Effect of IV Lidocaine Infusions on Pain

NCT00725504 | Completed Results

• 1 other identifier: SU-07072008-1232
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

Our goals for this study involve using intravenous lidocaine as it is normally used in the Stanford Pain Management Center to assess the effect of intravenous lidocaine on chronic pain. Studies have been done determining the efficacy of intravenous lidocaine for treating pain but little research has been done to determine the effects of an intravenous lidocaine infusion on the different components of the pain experience. Our study will incorporate pain quality measures both before and during the infusions of lidocaine to determine changes in present pain intensity.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Present Pain Intensity

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

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

Study Arms (1)

Lidocaine infusion

EXPERIMENTAL

Each participant will receive an intravenous infusion of lidocaine. Plasma concentrations will be increased gradually from 0-5 µg/ml.

Drug: Intravenous lidocaine

Interventions

Intravenous lidocaine DRUG

Intravenous lidocaine administered up to 5 µg/ml.

Lidocaine infusion

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• meets the study criteria of chronic pain of either peripheral or central origin
• male or a non-pregnant, non-lactating female. If females are of reproductive potential (i.e., not surgically sterilized and/or not post menopausal), they must be practicing an accepted method of birth control, agree to a urine pregnancy test at the start of each study session (for patient scheduled through the clinic, this has already been addressed by the recommending physician)
• is not currently on a sodium channel blocking agent, anticonvulsant, or tricyclic antidepressant,
• must be able to comply with any other study requirements and complete experimental tasks

You may not qualify if:

• subject suffers from clinically significant cardiac, pulmonary, renal or liver disease;
• subject allergic to lidocaine.
• MRI Component: any metal objects (especially surgical clips), devices, or implants or any other MRI contraindication

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Sean Mackey, Chief, Division of Pain Medicine, Director, Stanford Systems Neuroscience and Pain Lab
• Organization: Stanford University

smackey@pain.stanford.edu

(650) 498-6477

Study Officials

• Sean Mackey

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 28, 2008
• First Posted: July 30, 2008
• Study Start: September 1, 2008
• Primary Completion: January 1, 2011
• Study Completion: February 1, 2011
• Last Updated: February 15, 2019
• Results First Posted: April 17, 2017

Record last verified: 2019-01

Locations

US (1)