DermatochalasisPhase 4NCT06121141
Comparison of Two Different Concentrations of Local Anesthetic in Patient Reported Pain in Oculoplastic Surgery
A Phase 4 study testing Full strength lidocaine with epinephrine and Dilute lidocaine with epinephrine in people with Dermatochalasis and Dermatochalasis of Eyelid, run by Timothy Ekhlassi at 1 site in Canada.
Trial summary
The goal of this clinical trial is to compare pain scores in people undergoing upper eyelid surgery. The main questions it aims to answer are: Is one concentration of local anesthetic (also called numbing or freezing injection) less painful when it is injected? Does one concentration of local anesthetic provide better… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dermatochalasis, Dermatochalasis of Eyelid, Dermatochalasis of Both Upper Eyelids
- What is being tested?
- Full strength lidocaine with epinephrine and Dilute lidocaine with epinephrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 7 Aug 2023to 27 May 2024
- Phase
- Phase 4
- 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 age 18 and older undergoing primary bilateral upper eyelid blepharoplasty
- Consent and compliance with all aspects of the study protocol
Who cannot join
- Patients undergoing two different types of surgery on either side (example, blepharoplasty on one side and ptosis repair on the other)
- Patients under 18 years old
- Patient scheduled for upper eyelid blepharoplasty who has had previous upper eyelid ptosis repair or upper eyelid blepharoplasty
- Patient undergoing unilateral surgery
- Active local or systemic malignancy
- Concurrent inflammatory lesion of the upper eyelids
- Participant is pregnant or plans to become pregnant during the treatment period
- Participant is involved in a WorkSafe (worker's compensation), personal injury suit, or other legal matter related to their health
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to compare pain scores in people undergoing upper eyelid surgery. The main questions it aims to answer are:
- Is one concentration of local anesthetic (also called numbing or freezing injection) less painful when it is injected?
- Does one concentration of local anesthetic provide better pain control during surgery? Participants will have two different concentrations of local anesthetic injected into the upper eyelid skin prior to surgery, and will be asked to rate the pain they have during the injection. At the end of surgery, they will be asked to rate the pain they have during surgery.
Researchers will compare the pain scores to see if one of the concentrations is less painful during the injection and to see if one of the concentrations provides better pain control during surgery.
Read the detailed description
Purpose:
The purpose of this study is to evaluate the level of pain experienced during injection of dilute local anesthetic when compared to non-dilute local anesthetic for oculoplastic surgery. It will also evaluate the level of pain experienced during surgery when comparing dilute local anesthetic to non-dilute local anesthetic for oculoplastic surgery.
Study design:
Randomized, double-blind study of 30 patients undergoing elective bilateral upper eyelid blepharoplasty, for a total of 60 eyes having surgery. For each patient, one side will be injected using the control medication consisting of non-dilute 2% lidocaine with epinephrine 1:100,000, and the other side will be injected using the treatment medication consisting of 2% lidocaine with epinephrine 1:100,000 diluted with normal saline (09.% NaCl) in a 1:4 ratio with normal saline (1 cc of anesthetic to 4 cc of normal saline). The distribution of which eyelid (right versus left) receives each arm will be randomized and hidden from both the researcher and the patient. Identical syringes and hypodermic needles will be used for the treatment and control arms. Each patient will then be asked to rate the pain experienced during local anesthetic injection for each side using a 100 mm visual analog scale (VAS). At the end of surgery, each patient will be asked to rate the level of pain experienced during the surgery on each side using a blank version of the same scale. Patients will be followed up for their regular post-operative appointment 7-21 days after surgery.
Data (VAS pain scores) will be collected on paper from each patient and entered into an Excel format spreadsheet. The need for additional local anesthetic, as well as the rate of anesthetic infiltration, will also be recorded in this Excel file. All data will be deidentified by assigning each participant an alphanumeric code.
- Conditions
- Dermatochalasis, Dermatochalasis of Eyelid, Dermatochalasis of Both Upper Eyelids, Dermatochalasis of Both Eyes, Dermatochalasis of Right Upper Eyelid, Dermatochalasis of Left Upper Eyelid
- Being tested
- Full strength lidocaine with epinephrine, Dilute lidocaine with epinephrine
- Keywords
- Dermatochalasis, Oculoplastic surgery, Eyelid surgery, Blepharoplasty, Upper blepharoplasty, Upper eyelid blepharoplasty
- Medical subject headings
- Cutis Laxa, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full strength lidocaine with epinephrineDrug
2% lidocaine with epinephrine 1:100,000
Dilute lidocaine with epinephrineDrug
2% lidocaine with epinephrine 1:100,000 diluted with normal saline (09.% NaCl) in a 1:4 ratio
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Full-strength lidocaine with epinephrine Receives: Drug: Full strength lidocaine with epinephrine |
| Experimental | Experimental | Dilute lidocaine with epinephrine Receives: Drug: Dilute lidocaine with epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain during injection
Each patient will be asked to rate the pain experienced during local anesthetic injection for each side using a 100 mm visual analog scale (VAS)
Measured: Immediately after injection
Secondary outcomes (1)
Pain during surgery
Each patient will be asked to rate the pain experienced during surgery for each side using a 100 mm visual analog scale (VAS)
Measured: Immediately after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start7 Aug 2023
- Primary completion23 Jan 2024
- Study completion27 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DermatochalasisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Timothy Ekhlassi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Timothy Ekhlassi, Ekhlassi, Timothy, MD
- Investigators
- Timothy Ekhlassi, MD, Principal investigator, Fraser Valley Cataract and Laser
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06121141
- Sponsor's protocol ID
- Thesis001
- Status last verified
- Sep 2024
- First submitted
- 2 Nov 2023
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Different Concentrations of Local Anesthetic in Patient Reported Pain in Oculoplastic Surgery
- ClinicalTrials.gov ID
- NCT06121141
- Acronym / sponsor ID
- Thesis001
- Conditions
- Dermatochalasis, Dermatochalasis of Eyelid, Dermatochalasis of Both Upper Eyelids, Dermatochalasis of Both Eyes, Dermatochalasis of Right Upper Eyelid, Dermatochalasis of Left Upper Eyelid
- Keywords
- Dermatochalasis, Oculoplastic surgery, Eyelid surgery, Blepharoplasty, Upper blepharoplasty, Upper eyelid blepharoplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Timothy EkhlassiUniversity, hospital or other
- Study start
- 7 Aug 2023 (actual)
- Primary completion
- 23 Jan 2024 (actual)
- Study completion
- 27 May 2024 (actual)
- First posted
- 7 Nov 2023 (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.
