Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Full-strength lidocaine with epinephrine |
|
| Experimental | Experimental | Dilute lidocaine with epinephrine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Full strength lidocaine with epinephrine | Drug | 2% lidocaine with epinephrine 1:100,000 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Immediately after injection |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Immediately after surgery |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Timothy Ekhlassi, MD | Fraser Valley Cataract and Laser | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fraser Valley Cataract and Laser | Surrey | British Columbia | V3S5K7 | Canada |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Dilute lidocaine with epinephrine |
| Drug |
2% lidocaine with epinephrine 1:100,000 diluted with normal saline (09.% NaCl) in a 1:4 ratio |
|
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 24, 2025 | Dec 3, 2025 | 2 |
| ID | Term |
|---|---|
| D003483 | Cutis Laxa |
| D010146 | Pain |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D004837 | Epinephrine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
Not provided
Not provided