NCT04102878

Transconjunctival vs Transcutaneous Anaesthesia in Oculoplastics

Status unknown NA Last updated 25 September 2019

What this trial tests

NA trial testing Topical Anesthetic in Anesthesia, Local in 30 participants. Status unknown.

Timeline

4 June 2019

Primary endpoint
30 October 2019

30 November 2019

Quick facts

Lead sponsor	University Hospital Southampton NHS Foundation Trust
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	30
Start date	4 June 2019
Primary completion	30 October 2019
Estimated completion	30 November 2019
Sites	1 location across United Kingdom

Drugs / interventions tested

• Topical Anesthetic — full drug profile →
• Transconjunctival anaesthetic
• Transcutaneous anaesthetic
• Patient comfort questionnaire
• Facial photograph
• Eyelid surgery

Conditions studied

• Anesthesia, Local — all drugs for Anesthesia, Local →
• Eyelid Diseases — all drugs for Eyelid Diseases →

Sponsor

University Hospital Southampton NHS Foundation Trust

Who can join

18 and older, any sex, with Anesthesia, Local or Eyelid Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Eyelid surgery is commonly performed under local anaesthesia. For many such procedures, the local anaesthetic injection may be given either transcutaneously (through the skin) or transconjunctivally (through the conjunctiva, i.e. from the inner surface of the eyelid after administration of topical anaesthetic drops). Both methods are commonly used, sometimes in combination. Currently, the choice of route is largely determined by surgeon preference, but it is not known whether one method is better or more comfortable than the other. Our study will compare the two methods of local anaesthetic administration, in terms of patient comfort during anaesthetic administration, efficacy (i.e. whether any additional anaesthetic is needed during surgery), and adverse effects (e.g. bruising, postoperative double vision).

We will recruit adult patients who are due to undergo eyelid surgery on both sides under local anaesthesia, on Miss Siah's lists at Southampton General Hospital or Lymington Hospital. Patients will receive topical anaesthetic eye drops to both eyes, followed by an injection of local anaesthetic to each eyelid. One side will be administered transcutaneously, and the other side transconjunctivally. The order be randomised. After the injections, participants will be asked to rate their pain levels during each injection on a standardised numerical scale (1-10). A photograph will also be taken, so that an independent assessor can subsequently rate the extent of any bruising. The eyelid surgery will then be performed as normal, with any need for further anaesthetic during the surgery being recorded. Patients will attend for their normal follow-up appointment afterwards and any postoperative complications will be recorded, but the study will not require any extra hospital visits. The study is sponsored by University Hospitals NHS Foundation Trust, but does not have any external funding.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Transconjunctival versus transcutaneous local anaesthetic administration for lower eyelid surgery: a randomised controlled trial.
   Jawad M, Chow K, Nicholson R, Jonas A, et al · · 2022 · cited 2× · PMID 34117385 · DOI 10.1038/s41433-021-01588-w