Anesthesia, LocalNCT04102878
Transconjunctival vs Transcutaneous Anaesthesia in Oculoplastics
A study testing Topical Anesthetic, Transconjunctival anaesthetic and Transcutaneous anaesthetic in people with Anesthesia, Local and Eyelid Diseases, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Local, Eyelid Diseases
- What is being tested?
- Topical Anesthetic, Transconjunctival anaesthetic and Transcutaneous anaesthetic
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Jun 2019to 30 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, SO16 5JT
Siah Fong, 02381777222, siahm1@uhs.nhs.uk
About this study
Official title: 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.
- Conditions
- Anesthesia, Local, Eyelid Diseases
- Being tested
- Topical Anesthetic, Transconjunctival anaesthetic, Transcutaneous anaesthetic, Patient comfort questionnaire, Facial photograph
- Keywords
- oculoplastic surgery
- Medical subject headings
- Eyelid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical AnestheticDrug
Topical anaesthetic drops (proxymetacaine 0.5% and tetracaine 1%) applied
Transconjunctival anaestheticProcedure or surgery
Local anaesthetic (50/50 mixture of bupivacaine 0.5% / lidocaine 2% with adrenaline 1:200 000) administered to the eyelid via the transconjunctival route
Transcutaneous anaestheticProcedure or surgery
Local anaesthetic (50/50 mixture of bupivacaine 0.5% / lidocaine 2% with adrenaline 1:200 000) administered to the eyelid via the transcutaneous route
Patient comfort questionnaireOther
The patient will be asked to rate the level of pain during each local anaesthetic injection on a 0-10 scale
Facial photographOther
The patient will have a photograph taken following the anaesthetic injections to document the presence or absence of bruising
Eyelid surgeryProcedure or surgery
Eyelid surgery will be performed as per the plan from their preoperative appointment
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous anaesthetic | Active comparator | Not described Receives: Drug: Topical Anesthetic; Procedure: Transcutaneous anaesthetic; Other: Patient comfort questionnaire; Other: Facial photograph; Procedure: Eyelid surgery |
| Transconjunctival anaesthetic | Active comparator | Not described Receives: Drug: Topical Anesthetic; Procedure: Transconjunctival anaesthetic; Procedure: Transcutaneous anaesthetic; Other: Patient comfort questionnaire; Other: Facial photograph; Procedure: Eyelid surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: During local anaesthetic administration (2-3 minutes)
Secondary outcomes (3)
Requirement for additional anaesthetic
Requirement (or lack thereof) for additional 'top up' anaesthetic during the eyelid surgery.
Measured: 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).
Measured: 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
Measured: During anaesthetic administration, surgery, or up until the first postoperative visit (2-3 weeks later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start4 Jun 2019
- Primary completion30 Oct 2019 (estimated)
- Study completion30 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, LocalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- We Fong Siah, Principal investigator, University Hospitals Southampton NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04102878
- Sponsor's protocol ID
- OPH0260
- Status last verified
- Sep 2019
- First submitted
- 5 Apr 2019
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34117385
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Transconjunctival vs. Transcutaneous Routes for Administration of Local Anaesthesia in Oculoplastic Surgery
- ClinicalTrials.gov ID
- NCT04102878
- Acronym / sponsor ID
- OPH0260
- Conditions
- Anesthesia, Local, Eyelid Diseases
- Keywords
- oculoplastic surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Study start
- 4 Jun 2019 (actual)
- Primary completion
- 30 Oct 2019 (estimated)
- Study completion
- 30 Nov 2019 (estimated)
- First posted
- 25 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical AnestheticTopical anaesthetic drops (proxymetacaine 0.5% and tetracaine 1%) applied | Drug | Transconjunctival anaesthetic, Transcutaneous anaesthetic |
| Transconjunctival anaestheticLocal anaesthetic (50/50 mixture of bupivacaine 0.5% / lidocaine 2% with adrenaline 1:200 000) administered to the eyelid via the transconjunctival route | Procedure or surgery | Transconjunctival anaesthetic |
| Transcutaneous anaestheticLocal anaesthetic (50/50 mixture of bupivacaine 0.5% / lidocaine 2% with adrenaline 1:200 000) administered to the eyelid via the transcutaneous route | Procedure or surgery | Transconjunctival anaesthetic, Transcutaneous anaesthetic |
| Patient comfort questionnaireThe patient will be asked to rate the level of pain during each local anaesthetic injection on a 0-10 scale | Other | Transconjunctival anaesthetic, Transcutaneous anaesthetic |
| Facial photographThe patient will have a photograph taken following the anaesthetic injections to document the presence or absence of bruising | Other | Transconjunctival anaesthetic, Transcutaneous anaesthetic |
| Eyelid surgeryEyelid surgery will be performed as per the plan from their preoperative appointment | Procedure or surgery | Transconjunctival anaesthetic, Transcutaneous anaesthetic |
Primary outcome
Pain during local anaesthetic administration
Time frame: During local anaesthetic administration (2-3 minutes)
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)
3 secondary outcomes
Requirement for additional anaesthetic
Time frame: During surgical procedure (up to 1 hour)
Bruising after local anaesthetic
Time frame: Immediately after local anaesthetic (2-5 minutes)
Other complications
Time frame: During anaesthetic administration, surgery, or up until the first postoperative visit (2-3 weeks later)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Derived from this study: PubMed 34117385Jawad 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.
- Individual participant dataSharing planned: No
Related trials for Anesthesia, Local
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Recruiting
Minimum Effective Local Anesthetic Volume for Ultrasound Guided Superior Trunk Block
Musculoskeletal Diseases or Conditions
RecruitingPhase 3
A Study of Changes to Prostate Procedures
Prostate Cancer
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
We Fong Siah principal investigator
University Hospitals Southampton NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical Anesthetic, Transconjunctival anaesthetic and Transcutaneous anaesthetic in people with Anesthesia, Local and Eyelid Diseases, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact We Fong Siah (0044 23 8120 4761, we.siah@uhs.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain during local anaesthetic administration (time frame: During local anaesthetic administration (2-3 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04102878, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2019.