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Randomised Clinical Trial: Influence of Subconjunctival Anaesthesia Duration on Pain Perception During Intravitreal Injections

Randomised Clinical Trial: Influence of Subconjunctival Anaesthesia Duration on Pain Perception During Intravitreal Injections

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000463572
Enrollment
240
Registered
2024-04-15
Start date
2020-08-31
Completion date
2020-12-31
Last updated
2024-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

There has been no robust study conducted to determine the optimum wait time between subconjunctival anaesthetic injection and intravitreal injection. The aim of this study is to examine the relationship between the wait time and the perceived anaesthetic effect by patients. The objective is to ensure that clinicians provide adequate anaesthesia and comfort to our patients while efficiently managing the high volume of treatment demand. We hypothesise that the pain level experienced by patients during intravitreal injection procedure decreases with longer waiting time after subconjunctival anesthesia.

Interventions

The purpose of this study is to determine the optimal wait time between the subconjunctival anaesthetic injection and intravitreal injection, whilst maintaining clinical efficiency. This is a Single-blinded randomised clinical trial. Patients were randomly assigned to one of four groups of wait time: 2 minutes, 3 minutes, 4 minutes, or 5 minutes. Patient identification gets checked. Patient lies on the bed in supine position. Two drops of oxybuprocaine drops were installed to the eye. 5% povid

The purpose of this study is to determine the optimal wait time between the subconjunctival anaesthetic injection and intravitreal injection, whilst maintaining clinical efficiency. This is a Single-blinded randomised clinical trial. Patients were randomly assigned to one of four groups of wait time: 2 minutes, 3 minutes, 4 minutes, or 5 minutes. Patient identification gets checked. Patient lies on the bed in supine position. Two drops of oxybuprocaine drops were installed to the eye. 5% povidone is used to sterilise the eye. Subconjunctival anaesthetic injection (0.2ml of 2% lidocaine) is given. After timing the assigned wait time (2, 3, 4 or 5 minutes), intravitreal injection (bevacizumab, ranibizumab, aflibercept - all 0.05ml in volume) was given using 30g needle. Eye gets irrigated with normal saline. All injections were administered by two experienced injectors (one general practitioner, and one ophthalmology registrar). The questionnaire gets handed out to the patient to complete. Patients remain unaware of which group they get assigned to until they complete the questionnaire in order to reduce bias error. For those requiring bilateral injections, only first injected eye gets included in the study.

Sponsors

Jiyeon Kim
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Enrollment included patients scheduled for IVI treatment at the injection clinic. Patients receiving bilateral injections had only their first injected eye included in the study

Exclusion criteria

We excluded patients under 18, individuals with cognitive impairment, and those with communication challenges hindering informed consent and accurate questionnaire responses.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026