Clinical trial NCT04102878: Transconjunctival vs Transcutaneous Anaesthesia in Oculoplastics
Official title: Comparative Study of Transconjunctival vs. Transcutaneous Routes for Administration of Local Anaesthesia in Oculoplastic Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia, Local
Eyelid Diseases
Keywords: oculoplastic surgery
Lead sponsor: University Hospital Southampton NHS Foundation Trust
Sponsor class: OTHER
First posted: 2019-09-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pain during local anaesthetic administration
timeFrame: During local anaesthetic administration (2-3 minutes)
Secondary outcomes:
measure: Requirement for additional anaesthetic
timeFrame: During surgical procedure (up to 1 hour)
measure: Bruising after local anaesthetic
timeFrame: Immediately after local anaesthetic (2-5 minutes)
measure: Other complications
timeFrame: During anaesthetic administration, surgery, or up until the first postoperative visit (2-3 weeks later)
Other outcomes:
Locations:
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS Foundation Trust
state: Hampshire
Study officials:
affiliation: University Hospitals Southampton NHS Foundation Trust
name: We Fong Siah
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.