Transconjunctival vs Transcutaneous Anaesthesia in Oculoplastics

NCT04102878 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-09-25

No results posted yet for this study

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

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

Sponsors & Collaborators

  • University Hospital Southampton NHS Foundation Trust

    lead OTHER

Principal Investigators

  • We Fong Siah · University Hospitals Southampton NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-04
Primary Completion
2019-10-30
Completion
2019-11-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04102878 on ClinicalTrials.gov