NCT00321347

Brief Summary

Opioid medicines, like morphine, are the main treatment for severe cancer pain. Unfortunately, some patients suffer severe pain despite high doses of opioids. We hypothesize that intravenous lidocaine can quickly and effectively treat this kind of opioid-refractory pain.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2006

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2006

Completed
Same day until next milestone

Study Start

First participant enrolled

May 1, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2006

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

June 22, 2012

Status Verified

June 1, 2012

First QC Date

May 1, 2006

Last Update Submit

June 21, 2012

Conditions

NeoplasmsPain

Keywords

CancerPainLidocaine

Outcome Measures

Primary Outcomes (1)

  • Comparison of current pain scores before and after the 30 minute randomized intervention

Secondary Outcomes (2)

  • Preliminary assessment of the safety of intravenous lidocaine

  • Identify parameters that positively or negatively predict response to lidocaine

Interventions

LidocaineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Advanced cancer patient (prognosis ≤6 mos)
  • Age ≥ 18 years old
  • Opioid-refractory pain
  • Steady state levels of adjunctive pain medications
  • Intravenous access
  • Has decision-making capacity
  • Hemodynamics: 85\<SBP\<210 mm Hg \& 55\<HR\<120
  • EKG QTc ≤ 440 msec

You may not qualify if:

  • Methadone use
  • Myoclonus
  • Seizure disorder
  • History of ventricular arrhythmia
  • Allergy to amide local anesthetics
  • Evidence of cardiac ischemia by history or EKG
  • Currently receiving a parenteral local anesthetic
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Diego Hospice & Palliative Care

San Diego, California, 92103-1407, United States

Location

MeSH Terms

Conditions

NeoplasmsPain

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Jay R Thomas, MD PhD

    San Diego Hospice & Palliative Care

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 1, 2006

First Posted

May 3, 2006

Study Start

May 1, 2006

Study Completion

May 1, 2009

Last Updated

June 22, 2012

Record last verified: 2012-06

Locations

US(1)