Last Update Posted: October 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sharon Gordon, University of Maryland
  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: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
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:


Further study details as provided by Sharon Gordon, 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 ]
    The difference in inflammatory gene expression between treatment groups.


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 ]
    The subject-reported pain measured at 48 hours after surgery.


Enrollment: 11
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
0.5% bupivacaine/1:200,000 epinephrine
Drug: Bupivacaine
Up to 5 capsules of 0.5% Bupivacaine with epinephrine given post-operatively.
Other Name: 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 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Sharon Gordon, Associate Professor, University of Maryland
ClinicalTrials.gov Identifier: NCT01060774     History of Changes
Other Study ID Numbers: HP-00043039
First Submitted: January 31, 2010
First Posted: February 2, 2010
Last Update Posted: October 9, 2017
Last Verified: October 2017

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

Additional relevant MeSH terms:
Lidocaine
Bupivacaine
Epinephrine
Racepinephrine
Epinephryl borate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents