Anesthesia, Local, Eyelid Abscess, Eyelid Boil, Eyelid Bump, Eyelid Deformity, Eyelid Papilloma, Eyelid Tumor, Ophthalmology
Conditions
Keywords
Oculoplastics, Local Anesthesia, Eyelid Anesthesia, Periocular Anesthesia
Brief summary
The investigators aim to assess whether bacteriostatic saline provides the same level of anesthesia as traditional local anesthesia while reducing pain associated with medication infusion in minor eyelid procedures
Detailed description
Benzoyl alcohol is an aromatic alcohol that has been used in healthcare primarily as an antibacterial preservative agent in bacteriostatic saline. It has also been shown to have anesthetic properties, and has been demonstrated to cause less pain with infusion compared to lidocaine, while maintaining adequate pain relief. The use of bacteriostatic saline alone as an anesthetic for incisional procedures in the periocular area has not yet been studied. The purpose of this study was to determine whether bacteriostatic saline provides an adequate level of anesthesia for minor in-office eyelid procedures while allowing for reducing pain associated with medication infusion compared with traditional local anesthetic agents. To assess this, the investigators will recruit 150 patients aged 18 or older undergoing minor eyelid procedures including eyelid biopsies, chalazion removal from outpatient oculoplastics clinics at University of California, San Francisco. Patients will be randomized in a 1:1 fashion to undergo local anesthetic with either 1% lidocaine with 1:100,000 epinephrine or 0.9% bacteriostatic saline. Primary outcome measure will be pain level on a scale of 1-10 with regards to injection and procedure itself. These will be compared between the two groups. The investigators hypothesize that bacteriostatic saline is superior to lidocaine with epinephrine in terms of pain with injection, but will result in a similar pain level during the procedure.
Interventions
DRUG0.9% Bacteriostatic Local Anesthetic Injection
Following research and procedural consent, local anesthetic injection will be carried out using a standard 1 cc of local anesthetic corresponding to the study arm (0.9% bacteriostatic saline or 1% lidocaine with 1:100,000 epinephrine). Prior to anesthetic administration, the procedure site will be cleaned using standard measures. A 30 gauge needle on a 3 centimeter cubed volume syringe will be utilized. Five minutes will be given for local anesthetic to take effect.
DRUG1% Lidocaine with 1:100,000 epinephrine Local Anesthetic Injection
Following research and procedural consent, local anesthetic injection will be carried out using a standard 1 cc of local anesthetic consisting of a commercially available mixture of 1% lidocaine with 1:100,000 epinephrine. Prior to anesthetic administration, the procedure site will be cleaned using standard measures. A 30 gauge needle on a 3 centimeter cubed volume syringe will be utilized. Five minutes will be given for local anesthetic to take effect.
PROCEDUREEyelid Lesion Removal
Following anesthesia administration, patient will proceed with recommended eyelid lesion removal. The procedure site will be cleaned according to standard protocol, and standard technique for lesion removal will be performed, which will vary according to type of lesion but may involve use of Westcott scissors, forceps, #15 or #11 blades or other oculoplastics administration. The exact procedural details will be at the discretion of the surgeon.
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
Patient and provider performing procedure will be masked to local anesthesia type
Eligibility
Sex/Gender
ALL
Age
18 Years to 110 Years
Healthy volunteers
No
Inclusion criteria
1. Age \>=18 years old 2. Undergoing clinic-based periocular procedure
Exclusion criteria
1. Any other topical, oral or intravenous sedating medications given alongside procedure 2. Allergy to saline, lidocaine or epinephrine 3. Unable to provide consent due to cognitive impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain on Injection | 5 minutes | Pain on a scale of 0-10 during injection process (0 being no pain, 10 being worst pain ever experienced). These will be patient-reported verbally and recorded immediately after injection. |
| Pain of Procedure | 10 minutes | Pain on a scale of 0-10 during procedure (0 being no pain, 10 being worst pain ever experienced). These will be patient-reported verbally and recorded immediately after procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Lesions That Needed Additional Anesthesia to Complete Procedure | 10 minutes | Number of Lesions that Needed Additional Anesthesia to Complete Procedure |
| Bleeding Level | 10 minutes | Physician-assessed level of bleeding after procedure (mild, moderate, severe). These will be physician-reported verbally and recorded immediately after procedure. |
Countries
United States
Participant flow
Recruitment details
95 patients with 110 lesions were recruited. There were 103 encounters, creating duplicate patients in the two separate groups. The primary unit type analyzed was lesions. Participants had either 1, 2, or 3 lesions. Each lesion was randomized separately. Therefore, one participant could be part of both the bacteriostatic and lidocaine with epinephrine groups.
