Transconjunctival vs Transcutaneous Anaesthesia in Oculoplastics

NCT04102878 | Unknown

• 1 other identifier: OPH0260
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia, Local; Eyelid Diseases

Keywords

oculoplastic surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Requirement for additional anaesthetic

  During surgical procedure (up to 1 hour)

• Bruising after local anaesthetic

  Immediately after local anaesthetic (2-5 minutes)

• Other complications

  During anaesthetic administration, surgery, or up until the first postoperative visit (2-3 weeks later)

Study Arms (2)

Transcutaneous anaesthetic

ACTIVE COMPARATOR

Drug: Topical Anesthetic; Procedure: Transcutaneous anaesthetic; Other: Patient comfort questionnaire; Other: Facial photograph; Procedure: Eyelid surgery

Transconjunctival anaesthetic

ACTIVE COMPARATOR

Drug: Topical Anesthetic; Procedure: Transconjunctival anaesthetic; Procedure: Transcutaneous anaesthetic; Other: Patient comfort questionnaire; Other: Facial photograph; Procedure: Eyelid surgery

Interventions

Topical Anesthetic DRUG

Topical anaesthetic drops (proxymetacaine 0.5% and tetracaine 1%) applied

Transconjunctival anaesthetic; Transcutaneous anaesthetic

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

Transconjunctival anaesthetic

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

Transconjunctival anaesthetic; Transcutaneous anaesthetic

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

Transconjunctival anaesthetic; Transcutaneous anaesthetic

Facial photograph OTHER

The patient will have a photograph taken following the anaesthetic injections to document the presence or absence of bruising

Transconjunctival anaesthetic; Transcutaneous anaesthetic

Eyelid surgery PROCEDURE

Eyelid surgery will be performed as per the plan from their preoperative appointment

Transconjunctival anaesthetic; Transcutaneous anaesthetic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead

Study Sites (1)

University Hospital Southampton NHS Foundation Trust

Southampton, Hampshire, SO16 5JT, United Kingdom

RECRUITING

Related Publications (1)

• 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.

  PMID: 34117385 DERIVED

MeSH Terms

Conditions

Eyelid Diseases

Interventions

Anesthetics, Local

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Officials

• We Fong Siah

  University Hospitals Southampton NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

We Fong Siah

CONTACT

0044 23 8120 4761; we.siah@uhs.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2019
• First Posted: September 25, 2019
• Study Start: June 4, 2019
• Primary Completion: October 30, 2019
• Study Completion: November 30, 2019
• Last Updated: September 25, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)