NCT04102878

Transconjunctival vs Transcutaneous Anaesthesia in Oculoplastics

Comparative Study of Transconjunctival vs. Transcutaneous Routes for Administration of Local Anaesthesia in Oculoplastic Surgery

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University Hospital Southampton NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anesthesia, Local
• Eyelid Diseases

Interventions

Type	Name	Description
DRUG	Topical Anesthetic	Topical anaesthetic drops (proxymetacaine 0.5% and tetracaine 1%) applied
PROCEDURE	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
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
OTHER	Patient comfort questionnaire	The patient will be asked to rate the level of pain during each local anaesthetic injection on a 0-10 scale
OTHER	Facial photograph	The patient will have a photograph taken following the anaesthetic injections to document the presence or absence of bruising
PROCEDURE	Eyelid surgery	Eyelid surgery will be performed as per the plan from their preoperative appointment

Timeline

• Start date: 2019-06-04
• Primary completion: 2019-10-30
• Completion: 2019-11-30
• First posted: 2019-09-25
• Last updated: 2019-09-25

Locations

1 site across 1 country: United Kingdom