Participants by arm
| Arm | Count |
|---|---|
| Bacteriostatic Saline as Local Anesthesia Patients receiving bacteriostatic saline as local anesthesia for in-office minor eyelid procedures at University of California, San Francisco Medical Center, Oculoplastics department
0.9% Bacteriostatic Local Anesthetic Injection: Following research and procedural consent, local anesthetic injection will be carried out using a standard 1 cc of local anesthetic corresponding to the study arm (0.9% bacteriostatic saline or 1% lidocaine with 1:100,000 epinephrine). Prior to anesthetic administration, the procedure site will be cleaned using standard measures. A 30 gauge needle on a 3 centimeter cubed volume syringe will be utilized. Five minutes will be given for local anesthetic to take effect.
Eyelid Lesion Removal: Following anesthesia administration, patient will proceed with recommended eyelid lesion removal. The procedure site will be cleaned according to standard protocol, and standard technique for lesion removal will be performed, which will vary according to type of lesion but may involve use of Westcott scissors, forceps, #15 or #11 blades or other oculoplastics administration. The exact procedural details will be at the discretion of the surgeon. | 55 |
| Bacteriostatic Saline as Local Anesthesia Patients receiving bacteriostatic saline as local anesthesia for in-office minor eyelid procedures at University of California, San Francisco Medical Center, Oculoplastics department
0.9% Bacteriostatic Local Anesthetic Injection: Following research and procedural consent, local anesthetic injection will be carried out using a standard 1 cc of local anesthetic corresponding to the study arm (0.9% bacteriostatic saline or 1% lidocaine with 1:100,000 epinephrine). Prior to anesthetic administration, the procedure site will be cleaned using standard measures. A 30 gauge needle on a 3 centimeter cubed volume syringe will be utilized. Five minutes will be given for local anesthetic to take effect.
Eyelid Lesion Removal: Following anesthesia administration, patient will proceed with recommended eyelid lesion removal. The procedure site will be cleaned according to standard protocol, and standard technique for lesion removal will be performed, which will vary according to type of lesion but may involve use of Westcott scissors, forceps, #15 or #11 blades or other oculoplastics administration. The exact procedural details will be at the discretion of the surgeon. | 59 |
| Lidocaine With Epinephrine as Local Anesthesia Patients receiving lidocaine with epinephrine as local anesthesia for in-office minor eyelid procedures at University of California, San Francisco Medical Center, Oculoplastics department
1% Lidocaine with 1:100,000 epinephrine Local Anesthetic Injection: Following research and procedural consent, local anesthetic injection will be carried out using a standard 1 cc of local anesthetic consisting of a commercially available mixture of 1% lidocaine with 1:100,000 epinephrine. Prior to anesthetic administration, the procedure site will be cleaned using standard measures. A 30 gauge needle on a 3 centimeter cubed volume syringe will be utilized. Five minutes will be given for local anesthetic to take effect.
Eyelid Lesion Removal: Following anesthesia administration, patient will proceed with recommended eyelid lesion removal. The procedure site will be cleaned according to standard protocol, and standard technique for lesion removal will be performed, which will vary according to type of lesion but may involve use of Westcott scissors, forceps, #15 or #11 blades or other oculoplastics administration. The exact procedural details will be at the discretion of the surgeon. | 48 |
| Lidocaine With Epinephrine as Local Anesthesia Patients receiving lidocaine with epinephrine as local anesthesia for in-office minor eyelid procedures at University of California, San Francisco Medical Center, Oculoplastics department
1% Lidocaine with 1:100,000 epinephrine Local Anesthetic Injection: Following research and procedural consent, local anesthetic injection will be carried out using a standard 1 cc of local anesthetic consisting of a commercially available mixture of 1% lidocaine with 1:100,000 epinephrine. Prior to anesthetic administration, the procedure site will be cleaned using standard measures. A 30 gauge needle on a 3 centimeter cubed volume syringe will be utilized. Five minutes will be given for local anesthetic to take effect.
