PainPhase 4NCT01060774
Bupivacaine Versus Lidocaine on Inflammatory Regulation
A Phase 4 study testing Lidocaine and Bupivacaine in people with Pain, run by University of Maryland at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain
- What is being tested?
- Lidocaine and Bupivacaine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Jul 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland, Baltimore College of Dental Surgery
Baltimore, Maryland, 21201
About this study
Official title: 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.
Read the 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.
- Conditions
- Pain
- Being tested
- Lidocaine, Bupivacaine
- Keywords
- Bupivacaine, Inflammation, Pain, Local Anesthetic, peripheral sensitization
- Medical subject headings
- Pain, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Also called Xylocaine
Up to 5 capsules of 2% lidocaine with epinephrine as a reinforcement drug post-operatively
BupivacaineDrug
Also called Marcain, Marcaine, Sensorcaine and Vivacaine.
Up to 5 capsules of 0.5% Bupivacaine with epinephrine given post-operatively.
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine | Experimental | 0.5% bupivacaine/1:200,000 epinephrine Receives: Drug: Bupivacaine |
| Lidocaine | Experimental | 2% lidocaine/1:200,000 epinephrine Receives: Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
The subject-reported pain measured at 48 hours after surgery.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2010 (estimated)
- Study startJul 2008
- Primary completionJul 2009
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sharon Gordon, University of Maryland
- Investigators
- Sharon Gordon, Principal investigator, University of Maryland, Baltimore College of Dental SurgeryAnastasia Mischenko, Study director, University of Maryland, Baltimore College of Dental SurgeryMorris Hicks, Study director, University of Maryland, Baltimore College of Dental SurgeryAshraf Fouad, Study director, University of Maryland, Baltimore College of Dental Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01060774
- Sponsor's protocol ID
- HP-00043039
- Status last verified
- May 2018
- First submitted
- 31 Jan 2010
- Last updated
- 31 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Bupivacaine vs Lidocaine on Inflammatory Regulation Following Endodontic Surgery: A Double-Blind, Randomized, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT01060774
- Acronym / sponsor ID
- HP-00043039
- Conditions
- Pain
- Keywords
- Bupivacaine, Inflammation, Pain, Local Anesthetic, peripheral sensitization
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of MarylandUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 2 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine | Experimental | Drug: Bupivacaine0.5% bupivacaine/1:200,000 epinephrine |
| Lidocaine | Experimental | Drug: Lidocaine2% lidocaine/1:200,000 epinephrine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LidocaineAlso: XylocaineUp to 5 capsules of 2% lidocaine with epinephrine as a reinforcement drug post-operatively | Drug | Lidocaine |
| BupivacaineAlso: Marcain, Marcaine, Sensorcaine and Vivacaine.Up to 5 capsules of 0.5% Bupivacaine with epinephrine given post-operatively. | Drug | Bupivacaine |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharon Gordon principal investigator
University of Maryland, Baltimore College of Dental Surgery
Anastasia Mischenko study director
University of Maryland, Baltimore College of Dental Surgery
Morris Hicks study director
University of Maryland, Baltimore College of Dental Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaine and Bupivacaine in people with Pain, run by University of Maryland at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2018.