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The effect of two local anaesthetic techniques on pain scores during and after intravitreal injection

The intravitreal injection pain study: a randomised control study comparing subjective pain with local anaesthetic technique

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617000182392
Enrollment
112
Registered
2017-02-02
Start date
2015-04-01
Completion date
2015-05-01
Last updated
2017-02-06

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

Conditions

None listed

Brief summary

We performed a prospective randomized clinical trial to compare the pain experienced by patients who undergo either topical pledget or subconjunctival injection anaesthetic prior to intravitreal injection. 112 patients were recruited, randomised, blinded to anaesthetic method and administered either a topical pledget anaesthetic with 0.5% amethocaine hydrochloride or a 2% lignocaine subconjunctival injection. 5 minutes after intravitreal injection, a Visual Analog Scale was used to determine pain and this was repeated at 24 hours post injection via phone. 67 patients returned to the clinic and underwent the opposite anaesthetic technique for their next intravitreal injection. Pain scores were repeated at 5 minutes and 24 hours post injection. Patients were asked whether they preferred the first or second injection. Median pain scores out of 10 were low in both groups, but median 5 minute post injection pain was significantly lower in the subconjunctival injection group compared with the topical pledget group (SC= 1/10, TP= 2.5/10, U=1063, z=-2.97, p=0.003, r=.28). No significant difference in pain was evident in 24 hours post injection. 24 hour pain scores were significantly higher in those who had less than 10 previous injections (p=0.005). The preferred injection was subconjunctival injection in 75% of patients who had a repeated injection. SCI over TP anaesthetic may provide a superior modality of pain relief for intravitreal injections.

Interventions

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 dro

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.

Sponsors

Flinders University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

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

Inclusion criteria

Adult patients (over 18 years old) receiving sequential intravitreal anti VEGF injections

Exclusion criteria

under 18 years of age, had a cognitive impairment, or were being treated less frequently than 3 monthly

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026