Trial Outcomes & Findings for Lidocaine Jelly for Pain Control During Mohs Surgery (NCT NCT03595449)

NCT ID: NCT03595449

Last Updated: 2021-07-13

Results Overview

The mean change of total pain score of patient perception of pain. As measured by the question "Rate the pain of your nose from 0 to 10. 0 being no pain, 10 being the worst pain of your life."

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 233 participants
• Primary outcome timeframe: baseline to stage 1 of Mohs surgery, approximately one hour
• Results posted on: 2021-07-13

Participant Flow

Participant milestones

Measure	Lidocaine Jelly This group had lidocaine jelly applied during Mohs surgery Lidocaine jelly: lidocaine 2% jelly applied during Mohs surgery	Surgilube This group had surgilube (placebo) applied during Mohs surgery Surgilube: surgilube (placebo) applied during Mohs surgery
Overall Study STARTED	118	115
Overall Study COMPLETED	118	115
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Lidocaine Jelly for Pain Control During Mohs Surgery

Baseline characteristics by cohort

Measure	Lidocaine Jelly n=118 Participants This group had lidocaine jelly applied during Mohs surgery Lidocaine jelly: lidocaine 2% jelly applied during Mohs surgery	Surgilube n=115 Participants This group had surgilube (placebo) applied during Mohs surgery Surgilube: surgilube (placebo) applied during Mohs surgery	Total n=233 Participants Total of all reporting groups
Age, Continuous	72.2 years STANDARD_DEVIATION 10.46 • n=5 Participants	71.7 years STANDARD_DEVIATION 11.38 • n=7 Participants	72.0 years STANDARD_DEVIATION 10.90 • n=5 Participants
Sex: Female, Male Female	44 Participants n=5 Participants	53 Participants n=7 Participants	97 Participants n=5 Participants
Sex: Female, Male Male	74 Participants n=5 Participants	62 Participants n=7 Participants	136 Participants n=5 Participants
Race/Ethnicity, Customized White	113 Participants n=5 Participants	109 Participants n=7 Participants	222 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Asian/Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment United States	118 participants n=5 Participants	115 participants n=7 Participants	233 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline to stage 1 of Mohs surgery, approximately one hour

The mean change of total pain score of patient perception of pain. As measured by the question "Rate the pain of your nose from 0 to 10. 0 being no pain, 10 being the worst pain of your life."

Outcome measures

Measure	Lidocaine Jelly n=118 Participants This group had lidocaine jelly applied during Mohs surgery Lidocaine jelly: lidocaine 2% jelly applied during Mohs surgery	Surgilube n=115 Participants This group had surgilube (placebo) applied during Mohs surgery Surgilube: surgilube (placebo) applied during Mohs surgery
Mean Change in Patient Perception of Pain Score	0.5 score on a scale Interval 0.2 to 0.8	0.3 score on a scale Interval 0.1 to 0.6

SECONDARY outcome

Timeframe: Through completion of Mohs surgery, approximately one day

Population: Data was not collected or analyzed for four subjects in each arm

The mean total amount of intervention used as measured by milligrams (mg)

Outcome measures

Measure	Lidocaine Jelly n=111 Participants This group had lidocaine jelly applied during Mohs surgery Lidocaine jelly: lidocaine 2% jelly applied during Mohs surgery	Surgilube n=114 Participants This group had surgilube (placebo) applied during Mohs surgery Surgilube: surgilube (placebo) applied during Mohs surgery
Mean Total Amount of Intervention (Lidocaine or Surgilube) Used	28.1 mg Standard Deviation 29.0	24.4 mg Standard Deviation 18.80

Adverse Events

Lidocaine Jelly

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Surgilube

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

Shari A. Ochoa, M.D.

Mayo Clinic

Phone: 480-301-6479

Email: Ochoa.Shari@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place