Transconjunctival vs Transcutaneous Anaesthesia in Oculoplastics

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-04

Study Completion Date

2019-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Anesthesia, Local Eyelid Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Transcutaneous anaesthetic

Group Type ACTIVE_COMPARATOR

Topical Anesthetic

Intervention Type DRUG

Topical anaesthetic drops (proxymetacaine 0.5% and tetracaine 1%) applied

Transcutaneous anaesthetic

Intervention Type PROCEDURE

Local anaesthetic (50/50 mixture of bupivacaine 0.5% / lidocaine 2% with adrenaline 1:200 000) administered to the eyelid via the transcutaneous route

Patient comfort questionnaire

Intervention Type OTHER

The patient will be asked to rate the level of pain during each local anaesthetic injection on a 0-10 scale

Facial photograph

Intervention Type OTHER

The patient will have a photograph taken following the anaesthetic injections to document the presence or absence of bruising

Eyelid surgery

Intervention Type PROCEDURE

Eyelid surgery will be performed as per the plan from their preoperative appointment

Transconjunctival anaesthetic

Group Type ACTIVE_COMPARATOR

Topical Anesthetic

Intervention Type DRUG

Topical anaesthetic drops (proxymetacaine 0.5% and tetracaine 1%) applied

Transconjunctival anaesthetic

Intervention Type PROCEDURE

Local anaesthetic (50/50 mixture of bupivacaine 0.5% / lidocaine 2% with adrenaline 1:200 000) administered to the eyelid via the transconjunctival route

Transcutaneous anaesthetic

Intervention Type PROCEDURE

Local anaesthetic (50/50 mixture of bupivacaine 0.5% / lidocaine 2% with adrenaline 1:200 000) administered to the eyelid via the transcutaneous route

Patient comfort questionnaire

Intervention Type OTHER

The patient will be asked to rate the level of pain during each local anaesthetic injection on a 0-10 scale

Facial photograph

Intervention Type OTHER

The patient will have a photograph taken following the anaesthetic injections to document the presence or absence of bruising

Eyelid surgery

Intervention Type PROCEDURE

Eyelid surgery will be performed as per the plan from their preoperative appointment

Interventions

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Topical Anesthetic

Topical anaesthetic drops (proxymetacaine 0.5% and tetracaine 1%) applied

Intervention Type DRUG

Transconjunctival anaesthetic

Local anaesthetic (50/50 mixture of bupivacaine 0.5% / lidocaine 2% with adrenaline 1:200 000) administered to the eyelid via the transconjunctival route

Intervention Type PROCEDURE

Transcutaneous anaesthetic

Local anaesthetic (50/50 mixture of bupivacaine 0.5% / lidocaine 2% with adrenaline 1:200 000) administered to the eyelid via the transcutaneous route

Intervention Type PROCEDURE

Patient comfort questionnaire

The patient will be asked to rate the level of pain during each local anaesthetic injection on a 0-10 scale

Intervention Type OTHER

Facial photograph

The patient will have a photograph taken following the anaesthetic injections to document the presence or absence of bruising

Intervention Type OTHER

Eyelid surgery

Eyelid surgery will be performed as per the plan from their preoperative appointment

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No