Trial Outcomes & Findings for The Effect of Intravenous Lidocaine on Allodynia (NCT NCT00659633)

NCT ID: NCT00659633

Last Updated: 2017-07-21

Results Overview

Assessing heat pain perception (pain intensity) before, during, and after lidocaine infusion by means of patient self-report using a mechanical slide algometer. The mechanical slide algometer \[Price et al. (1994)\] looks like a ruler that exposes a red bar with the end-points: no pain (left) and most pain imaginable (right). The use the slider to express their perceived pain. On the back of the ruler a numerical scale ranging from 0 (no pain) to 10 (worst imaginable pain) translates the patient's rating into a numeric scale.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 10 participants
• Primary outcome timeframe: Participants will be followed from baseline through 128 minutes
• Results posted on: 2017-07-21

Participant Flow

Participant milestones

Measure	Lidocaine Intravenous lidocaine for neuropathic pain lidocaine: intravenous, effect site concentration: 2mcg/ml, 15-20 min infusion, once
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effect of Intravenous Lidocaine on Allodynia

Baseline characteristics by cohort

Measure	Lidocaine n=10 Participants Intravenous lidocaine for neuropathic pain lidocaine: intravenous, effect site concentration: 2mcg/ml, 15-20 min infusion, once
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants

PRIMARY outcome

Timeframe: Participants will be followed from baseline through 128 minutes

Assessing heat pain perception (pain intensity) before, during, and after lidocaine infusion by means of patient self-report using a mechanical slide algometer.

The mechanical slide algometer [Price et al. (1994)] looks like a ruler that exposes a red bar with the end-points: no pain (left) and most pain imaginable (right). The use the slider to express their perceived pain. On the back of the ruler a numerical scale ranging from 0 (no pain) to 10 (worst imaginable pain) translates the patient's rating into a numeric scale.

Outcome measures

Measure	Lidocaine n=10 Participants Intravenous lidocaine for neuropathic pain lidocaine: intravenous, effect site concentration: 2mcg/ml, 15-20 min infusion, once
Pain Perception Baseline	5.40303 units on a scale Standard Error 0.72232
Pain Perception Infusion	5.1457 units on a scale Standard Error 0.72050
Pain Perception After Infusion	5.13171 units on a scale Standard Error 0.72141

Adverse Events

Lidocaine

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

Dr. Michael Froelich

University of Alabama at Birmigham

Phone: 205-975-3328

Email: mfroelich@uabmc.edu

Results disclosure agreements

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