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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcutaneous anaesthetic | Active Comparator |
| |
| Transconjunctival anaesthetic | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical Anesthetic | Drug | Topical anaesthetic drops (proxymetacaine 0.5% and tetracaine 1%) applied |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain during local anaesthetic administration | 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) | During local anaesthetic administration (2-3 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Requirement for additional anaesthetic | Requirement (or lack thereof) for additional 'top up' anaesthetic during the eyelid surgery. | During surgical procedure (up to 1 hour) |
| Bruising after local anaesthetic |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| We Fong Siah | Contact | 0044 23 8120 4761 | we.siah@uhs.nhs.uk |
| Name | Affiliation | Role |
|---|---|---|
| We Fong Siah | University Hospitals Southampton NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Southampton NHS Foundation Trust | Recruiting | Southampton | Hampshire | SO16 5JT | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34117385 | Derived | Jawad M, Chow K, Nicholson R, Jonas A, Siah WF. Transconjunctival versus transcutaneous local anaesthetic administration for lower eyelid surgery: a randomised controlled trial. Eye (Lond). 2022 May;36(5):1094-1099. doi: 10.1038/s41433-021-01588-w. Epub 2021 Jun 11. |
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| Transconjunctival anaesthetic | 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 | 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 | Other | The patient will be asked to rate the level of pain during each local anaesthetic injection on a 0-10 scale |
|
| Facial photograph | Other | The patient will have a photograph taken following the anaesthetic injections to document the presence or absence of bruising |
|
| Eyelid surgery | Procedure | Eyelid surgery will be performed as per the plan from their preoperative appointment |
|
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).
| Immediately after local anaesthetic (2-5 minutes) |
| Other complications | Occurrence of any other complications or adverse events potentially attributable to the administration of local anaesthesia | During anaesthetic administration, surgery, or up until the first postoperative visit (2-3 weeks later) |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000779 | Anesthetics, Local |
| ID | Term |
|---|---|
| D000777 | Anesthetics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
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