Transconjunctival vs Transcutaneous Anaesthesia in Oculoplastics

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

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.

Study Overview

• Status: Unknown
• Conditions: Anesthesia, Local; Eyelid Diseases
• Intervention / Treatment: Drug: Topical Anesthetic; Procedure: Transcutaneous anaesthetic; Other: Patient comfort questionnaire; Other: Facial photograph; Procedure: Eyelid surgery; Procedure: Transconjunctival anaesthetic

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Hampshire
    • Southampton, Hampshire, United Kingdom, SO16 5JT
      • Recruiting
      • University Hospital Southampton NHS Foundation Trust
      • Contact: Siah Fong; Phone Number: 02381777222; Email: siahm1@uhs.nhs.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Transcutaneous anaesthetic	Drug: Topical Anesthetic; Topical anaesthetic drops (proxymetacaine 0.5% and tetracaine 1%) applied; 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
ACTIVE_COMPARATOR: Transconjunctival anaesthetic	Drug: Topical Anesthetic; Topical anaesthetic drops (proxymetacaine 0.5% and tetracaine 1%) applied; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: University Hospital Southampton NHS Foundation Trust
• Investigators: Principal Investigator: We Fong Siah, University Hospitals Southampton NHS Foundation Trust

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 4, 2019
• Primary Completion (ANTICIPATED): October 30, 2019
• Study Completion (ANTICIPATED): November 30, 2019

Study Registration Dates

• First Submitted: April 5, 2019
• First Submitted That Met QC Criteria: September 24, 2019
• First Posted (ACTUAL): September 25, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 25, 2019
• Last Update Submitted That Met QC Criteria: September 24, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: oculoplastic surgery
• Additional Relevant MeSH Terms: Eye Diseases; Eyelid Diseases; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local
• Other Study ID Numbers: OPH0260

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No