Eyelid Lesion Removal: Following anesthesia administration, patient will proceed with recommended eyelid lesion removal. The procedure site will be cleaned according to standard protocol, and standard technique for lesion removal will be performed, which will vary according to type of lesion but may involve use of Westcott scissors, forceps, #15 or #11 blades or other oculoplastics administration. The exact procedural details will be at the discretion of the surgeon. | 51 |
| Total | 213 |
Baseline characteristics
| Characteristic | Bacteriostatic Saline as Local Anesthesia | Lidocaine With Epinephrine as Local Anesthesia | Total |
|---|---|---|---|
| Age, Continuous Baseline Population by Population | 58.5 years STANDARD_DEVIATION 18.5 | 59.8 years STANDARD_DEVIATION 16.2 | 59.1 years STANDARD_DEVIATION 17.4 |
| Baseline Lesion Size | 3.2 Millimeters STANDARD_DEVIATION 3.3 | 3.7 Millimeters STANDARD_DEVIATION 3.7 | 3.5 Millimeters STANDARD_DEVIATION 3.5 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Gender Distribution Female | 42 Participants | 32 Participants | 74 Participants |
| Sex: Female, Male Gender Distribution Male | 13 Participants | 16 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 55 | 0 / 48 |
| other Total, other adverse events | 0 / 55 | 0 / 48 |
| serious Total, serious adverse events | 0 / 55 | 0 / 48 |
Outcome results
Primary
Pain of Procedure
Pain on a scale of 0-10 during procedure (0 being no pain, 10 being worst pain ever experienced). These will be patient-reported verbally and recorded immediately after procedure.
Time frame: 10 minutes
Population: Primary unit analyzed was lesions. Because each participant may have been randomized more than once, each participant may have more than one outcome. For this reason, outcome measures are expressed based on lesions rather than participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bacteriostatic Saline as Local Anesthesia | Pain of Procedure | 4.9 score on a scale | Standard Deviation 2.9 |
| Lidocaine With Epinephrine as Local Anesthesia | Pain of Procedure | 2.0 score on a scale | Standard Deviation 2.7 |
Primary
Pain on Injection
Pain on a scale of 0-10 during injection process (0 being no pain, 10 being worst pain ever experienced). These will be patient-reported verbally and recorded immediately after injection.
Time frame: 5 minutes
Population: Primary unit analyzed was lesions. Because each participant may have been randomized more than once, each participant may have more than one outcome. For this reason, outcome measures are expressed based on lesions rather than participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bacteriostatic Saline as Local Anesthesia | Pain on Injection | 2.8 score on a scale | Standard Deviation 2.4 |
| Lidocaine With Epinephrine as Local Anesthesia | Pain on Injection | 3.6 score on a scale | Standard Deviation 2.6 |
Secondary
Bleeding Level
Physician-assessed level of bleeding after procedure (mild, moderate, severe). These will be physician-reported verbally and recorded immediately after procedure.
Time frame: 10 minutes
Population: Primary unit analyzed was lesions. Because each participant may have been randomized more than once, each participant may have more than one outcome. For this reason, outcome measures are expressed based on lesions rather than participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bacteriostatic Saline as Local Anesthesia | Bleeding Level | Number of Lesions with Mild Bleeding | 29 Number of lesions |
| Bacteriostatic Saline as Local Anesthesia | Bleeding Level | Number of Lesions with Moderate Bleeding | 25 Number of lesions |
| Bacteriostatic Saline as Local Anesthesia | Bleeding Level | Number of Lesions with Severe Bleeding | 4 Number of lesions |
| Bacteriostatic Saline as Local Anesthesia | Bleeding Level | Number of Lesions with Unknown Bleeding Level | 1 Number of lesions |
| Lidocaine With Epinephrine as Local Anesthesia | Bleeding Level | Number of Lesions with Unknown Bleeding Level | 2 Number of lesions |
| Lidocaine With Epinephrine as Local Anesthesia | Bleeding Level | Number of Lesions with Mild Bleeding | 33 Number of lesions |
| Lidocaine With Epinephrine as Local Anesthesia | Bleeding Level | Number of Lesions with Severe Bleeding | 0 Number of lesions |
| Lidocaine With Epinephrine as Local Anesthesia | Bleeding Level | Number of Lesions with Moderate Bleeding | 16 Number of lesions |
Secondary
Number of Lesions That Needed Additional Anesthesia to Complete Procedure
Number of Lesions that Needed Additional Anesthesia to Complete Procedure
Time frame: 10 minutes
Population: Primary unit analyzed was lesions. Because each participant may have been randomized more than once, each participant may have more than one outcome. For this reason, outcome measures are expressed based on lesions rather than participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bacteriostatic Saline as Local Anesthesia | Number of Lesions That Needed Additional Anesthesia to Complete Procedure | 33 lesions |
| Lidocaine With Epinephrine as Local Anesthesia | Number of Lesions That Needed Additional Anesthesia to Complete Procedure | 5 lesions |