Bupivacaine Versus Lidocaine on Inflammatory Regulation

NCT01060774 | Completed Phase 4

• 1 other identifier: HP-00043039
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Bupivacaine; Inflammation; Pain; Local Anesthetic; peripheral sensitization

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

Bupivacaine

EXPERIMENTAL

0.5% bupivacaine/1:200,000 epinephrine

Drug: Bupivacaine

Lidocaine

EXPERIMENTAL

2% lidocaine/1:200,000 epinephrine

Drug: Lidocaine

Interventions

Lidocaine DRUG

Up to 5 capsules of 2% lidocaine with epinephrine as a reinforcement drug post-operatively

Also known as: Xylocaine

Lidocaine

Bupivacaine DRUG

Up to 5 capsules of 0.5% Bupivacaine with epinephrine given post-operatively.

Also known as: Marcain, Marcaine, Sensorcaine and Vivacaine.

Bupivacaine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland: lead

Study Sites (1)

University of Maryland, Baltimore College of Dental Surgery

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Pain; Inflammation

Interventions

Lidocaine; Bupivacaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Sharon Gordon

  University of Maryland, Baltimore College of Dental Surgery

  PRINCIPAL INVESTIGATOR

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 31, 2010
• First Posted: February 2, 2010
• Study Start: July 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2010
• Last Updated: May 31, 2018

Record last verified: 2018-05

Locations

US (1)