Trial Outcomes & Findings for Effect of IV Lidocaine Infusions on Pain (NCT NCT00725504)

Results Overview

Present pain intensity was measured using the visual analog scale (VAS). This is scored between 0 (no pain) to 10 (worst possible pain).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

71 participants

Primary outcome timeframe

Patients completed the VAS of present pain intensity immediately before and immediately after placebo and during each infusion level

Results posted on

2019-02-15

71 patients were recruited through the Stanford University Pain Management Center.

Individuals were assessed for neuropathic pain prior to enrollment. Those with co-morbid cardiac disease were excluded from the study.

Participant milestones
Measure	Lidocaine Infusion Each participant will receive an intravenous infusion of lidocaine. Plasma concentrations will be increased gradually from 0-5 ug/ml. Intravenous lidocaine: Intravenous lidocaine administered during fMRI scan at a maximum dose of 3mcg/ml
Overall Study STARTED	71
Overall Study COMPLETED	71
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Effect of IV Lidocaine Infusions on Pain

Baseline characteristics by cohort
Measure	Lidocaine Infusion n=71 Participants Each participant will receive an intravenous infusion of lidocaine. Plasma concentrations will be increased gradually from 0-5 ug/ml. Intravenous lidocaine: Intravenous lidocaine administered during fMRI scan at a maximum dose of 3mcg/ml
Age, Categorical <=18 years	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	60 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants
Age, Continuous	47 years n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants
Sex: Female, Male Male	39 Participants n=5 Participants
Region of Enrollment United States	71 participants n=5 Participants

Timeframe: Patients completed the VAS of present pain intensity immediately before and immediately after placebo and during each infusion level

Present pain intensity was measured using the visual analog scale (VAS). This is scored between 0 (no pain) to 10 (worst possible pain).

Outcome measures
Measure	Baseline n=71 Participants Each participant was tested at the zero infusion rate.	Placebo n=71 Participants Each participant received a placebo-saline infusion.	Lidocaine 3 µg/ml n=71 Participants Each participant received an intravenous infusion of 3 µg/ml of lidocaine.	Lidocaine 5 µg/ml n=71 Participants Each participant received an intravenous infusion of 5 µg/ml of lidocaine.
Present Pain Intensity	6.25 Units on a scale Standard Error 0.23	5.64 Units on a scale Standard Error 0.24	4.92 Units on a scale Standard Error 0.27	4.18 Units on a scale Standard Error 0.28

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Lidocaine Infusion n=71 participants at risk Each participant will receive an intravenous infusion of lidocaine. Plasma concentrations will be increased gradually from 0-5 µg/ml.
General disorders Transient central nervous system side effects	12.7% 9/71 • Adverse event data were collected during the infusion period (approximately one hour) for each participant. The definitions for adverse event and serious adverse event did not differ from clinicaltrials.gov.

Stanford University

Phone: (650) 498-6477