Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000182392
Ethics application status
Approved
Date submitted
24/01/2017
Date registered
2/02/2017
Date last updated
2/02/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of two local anaesthetic techniques on pain scores during and after intravitreal injection
Scientific title
The intravitreal injection pain study: a randomised control study comparing subjective pain with local anaesthetic technique
Secondary ID [1] 290996 0
None
Universal Trial Number (UTN)
U1111-1191-9143
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Retinal disease 301762 0
Intravitreal injection 301764 0
Peri procedural pain 301765 0
Condition category
Condition code
Eye 301453 301453 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subcutaneous injection of 0.2mL of 2% lignocaine (SCI) was compared with topical pledget 0.5% amethocaine hydrochloride (TP) for peri procedural pain during intravitreal injections of anti VEGF agents. Patients received injections of bevacizumab (Avastin; Roche Australia, Dee Why, NSW), ranibizumab (Lucentis; Novartis, North Ryde, NSW) or aflibercept (Eylea; Bayer AG, Pymble, NSW) depending on the choice of their treating ophthalmologist for a variety of conditions.

All patients received 2 drops of 0.5% amethocaine hydrochloride spaced 1 minute apart, which were allowed to work for 2 minutes before progressing. In the SCI group, 0.2mL of 2% lignocaine was injected as a bleb in the superior-temporal region, followed by sterile preparation, then administration of the anti VGEF injection. In the TP group, following sterile preparation, a cotton bud soaked in 0.5% amethocaine hydrochloride was applied to the superior-temporal region for 30 seconds followed immediately by the anti-VEGF injection. Sterile preparation in both groups involved instillation of 1 drop of half strength 5% Povidone-iodine and positioning of an eyelid speculum.

In the first part of the trial, each participant received only one of the interventions (either SCI or TP local anaesthetic technique). In the second part of the trial, 67 out of the original 112 participants returned and received the opposite local anaesthetic technique for their next anti VGEF treatment. Duration between treatments were 4-6 weeks. Interventions were administered to one eye only.
Intervention code [1] 296953 0
Treatment: Drugs
Comparator / control treatment
lignocaine is compared to amethocaine hydrochloride
Control group
Active

Outcomes
Primary outcome [1] 300849 0
Pain scores on a visual analog scale
Timepoint [1] 300849 0
5 minutes after intravitreal injection
Primary outcome [2] 300850 0
Pain scores on visual analogue scale
Timepoint [2] 300850 0
24 hours after intravitreal injection
Secondary outcome [1] 331016 0
Patient preference for 1st or 2nd intravitreal injection
Timepoint [1] 331016 0
24 hours after 2nd intravitreal injection

Eligibility
Key inclusion criteria
Adult patients (over 18 years old) receiving sequential intravitreal anti VEGF injections
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
under 18 years of age, had a cognitive impairment, or were being treated less frequently than 3 monthly

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)
Central randomisation by research staff, then allocation related to treating doctor and nurse prior to intervention given.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
However only 67 out of the original 112 cohort were available for the opposite intervention.
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Non-parametric analysis was undertaken. Mann-Whitney calculations were used to determine association, with the level of significance set at a P value of less than 0.05.

Post hoc calculations show that with a sample size of 112, 75% power was achieved to detect a significance level of 0.05, assuming an effect size of 0.5, standard deviation 2.0 based on previous studies and a significant difference being 1.0 on the pain score.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/04/2015
Date of last participant enrolment
Anticipated
Actual
1/05/2015
Date of last data collection
Anticipated
Actual
11/06/2015
Sample size
Target
120
Accrual to date
Final
112
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 7370 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 15165 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 295420 0
Hospital
Name [1] 295420 0
Flinders Medical Centre
Country [1] 295420 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Flinders University
Flinders Drive
Bedford Park
SA
5042
Country
Australia
Secondary sponsor category [1] 294238 0
None
Name [1] 294238 0
Address [1] 294238 0
Country [1] 294238 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296751 0
Southern Adelaide Human Research Ethics Committee
Ethics committee address [1] 296751 0
Ethics committee country [1] 296751 0
Date submitted for ethics approval [1] 296751 0
Approval date [1] 296751 0
01/04/2015
Ethics approval number [1] 296751 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71954 0
Dr Matthew Crabb
Address 71954 0
Department of Ophthalmology
Flinders University, Flinders Medical Centre
Flinders Drive
Bedford Park
SA
5042
Country 71954 0
Australia
Phone 71954 0
+61 08 8277 0899
Fax 71954 0
Email 71954 0
[email protected]
Contact person for public queries
Name 71955 0
Ebony Liu
Address 71955 0
Department of Ophthalmology
Flinders University, Flinders Medical Centre
Flinders Drive
Bedford Park
SA
5042
Country 71955 0
Australia
Phone 71955 0
+61 08 82046985
Fax 71955 0
Email 71955 0
[email protected]
Contact person for scientific queries
Name 71956 0
Ebony Liu
Address 71956 0
Department of Ophthalmology
Flinders University, Flinders Medical Centre
Flinders Drive
Bedford Park
SA
5042
Country 71956 0
Australia
Phone 71956 0
+61 08 82046985
Fax 71956 0
Email 71956 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.