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Trial registered on ANZCTR


Registration number
ACTRN12613000996763
Ethics application status
Approved
Date submitted
2/09/2013
Date registered
9/09/2013
Date last updated
9/09/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
A double blind randomised controlled trial assessing the effect of 30% topical lidocaine gel on reducing pain in patients presenting to a cosmetic surgery practice with either prominent periorbital or lateral temporal veins for treatment with Neodymium-Doped Yttrium Aluminum Garnet (ND:TAG))
Scientific title
In patients presenting to a cosmetic surgery practice with either prominent periorbital or lateral temporal veins, what is the effect of 30% topical lidocaine gel on pain as assessed on a visual analogue scale compared to placebo?
Secondary ID [1] 283127 0
Nil
Universal Trial Number (UTN)
U1111-1147-4973
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Periorbital and lateral temporal veins - cosmetic 289977 0
Condition category
Condition code
Surgery 290351 290351 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1cc volume of topical 30% lidocaine in Lipothene gel (Treatment).

This was a split body design such that for each patient, one side of the face received the treatment gel and the other side of the face received the placebo gel.

Both the treatment and the placebo gel was applied over prominent veins on the infra-orbit and/or lateral temporal area using a cotton tip applicator.

Only veins identified by the surgeon and patient undergoing the treatment was treated with the intervention.

The intervention and placebo gel remained on the patients face for 15 minutes.
Intervention code [1] 287848 0
Treatment: Drugs
Comparator / control treatment
1 cc of placebo (lubricating gel) applied topically.
Control group
Placebo

Outcomes
Primary outcome [1] 290384 0
The primary outcome measure was pain as assessed by a 100 mm visual analogue scale. This study utilized the definition of pain based on International Association for the Study of Pain.

Specifically, we defined pain as an unpleasant sensory and emotional experience associated with actual or potential tissue damage. Patients were advised to rate their pain based on their experience during the examination only.
Timepoint [1] 290384 0
10 minutes after completion of the laser treatment.
Secondary outcome [1] 304390 0
Nil
Timepoint [1] 304390 0
Nil

Eligibility
Key inclusion criteria
1. 18 years of age or older
2. Cosmetically significant lateral temporal or infra-orbital as subjectively judged by the patient
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. known sensitivity or allergy to any topical or other anaesthetic medication
2. unilateral veins only

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was concealed from both the patient and assessor during the treatment and trial. The individual who was responsible for enrolling patients was not aware of group allocation. Allocation was concealed from both patients and observes by storing allocation on a secure computer.

Subjects were asked not to communicate any subjective differences in sensation until after the treatment was complete to ensure the treating physician remained blinded to the treatment sides. If a patient noted a subjective difference any. This allocation data was stored on a secured computed in the clinic and was not available until completion of the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computerized random number generator (Research Randomizer 10 Online) was utilized by the research coordinator to randomize the patients’ side to each intervention group. The random number generator generated a unique number for each patient, and if an even number was generated, the treatment was applied to the right periorbital/temporal region, while odd numbers resulted in the treatment being applied to the left periorbital/temporal region. All patients received both the treatment and placebo. Once randomization was performed, there was no change to randomization after beginning the trial.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Other
Other design features
Split Body Design - Both interventions applied, one on each side of face at same time.
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis
A sample size calculation was conducted to determine the minimum sample required to answer the primary objective. Based on a previous pilot study 1,3 we estimated a minimal difference in pain between treatment and control of 2 cm (2/10 on a VAS) with a standard deviation of 2 cm. Based on this data, this study required a minimum of 10 patients to achieve the desired power of 80% at an alpha of 0.05.

For Data Testing

All statistics were analyzed using MINITAB (version 16.1.1; Minitab Inc., State College, PA, USA) statistical software.

Non-parametric testing was used for all outcomes. A Wilcoxon sign-rank test was used to compare treatment and control sides. We defined a significant difference as a p<0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 5353 0
Canada
State/province [1] 5353 0
Ontario

Funding & Sponsors
Funding source category [1] 287878 0
Self funded/Unfunded
Name [1] 287878 0
Address [1] 287878 0
Country [1] 287878 0
Canada
Primary sponsor type
University
Name
University of Toronto
Address
University of Toronto
1265 Military Trail
Toronto, Ontario M1C 1A4 Canada
Country
Canada
Secondary sponsor category [1] 286605 0
None
Name [1] 286605 0
Address [1] 286605 0
Country [1] 286605 0
Other collaborator category [1] 277598 0
Individual
Name [1] 277598 0
David Ellis
Address [1] 277598 0
University of Toronto - Art of Facial Plastic Surgery
167 Sheppard Avenue, West Toronto, M2N 1M9
Country [1] 277598 0
Canada

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289821 0
University of Toronto - Research Ethics Board
Ethics committee address [1] 289821 0
100 College Street
Toronto, ON, Canada
M5G 1L5
Ethics committee country [1] 289821 0
Canada
Date submitted for ethics approval [1] 289821 0
Approval date [1] 289821 0
01/08/2013
Ethics approval number [1] 289821 0
20139622-02H

Summary
Brief summary
Some individuals have cosmetically un-pleasing prominent blue veins under their eyes or in their temporal regions. Although there are a number of methods to treat these, a simple, effective and safe method is using a type of laser called ND:YAG which targets the blue pigment in the vein. Unfortunately, patients often describe this as uncomfortable or painful.

Therefore, the purpose of this study is to determine if using a lidocaine gel prior to treatment will result in a reduction in pain.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42582 0
Dr James P. Bonaparte
Address 42582 0
Department of Otolaryngology,
Ottawa Hospital-General Campus
S3, 501 Smyth Rd.
Ottawa, Ontario
Canada K1H 8L6
Country 42582 0
Canada
Phone 42582 0
0011-1-613-737-8899
Fax 42582 0
Email 42582 0
drjames.bonaparte@gmail.com
Contact person for public queries
Name 42583 0
Dr James P. Bonaparte
Address 42583 0
Department of Otolaryngology,
Ottawa Hospital-General Campus
S3, 501 Smyth Rd.
Ottawa, Ontario
Canada K1H 8L6
Country 42583 0
Canada
Phone 42583 0
0011-1-613-737-8899
Fax 42583 0
Email 42583 0
drjames.bonaparte@gmail.com
Contact person for scientific queries
Name 42584 0
Dr James P. Bonaparte
Address 42584 0
Department of Otolaryngology,
Ottawa Hospital-General Campus
S3, 501 Smyth Rd.
Ottawa, Ontario
Canada K1H 8L6
Country 42584 0
Canada
Phone 42584 0
0011-1-613-737-8899
Fax 42584 0
Email 42584 0
drjames.bonaparte@gmail.com

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary