Trial Outcomes & Findings for Effectiveness Study of Different Local Anesthetic Mixtures (NCT NCT01243112)

Results Overview

The time from onset of local anesthesia until cessation of effect by sensation of sharp measured in 15 minute increments.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

25 participants

Primary outcome timeframe

Up to 12 hours

Results posted on

2011-12-02

Participant Flow

Subjects were recruited by hospital mailing list with 25 subjects enrolled over May 2010 until September 2010.

Participant milestones

Participant milestones
Measure	Study Group 0.2 ml 1% Lidocaine with Epinephrine (1:100,000), 0.2 ml 0.25% Bupivacaine with Epinephrine (1:200,000) 0.2 ml 0.5% Lidocaine and 0.125% Bupivacaine with Epinephrine Epinephrine (1:150,000) 2 ml of 1% Lidocaine and 0.25% Bupivacaine with Epinephrine (1:150,000)
Overall Study STARTED	25
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effectiveness Study of Different Local Anesthetic Mixtures

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study Group n=25 Participants 0.2 ml 1% Lidocaine with Epinephrine (1:100,000), 0.2 ml 0.25% Bupivacaine with Epinephrine (1:200,000) 0.2 ml 0.5% Lidocaine and 0.125% Bupivacaine with Epinephrine Epinephrine (1:150,000) 2 ml of 1% Lidocaine and 0.25% Bupivacaine with Epinephrine (1:150,000)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	36 years STANDARD_DEVIATION 9.7 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 12 hours

Population: A calculation was made to power the study appropriately to determine a difference of 5 minutes based on previous studies which did not include the use of epinephrine.

The time from onset of local anesthesia until cessation of effect by sensation of sharp measured in 15 minute increments.

Outcome measures

Outcome measures
Measure	Study Group n=25 Participants 0.2 ml 1% Lidocaine with Epinephrine (1:100,000), 0.2 ml 0.25% Bupivacaine with Epinephrine (1:200,000) 0.2 ml 0.5% Lidocaine and 0.125% Bupivacaine with Epinephrine Epinephrine (1:150,000) 2 ml of 1% Lidocaine and 0.25% Bupivacaine with Epinephrine (1:150,000)
Length of Action 1% Lidocaine With Epinephrine	6.63 minutes Standard Deviation 1.85
Length of Action 0.25% Bupivacaine With Epinephrine	7.02 minutes Standard Deviation 1.46
Length of Action 0.5% Lidocaine and 0.125% Bupivacaine With Epineph	7.48 minutes Standard Deviation 1.76
Length of Action 1% Lidocaine and 0.25% Bupivacaine With Epinephrin	7.16 minutes Standard Deviation 1.60

PRIMARY outcome

Timeframe: Up to 5 minutes

Time from infusion of local anesthetic to loss of sensation to sharp.

Outcome measures

Outcome measures
Measure	Study Group n=25 Participants 0.2 ml 1% Lidocaine with Epinephrine (1:100,000), 0.2 ml 0.25% Bupivacaine with Epinephrine (1:200,000) 0.2 ml 0.5% Lidocaine and 0.125% Bupivacaine with Epinephrine Epinephrine (1:150,000) 2 ml of 1% Lidocaine and 0.25% Bupivacaine with Epinephrine (1:150,000)
Onset of Action 1% Lidocaine With Epinephrine	29 second Standard Deviation 49
Onset of Action 0.25% Bupivacaine With Epinephrine	19 second Standard Deviation 41
Onset of Action 0.5% Lidocaine and 0.125% Bupivacaine With Epineph	26 second Standard Deviation 46
Onset of Action 1% Lidocaine and 0.25% Bupivacaine With Epinephrin	12 second Standard Deviation 30

Adverse Events

Study Group

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

James Collins, MD

Scott & White Healthcare

Phone: 254-724-7508

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place