Trial Outcomes & Findings for Bacteriostatic Saline as a Local Anesthetic in Minor Eyelid Procedures (NCT NCT05294640)
NCT ID: NCT05294640
Last Updated: 2025-07-08
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
95 participants
Primary outcome timeframe
5 minutes
Results posted on
2025-07-08
Participant Flow
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.
Unit of analysis: Lesions
Participant milestones
| Measure |
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.
|
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.
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|---|---|---|
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Overall Study
STARTED
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55 59
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48 51
|
|
Overall Study
COMPLETED
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55 59
|
48 51
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Bacteriostatic Saline as Local Anesthesia
n=59 Lesions
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.
|
Lidocaine With Epinephrine as Local Anesthesia
n=51 Lesions
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.
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Total
n=110 Lesions
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
Baseline Population by Population
|
58.5 years
STANDARD_DEVIATION 18.5 • n=55 Participants
|
59.8 years
STANDARD_DEVIATION 16.2 • n=48 Participants
|
59.1 years
STANDARD_DEVIATION 17.4 • n=95 Participants
|
|
Sex: Female, Male
Gender Distribution · Female
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42 Participants
n=55 Participants
|
32 Participants
n=48 Participants
|
74 Participants
n=95 Participants
|
|
Sex: Female, Male
Gender Distribution · Male
|
13 Participants
n=55 Participants
|
16 Participants
n=48 Participants
|
29 Participants
n=95 Participants
|
|
Race and Ethnicity Not Collected
|
—
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—
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0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Baseline Lesion Size
|
3.2 Millimeters
STANDARD_DEVIATION 3.3 • n=59 Lesions
|
3.7 Millimeters
STANDARD_DEVIATION 3.7 • n=51 Lesions
|
3.5 Millimeters
STANDARD_DEVIATION 3.5 • n=110 Lesions
|
PRIMARY outcome
Timeframe: 5 minutesPopulation: 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.
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.
Outcome measures
| Measure |
Bacteriostatic Saline as Local Anesthesia
n=59 Lesions
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.
|
Lidocaine With Epinephrine as Local Anesthesia
n=51 Lesions
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.
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|---|---|---|
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Pain on Injection
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2.8 score on a scale
Standard Deviation 2.4
|
3.6 score on a scale
Standard Deviation 2.6
|
PRIMARY outcome
Timeframe: 10 minutesPopulation: 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.
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.
Outcome measures
| Measure |
Bacteriostatic Saline as Local Anesthesia
n=59 Lesions
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.
|
Lidocaine With Epinephrine as Local Anesthesia
n=51 Lesions
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.
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|---|---|---|
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Pain of Procedure
|
4.9 score on a scale
Standard Deviation 2.9
|
2.0 score on a scale
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: 10 minutesPopulation: 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.
Number of Lesions that Needed Additional Anesthesia to Complete Procedure
Outcome measures
| Measure |
Bacteriostatic Saline as Local Anesthesia
n=59 Lesions
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.
|
Lidocaine With Epinephrine as Local Anesthesia
n=51 Lesions
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.
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|---|---|---|
|
Number of Lesions That Needed Additional Anesthesia to Complete Procedure
|
33 lesions
|
5 lesions
|
SECONDARY outcome
Timeframe: 10 minutesPopulation: 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.
Physician-assessed level of bleeding after procedure (mild, moderate, severe). These will be physician-reported verbally and recorded immediately after procedure.
Outcome measures
| Measure |
Bacteriostatic Saline as Local Anesthesia
n=59 Lesions
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.
|
Lidocaine With Epinephrine as Local Anesthesia
n=51 Lesions
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.
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|---|---|---|
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Bleeding Level
Number of Lesions with Mild Bleeding
|
29 Number of lesions
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33 Number of lesions
|
|
Bleeding Level
Number of Lesions with Moderate Bleeding
|
25 Number of lesions
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16 Number of lesions
|
|
Bleeding Level
Number of Lesions with Severe Bleeding
|
4 Number of lesions
|
0 Number of lesions
|
|
Bleeding Level
Number of Lesions with Unknown Bleeding Level
|
1 Number of lesions
|
2 Number of lesions
|
Adverse Events
Bacteriostatic Saline as Local Anesthesia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Lidocaine With Epinephrine as Local Anesthesia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place