Transconjunctival vs Transcutaneous Anaesthesia in Oculoplastics

University Hospital Southampton NHS Foundation Trust

Status: Unknown

Conditions: Anesthesia, Local; Eyelid Diseases

Treatments: Procedure: Eyelid surgery; Procedure: Transconjunctival anaesthetic; Drug: Topical Anesthetic; Procedure: Transcutaneous anaesthetic; Other: Patient comfort questionnaire; Other: Facial photograph

Study type: Interventional

Funder types: Other

Identifiers

NCT04102878

OPH0260

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients undergoing bilateral oculoplastic procedures under local anaesthesia on selected lists at Southampton General Hospital or Lymington New Forest Hospital, UK
• able to give informed consent and adhere to the study protocol

Exclusion criteria

• patients undergoing substantially different procedures on each eye
• patients undergoing procedures not amenable to the administration of anaesthetic via the transconjunctival route (e.g. brow lift)
• patients undergoing a first procedure on one eye and a 'redo' procedure on the fellow eye (as the presence of scar tissue on the previously operated eye is likely to affect results)
• patients having their procedure under general anaesthesia, or receiving intravenous sedation prior to the administration of local anaesthetic

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 2 patient groups

Transcutaneous anaesthetic

Active Comparator group

Treatment:

Procedure: Transcutaneous anaesthetic

Drug: Topical Anesthetic

Procedure: Eyelid surgery

Other: Facial photograph

Other: Patient comfort questionnaire

Transconjunctival anaesthetic

Active Comparator group

Treatment:

Procedure: Transcutaneous anaesthetic

Procedure: Transconjunctival anaesthetic

Drug: Topical Anesthetic

Procedure: Eyelid surgery

Other: Facial photograph

Other: Patient comfort questionnaire