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Effect of IV Lidocaine Infusions on Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
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
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
Hide 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
Arm/Group Title Lidocaine Infusion
Hide 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
Hide 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
1.Primary Outcome
Title Present Pain Intensity
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline Placebo Lidocaine 3 µg/ml Lidocaine 5 µg/ml
Hide 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)
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
Hide 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   --/-- 
Hide Serious Adverse Events
Lidocaine Infusion
Affected / at Risk (%)
Total   0/71 (0.00%) 
Hide 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
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
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
Layout table for additonal information
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