Cutaneous AbscessEarly Phase 1NCT02066818
Injectable Lidocaine Versus Lidocaine/Tetracaine Patch for the Incision and Drainage of Skin Abscesses
A Early Phase 1 study testing Lidocaine/tetracaine patch and 1% lidocaine in people with Cutaneous Abscess and Pain, run by East Carolina University.
Trial summary
Local anesthesia used for incision and drainage of abscesses is known to be painful. We studied the analgesia provided by a lidocaine/tetracaine patch compared to injectable lidocaine during incision and drainage (I\&D) of skin abscesses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Abscess, Pain
- What is being tested?
- Lidocaine/tetracaine patch and 1% lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Jan 2010
- Phase
- Early Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age>18 years
- Skin abscess in need of incision and drainage (judged by treating physician)
Who cannot join
- Allergy to lidocaine or tetracaine
- Non-intact skin
- Unable/unwilling to provide informed consent
About this study
Official title: Injectable Lidocaine Provides Similar Analgesia Compared to Transdermal Lidocaine/Tetracaine Patch for the Incision and Drainage of Skin Abscesses: A Randomized Controlled Trial
Local anesthesia used for incision and drainage of abscesses is known to be painful.
We studied the analgesia provided by a lidocaine/tetracaine patch compared to injectable lidocaine during incision and drainage (I\&D) of skin abscesses.
Local injection of lidocaine provided similar analgesia compared to the lidocaine/tetracaine patch during I\&D of skin abscesses in the Emergency Department. Pain at presentation and following the procedure was similar in both groups.
- Conditions
- Cutaneous Abscess, Pain
- Being tested
- Lidocaine/tetracaine patch, 1% lidocaine
- Keywords
- local anesthetic, incision and drainage, pain, cutaneous abscess
- Medical subject headings
- Pain, Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine/tetracaine patchDrug
Also called Synera patch
1% lidocaineDrug
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine Injection | Active comparator | Incision and drainage performed after patient received placebo patch with injection of 1% lidocaine into the site of the abscess. Receives: Drug: 1% lidocaine |
| Lidocaine/tetracaine patch | Experimental | Incision and drainage performed after patient received active lidocaine/tetracaine patch and injection of 10cc of saline into site of abscess Receives: Drug: Lidocaine/tetracaine patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in VAS pain score over time
VAS measured at each of the 3 time points noted above.
Measured: Immediately prior to starting I&D (Time 0); 2-5 minutes after start of I&D (Time 1); within 1 minute of completion of I&D (Time 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2014 (estimated)
- Study startJan 2008
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous AbscessStudies 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Carolina University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina L. Bourne, East Carolina University
- Investigators
- Christina L Bourne, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02066818
- Sponsor's protocol ID
- ECUEM-Synera
- Status last verified
- Feb 2014
- First submitted
- 18 Nov 2013
- Last updated
- 20 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Injectable Lidocaine Provides Similar Analgesia Compared to Transdermal Lidocaine/Tetracaine Patch for the Incision and Drainage of Skin Abscesses: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02066818
- Acronym / sponsor ID
- ECUEM-Synera
- Conditions
- Cutaneous Abscess, Pain
- Keywords
- local anesthetic, incision and drainage, pain, cutaneous abscess
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- East Carolina UniversityUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 20 Feb 2014 (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.
Local anesthesia used for incision and drainage of abscesses is known to be painful.
We studied the analgesia provided by a lidocaine/tetracaine patch compared to injectable lidocaine during incision and drainage (I\&D) of skin abscesses.
Local injection of lidocaine provided similar analgesia compared to the lidocaine/tetracaine patch during I\&D of skin abscesses in the Emergency Department. Pain at presentation and following the procedure was similar in both groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine Injection | Active comparator | Drug: 1% lidocaineIncision and drainage performed after patient received placebo patch with injection of 1% lidocaine into the site of the abscess. |
| Lidocaine/tetracaine patch | Experimental | Drug: Lidocaine/tetracaine patchIncision and drainage performed after patient received active lidocaine/tetracaine patch and injection of 10cc of saline into site of abscess |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age>18 years
- Skin abscess in need of incision and drainage (judged by treating physician)
Key exclusion criteria (3 listed)
- Allergy to lidocaine or tetracaine
- Non-intact skin
- Unable/unwilling to provide informed consent
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 |
|---|---|---|
| Lidocaine/tetracaine patchAlso: Synera patch | Drug | Lidocaine/tetracaine patch |
| 1% lidocaine | Drug | Lidocaine Injection |
Primary outcome
Change in VAS pain score over time
Time frame: Immediately prior to starting I&D (Time 0); 2-5 minutes after start of I&D (Time 1); within 1 minute of completion of I&D (Time 2)
VAS measured at each of the 3 time points noted above.
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 20 Feb 2014.
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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.
Christina L Bourne, MD principal investigator
Medical University of South Carolina
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Lidocaine/tetracaine patch and 1% lidocaine in people with Cutaneous Abscess and Pain, run by East Carolina University.
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 2 inclusion and 3 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 20 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Change in VAS pain score over time (time frame: Immediately prior to starting I&D (Time 0); 2-5 minutes after start of I&D (Time 1); within 1 minute of completion of I&D (Time 2)). 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 20 Feb 2014.