Trial Outcomes & Findings for Serum Concentration of Lidocaine After Local Injection During Mohs Micrographic Surgery (NCT NCT00793169)

Results Overview

Recruitment status

COMPLETED

Target enrollment

19 participants

Primary outcome timeframe

6 hours

Results posted on

2021-12-06

Participant Flow

Patients aged 18 years and older presenting to the university for Mohs micrographic surgery for removal of basal cell or cutaneous squamous cell carcinoma of the head and neck were eligible for enrollment.

Participant milestones

Participant milestones
Measure	Detectable Lidocaine Concentrations at Each Blood Draw The number of subjects with detectable serum lidocaine concentrations (\<0.1 ug/mL) at each blood draw.
Overall Study STARTED	19
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Serum Concentration of Lidocaine After Local Injection During Mohs Micrographic Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Detectable Lidocaine Concentrations at Each Blood Draw n=19 Participants The number of subjects with detectable serum lidocaine concentrations (\<0.1 ug/mL) at each blood draw.
Age, Continuous	60 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 hours

Population: Analysis was per protocol.

Outcome measures

Outcome measures
Measure	Detectable Lidocaine Concentrations at Each Blood Draw n=19 Participants The number of subjects with detectable serum lidocaine concentrations (\<0.1 ug/mL) at each blood draw.
The Number of Subjects With Detectable Serum Lidocaine Concentrations (<0.1 ug/mL) at Each Blood Draw. Blood Draw 4	2 Participants
The Number of Subjects With Detectable Serum Lidocaine Concentrations (<0.1 ug/mL) at Each Blood Draw. Blood Draw 1	0 Participants
The Number of Subjects With Detectable Serum Lidocaine Concentrations (<0.1 ug/mL) at Each Blood Draw. Blood Draw 2	1 Participants
The Number of Subjects With Detectable Serum Lidocaine Concentrations (<0.1 ug/mL) at Each Blood Draw. Blood Draw 3	0 Participants
The Number of Subjects With Detectable Serum Lidocaine Concentrations (<0.1 ug/mL) at Each Blood Draw. Blood Draw 5	1 Participants
The Number of Subjects With Detectable Serum Lidocaine Concentrations (<0.1 ug/mL) at Each Blood Draw. Blood Draw 6	5 Participants

Adverse Events

Detectable Lidocaine Concentrations at Each Blood Draw

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Detectable Lidocaine Concentrations at Each Blood Draw n=19 participants at risk The number of subjects with detectable serum lidocaine concentrations (\<0.1 ug/mL) at each blood draw.
Surgical and medical procedures Headache	5.3% 1/19 • Number of events 1 • 6 months
Surgical and medical procedures Shaky	5.3% 1/19 • Number of events 1 • 6 months

Additional Information

Murad Alam, MD

Northwestern University

Phone: 312-695-6785

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place