The goal of this clinical trial is to compare pain scores in people undergoing upper eyelid surgery. The main questions it aims to answer are:
- Is one concentration of local anesthetic (also called numbing or freezing injection) less painful when it is injected?
- Does one concentration of local anesthetic provide better pain control during surgery? Participants will have two different concentrations of local anesthetic injected into the upper eyelid skin prior to surgery, and will be asked to rate the pain they have during the injection. At the end of surgery, they will be asked to rate the pain they have during surgery.
Researchers will compare the pain scores to see if one of the concentrations is less painful during the injection and to see if one of the concentrations provides better pain control during surgery.
Detailed description
Purpose:
The purpose of this study is to evaluate the level of pain experienced during injection of dilute local anesthetic when compared to non-dilute local anesthetic for oculoplastic surgery. It will also evaluate the level of pain experienced during surgery when comparing dilute local anesthetic to non-dilute local anesthetic for oculoplastic surgery.
Study design:
Randomized, double-blind study of 30 patients undergoing elective bilateral upper eyelid blepharoplasty, for a total of 60 eyes having surgery. For each patient, one side will be injected using the control medication consisting of non-dilute 2% lidocaine with epinephrine 1:100,000, and the other side will be injected using the treatment medication consisting of 2% lidocaine with epinephrine 1:100,000 diluted with normal saline (09.% NaCl) in a 1:4 ratio with normal saline (1 cc of anesthetic to 4 cc of normal saline). The distribution of which eyelid (right versus left) receives each arm will be randomized and hidden from both the researcher and the patient. Identical syringes and hypodermic needles will be used for the treatment and control arms. Each patient will then be asked to rate the pain experienced during local anesthetic injection for each side using a 100 mm visual analog scale (VAS). At the end of surgery, each patient will be asked to rate the level of pain experienced during the surgery on each side using a blank version of the same scale. Patients will be followed up for their regular post-operative appointment 7-21 days after surgery.
Data (VAS pain scores) will be collected on paper from each patient and entered into an Excel format spreadsheet. The need for additional local anesthetic, as well as the rate of anesthetic infiltration, will also be recorded in this Excel file. All data will be deidentified by assigning each participant an alphanumeric code.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: Full strength lidocaine with epinephrineFull-strength lidocaine with epinephrine |
| Experimental | Experimental | Drug: Dilute lidocaine with epinephrineDilute lidocaine with epinephrine |
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 age 18 and older undergoing primary bilateral upper eyelid blepharoplasty
- Consent and compliance with all aspects of the study protocol
Key exclusion criteria (8 listed)
- Patients undergoing two different types of surgery on either side (example, blepharoplasty on one side and ptosis repair on the other)
- Patients under 18 years old
- Patient scheduled for upper eyelid blepharoplasty who has had previous upper eyelid ptosis repair or upper eyelid blepharoplasty
- Patient undergoing unilateral surgery
- Active local or systemic malignancy
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 |
|---|---|---|
| Full strength lidocaine with epinephrine2% lidocaine with epinephrine 1:100,000 | Drug | Control |
| Dilute lidocaine with epinephrine2% lidocaine with epinephrine 1:100,000 diluted with normal saline (09.% NaCl) in a 1:4 ratio | Drug | Experimental |
Primary outcome
Pain during injection
Time frame: Immediately after injection
Each patient will be asked to rate the pain experienced during local anesthetic injection for each side using a 100 mm visual analog scale (VAS)
1 secondary outcome
Pain during surgery
Time frame: Immediately after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Timothy Ekhlassi, MD principal investigator
Fraser Valley Cataract and Laser
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Full strength lidocaine with epinephrine and Dilute lidocaine with epinephrine in people with Dermatochalasis and Dermatochalasis of Eyelid, run by Timothy Ekhlassi at 1 site in Canada.
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 8 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: finished, as of the sponsor's last update on 20 Sep 2024. 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 Canada. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain during injection (time frame: Immediately after injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Sep 2024.