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Transconjunctival vs Transcutaneous Anaesthesia in Oculoplastics

Primary Purpose

Anesthesia, Local, Eyelid Diseases

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Topical Anesthetic
Transconjunctival anaesthetic
Transcutaneous anaesthetic
Patient comfort questionnaire
Facial photograph
Eyelid surgery
Sponsored by
University Hospital Southampton NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anesthesia, Local focused on measuring oculoplastic surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Southampton NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Transcutaneous anaesthetic

Transconjunctival anaesthetic

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Requirement for additional anaesthetic
Requirement (or lack thereof) for additional 'top up' anaesthetic during the eyelid surgery.
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).
Other complications
Occurrence of any other complications or adverse events potentially attributable to the administration of local anaesthesia

Full Information

First Posted
April 5, 2019
Last Updated
September 24, 2019
Sponsor
University Hospital Southampton NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT04102878
Brief Title
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

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 4, 2019 (Actual)
Primary Completion Date
October 30, 2019 (Anticipated)
Study Completion Date
November 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Southampton NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Local, Eyelid Diseases
Keywords
oculoplastic surgery

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transcutaneous anaesthetic
Arm Type
Active Comparator
Arm Title
Transconjunctival anaesthetic
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Topical Anesthetic
Intervention Description
Topical anaesthetic drops (proxymetacaine 0.5% and tetracaine 1%) applied
Intervention Type
Procedure
Intervention Name(s)
Transconjunctival anaesthetic
Intervention Description
Local anaesthetic (50/50 mixture of bupivacaine 0.5% / lidocaine 2% with adrenaline 1:200 000) administered to the eyelid via the transconjunctival route
Intervention Type
Procedure
Intervention Name(s)
Transcutaneous anaesthetic
Intervention Description
Local anaesthetic (50/50 mixture of bupivacaine 0.5% / lidocaine 2% with adrenaline 1:200 000) administered to the eyelid via the transcutaneous route
Intervention Type
Other
Intervention Name(s)
Patient comfort questionnaire
Intervention Description
The patient will be asked to rate the level of pain during each local anaesthetic injection on a 0-10 scale
Intervention Type
Other
Intervention Name(s)
Facial photograph
Intervention Description
The patient will have a photograph taken following the anaesthetic injections to document the presence or absence of bruising
Intervention Type
Procedure
Intervention Name(s)
Eyelid surgery
Intervention Description
Eyelid surgery will be performed as per the plan from their preoperative appointment
Primary Outcome Measure Information:
Title
Pain during local anaesthetic administration
Description
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)
Time Frame
During local anaesthetic administration (2-3 minutes)
Secondary Outcome Measure Information:
Title
Requirement for additional anaesthetic
Description
Requirement (or lack thereof) for additional 'top up' anaesthetic during the eyelid surgery.
Time Frame
During surgical procedure (up to 1 hour)
Title
Bruising after local anaesthetic
Description
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).
Time Frame
Immediately after local anaesthetic (2-5 minutes)
Title
Other complications
Description
Occurrence of any other complications or adverse events potentially attributable to the administration of local anaesthesia
Time Frame
During anaesthetic administration, surgery, or up until the first postoperative visit (2-3 weeks later)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
We Fong Siah
Phone
0044 23 8120 4761
Email
we.siah@uhs.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
We Fong Siah
Organizational Affiliation
University Hospitals Southampton NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Southampton NHS Foundation Trust
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
SO16 5JT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Siah Fong
Phone
02381777222
Email
siahm1@uhs.nhs.uk

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34117385
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.
Results Reference
derived

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Transconjunctival vs Transcutaneous Anaesthesia in Oculoplastics

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