Transconjunctival vs Transcutaneous Anaesthesia in Oculoplastics

Anesthesia, Local Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04102878
• Other study ID #: OPH0260
• Status: Recruiting
• Phase: N/A
• Start date: June 4, 2019
• Est. completion date: November 30, 2019

Study information

• Verified date: September 2019
• Source: University Hospital Southampton NHS Foundation Trust
• Contact: We Fong Siah
• Phone: 0044 23 8120 4761
• Email: we.siah[@]uhs.nhs.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 30, 2019
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, Local
• Eyelid Diseases

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
United Kingdom	University Hospital Southampton NHS Foundation Trust	Southampton	Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Southampton NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Secondary	Requirement for additional anaesthetic	Requirement (or lack thereof) for additional 'top up' anaesthetic during the eyelid surgery.	During surgical procedure (up to 1 hour)
Secondary	Bruising after local anaesthetic	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)
Secondary	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)