Effect of IV Lidocaine Infusions on Pain

• ClinicalTrials.gov Identifier: NCT00725504
• Recruitment Status: Completed
• First Posted: July 30, 2008
• Results First Posted: April 17, 2017
• Last Update Posted: February 15, 2019
• Sponsor: Stanford University
• Information provided by (Responsible Party): Sean Mackey, Stanford University

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Pain
• Intervention: Drug: Intravenous lidocaine
• Enrollment: 71

Participant Flow

Recruitment Details	71 patients were recruited through the Stanford University Pain Management Center.
Pre-assignment Details	Individuals were assessed for neuropathic pain prior to enrollment. Those with co-morbid cardiac disease were excluded from the study.

Arm/Group Title	Lidocaine Infusion
Arm/Group Description	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
Period Title: Overall Study
Started	71
Completed	71
Not Completed	0

Baseline Characteristics

Arm/Group Title		Lidocaine Infusion
Arm/Group Description		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 Number of Baseline Participants		71
Baseline Analysis Population Description		Seventy-one patients with chronic neuropathic pain
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	71 participants
	<=18 years	1 1.4%
	Between 18 and 65 years	60 84.5%
	>=65 years	10 14.1%
Age, Continuous; Mean (Full Range); Unit of measure: Years
	Number Analyzed	71 participants
		47; (17 to 82)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	71 participants
	Female	32 45.1%
	Male	39 54.9%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	71 participants
		71

Outcome Measures

1. Primary Outcome

Title	Present Pain Intensity
Description	Present pain intensity was measured using the visual analog scale (VAS). This is scored between 0 (no pain) to 10 (worst possible pain).
Time Frame	Patients completed the VAS of present pain intensity immediately before and immediately after placebo and during each infusion level

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Baseline	Placebo	Lidocaine 3 µg/ml	Lidocaine 5 µg/ml
Arm/Group Description:	Each participant was tested at the zero infusion rate.	Each participant received a placebo-saline infusion.	Each participant received an intravenous infusion of 3 µg/ml of lidocaine.	Each participant received an intravenous infusion of 5 µg/ml of lidocaine.
Overall Number of Participants Analyzed	71	71	71	71
Mean (Standard Error); Unit of Measure: Units on a scale
	6.25 (0.23)	5.64 (0.24)	4.92 (0.27)	4.18 (0.28)

Adverse Events

Time Frame	Adverse event data were collected during the infusion period (approximately one hour) for each participant.
Adverse Event Reporting Description	The definitions for adverse event and serious adverse event did not differ from clinicaltrials.gov.
Arm/Group Title	Lidocaine Infusion
Arm/Group Description	Each participant will receive an intravenous infusion of lidocaine. Plasma concentrations will be increased gradually from 0-5 µg/ml.
All-Cause Mortality
	Lidocaine Infusion
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events
	Lidocaine Infusion
	Affected / at Risk (%)
Total	0/71 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Lidocaine Infusion
	Affected / at Risk (%)
Total	9/71 (12.68%)
General disorders
Transient central nervous system side effects *	9/71 (12.68%)
* Indicates events were collected by non-systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Sean Mackey, Chief, Division of Pain Medicine, Director, Stanford Systems Neuroscience and Pain Lab
• Organization: Stanford University
• Phone: (650) 498-6477
• EMail: smackey@pain.stanford.edu

• Responsible Party: Sean Mackey, Stanford University
• ClinicalTrials.gov Identifier: NCT00725504
• Other Study ID Numbers: SU-07072008-1232
• First Submitted: July 28, 2008
• First Posted: July 30, 2008
• Results First Submitted: March 4, 2017
• Results First Posted: April 17, 2017
• Last Update Posted: February 15, 2019