Trial Outcomes & Findings for Determination of the Duration of Action of a Lidocaine and a Bupivacaine Digital Nerve Block in Human Volunteers (NCT NCT01508832)

NCT ID: NCT01508832

Last Updated: 2020-01-30

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 12 participants
• Primary outcome timeframe: 30 minutes prior and 240 minutes post intervention.
• Results posted on: 2020-01-30

Participant Flow

Volunteers recruited through local media source. Protocol consisted of a single study day in anesthesia research study space at the University of California San Francisco Parnassus campus.

Participant milestones

Measure	Lidocaine Block, Right Finger; Bupivacaine Block, Left Finger Lidocaine 1% digital nerve block (2cc), right finger; Bupivacaine 0.25% digital nerve block (2cc), left finger.	Lidocaine Block, Left Finger; Bupivacaine Block, Right Finger Lidocaine 1% digital nerve block (2cc), left finger; Bupivacaine 0.25% digital nerve block (2cc), right finger.
Overall Study STARTED	6	6
Overall Study COMPLETED	6	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Determination of the Duration of Action of a Lidocaine and a Bupivacaine Digital Nerve Block in Human Volunteers

Baseline characteristics by cohort

Measure	Lidocaine Block, Right Finger; Bupivacaine Block, Left Finger n=6 Participants Lidocaine 1% Digital Nerve Block (2 cc) , right finger. Bupivacaine 0.25% Digital Nerve Block (2 cc), left finger	Lidocaine Block, Left Finger; Bupivacaine Block, Right Finger n=6 Participants Lidocaine 1% Digital Block (2cc), left finger; Bupivacaine 0.25% Digital Block (2 cc), right finger.	Total n=12 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants	6 participants n=7 Participants	12 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 minutes prior and 240 minutes post intervention.

Population: The correspondingly-treated(lidocaine, bupivacaine) finger of all 12 study participants included in analysis for each arm/group

Outcome measures

Measure	Lidocaine n=12 Participants Lidocaine 1% digital nerve block (2cc) in one finger	Bupivacaine n=12 Participants Bupivacaine 0.25% digital nerve block (2cc) in one finger
The Change in the Average Finger Temperature From Baseline to Post-intervention.	-1.35 degrees centigrade Standard Error 0.71	0.93 degrees centigrade Standard Error 0.71

Adverse Events

Lidocaine

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Bupivacaine

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Lidocaine n=12 participants at risk Lidocaine digital block in right or left finger	Bupivacaine n=12 participants at risk Bupivacaine digital block right or left finger
Skin and subcutaneous tissue disorders Blister	8.3% 1/12 • Number of events 1 • 1 day	8.3% 1/12 • Number of events 1 • 1 day

Additional Information

Ronald D Miller, MD

University of California San Francisco

Phone: 415 476-9034

Email: millerr@anesthesia.ucsf.edu

Results disclosure agreements

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