Transconjunctival vs Transcutaneous Anaesthesia in Oculoplastics

Not Applicable

• Conditions: Eyelid Diseases; Anesthesia, Local
• Interventions: Drug: Topical Anesthetic; Procedure: Transcutaneous anaesthetic; Procedure: Transconjunctival anaesthetic; Other: Facial photograph; Other: Patient comfort questionnaire; Procedure: Eyelid surgery

• Registration Number: NCT04102878
• Lead Sponsor: University Hospital Southampton NHS Foundation Trust

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-05
• Study Start: 2019-06-04
• Status Verified: 2019-09
• Study First Submitted QC: 2019-09-24
• Last Update Submitted: 2019-09-24
• Study First Posted: 2019-09-25
• Last Update Posted: 2019-09-25
• Primary Completion: 2019-10-30
• Study Completion: 2019-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Transcutaneous anaesthetic	Transcutaneous anaesthetic	-
Transcutaneous anaesthetic	Facial photograph	-
Transcutaneous anaesthetic	Eyelid surgery	-
Transconjunctival anaesthetic	Transconjunctival anaesthetic	-
Transconjunctival anaesthetic	Transcutaneous anaesthetic	-
Transconjunctival anaesthetic	Eyelid surgery	-
Transconjunctival anaesthetic	Patient comfort questionnaire	-
Transcutaneous anaesthetic	Topical Anesthetic	-
Transcutaneous anaesthetic	Patient comfort questionnaire	-
Transconjunctival anaesthetic	Facial photograph	-
Transconjunctival anaesthetic	Topical Anesthetic	-

Primary Outcome Measures

Name	Time	Method
Pain during local anaesthetic administration	During local anaesthetic administration (2-3 minutes)	Patient-rated pain intensity during administration of local anaesthetic via each route (transconjunctival and transcutaneous), expressed on a 0-10 scale (0 being no pain at all and 10 being the worst pain possible)

Secondary Outcome Measures

Name	Time	Method
Requirement for additional anaesthetic	During surgical procedure (up to 1 hour)	Requirement (or lack thereof) for additional 'top up' anaesthetic during the eyelid surgery.
Other complications	During anaesthetic administration, surgery, or up until the first postoperative visit (2-3 weeks later)	Occurrence of any other complications or adverse events potentially attributable to the administration of local anaesthesia
Bruising after local anaesthetic	Immediately after local anaesthetic (2-5 minutes)	Amount of bruising visible on facial photographs taken after the anaesthetic is administered but before the eyelid surgery, rated on a numeric scale of 0-3 by an independent assessor (i.e. a member of the research team who did not perform the anaesthetic or surgery).

Trial Locations

Locations (1)

University Hospital Southampton NHS Foundation Trust; 🇬🇧 Southampton, Hampshire, United Kingdom