Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
COMPLETED
NCT05978687
PHASE4

The Use of Lidocaine Gel Versus Subconjunctival Xylocaine Injection in Pterygium Excision

Sponsor: Vrije Universiteit Brussel

View on ClinicalTrials.gov

Summary

In pterygium excision procedures, the subconjunctival injection of xylocain is regarded as an uncomfortable and painful step in the procedure. While already being studied in other ophthalmic procedures such as glaucoma surgery (7), application of topical lidocaine gel is likely to minimize pain. The gel has a longer surface contact time due to its consistency, providing not only a longer anesthetic effect, but protecting the corneal surface against desiccation, when compared to eye drops. The investigators hypothesize that Ophtesic 2% lidocaine gel is as effective as an anesthetic in pterygium excision as subconjunctival injection, while providing more comfort during surgery and less corneal dryness afterwards. Our goal is to compare both the anesthetic and corneal surface effect of topical 2% lidocaine gel to subconjunctival injection of xylocaine 2% solution with 0.125 epinephrine in pterygium surgery: * Compare the patients pain during and after surgery * Compare corneal dryness after surgery. * Evaluate possible secondary events

Official title: The Use of Lidocaine Ophtesic Gel Versus Subconjunctival Xylocaine Injection in Pterygium Excision

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

41

Start Date

2023-09-01

Completion Date

2025-12-31

Last Updated

2026-08-25

Healthy Volunteers

No

Conditions

Interventions

DRUG

OPHTESIC LIDOCAINE HYDROCHLORIDE 20MG/G

In group A, all patients will receive topical 2% lidocaine gel (ophtesic lidocaine hydrochloride 20 mg/G) prior to surgery. Operative technique A traction suture is applied at the superior limbus (Vicryl 6.0) with a Kocher. The head of the pterygium is separated from its body with scissors. Afterwards it is removed by blunt dissection. The subconjunctival tissue under the body of the lesion is removed. The conjunctival graft is separated from the Tenon's capsule for harvest by ballooning with SBSS in group A and by injection with 0.5 mL of 2% xylocaine in group B. The autograft is excised from the superior temporal side. Hereafter, the graft is secured to the recipient bed with sutures. The traction suture is removed. All operations are executed by the same surgeon.

DRUG

Xylocaine with Epinephrine

In group B, all patients will receive a subconjunctival injection with xylocaine 2% hydrochloride solution with 0.125 epinephrine will be injected with a 27-gauge needle. When asked for, patients will receive additional topical 1% lidocaine eye drops. Operative technique A traction suture is applied at the superior limbus (Vicryl 6.0) with a Kocher. The head of the pterygium is separated from its body with scissors. Afterwards it is removed by blunt dissection. The subconjunctival tissue under the body of the lesion is removed. The conjunctival graft is separated from the Tenon's capsule for harvest by ballooning with SBSS in group A and by injection with 0.5 mL of 2% xylocaine in group B. The autograft is excised from the superior temporal side. Hereafter, the graft is secured to the recipient bed with sutures. The traction suture is removed. All operations are executed by the same surgeon.

Locations (1)

UZ Brussel

Brussels, Brussels Capital, Belgium