Intravenous (IV) Lidocaine for Opioid-refractory Pain
Primary Purpose
Neoplasms, Pain
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Lidocaine
Sponsored by
About this trial
This is an interventional treatment trial for Neoplasms focused on measuring Cancer, Pain, Lidocaine
Eligibility Criteria
Inclusion Criteria 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 Exclusion Criteria 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
Sites / Locations
- San Diego Hospice & Palliative Care
Outcomes
Primary Outcome Measures
Comparison of current pain scores before and after the 30 minute randomized intervention
Secondary Outcome Measures
Preliminary assessment of the safety of intravenous lidocaine
Identify parameters that positively or negatively predict response to lidocaine
Full Information
NCT ID
NCT00321347
First Posted
May 1, 2006
Last Updated
June 21, 2012
Sponsor
San Diego Hospice & Palliative Care
1. Study Identification
Unique Protocol Identification Number
NCT00321347
Brief Title
Intravenous (IV) Lidocaine for Opioid-refractory Pain
Official Title
A Randomized, Placebo Controlled Phase II Study of Parenteral Lidocaine's Ability To Acutely Relieve Opioid Refractory Pain
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Withdrawn
Why Stopped
No patients enrolled and clinician no longer at institution.
Study Start Date
May 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2009 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
San Diego Hospice & Palliative Care
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Pain is a pervasive symptom among advanced cancer patients. In addition to pain's negative impact, unrelieved pain is linked to depression and precludes patients from dealing with other aspects of life. The World Health Organization 3-step hierarchy for pain management is effective in controlling cancer pain in 70-90% of patients. However, a significant fraction of cancer patients continue to suffer from severe pain despite high dose opioid therapy. This opioid-refractory pain requires adjunctive pain medications. Often multiple adjunctive agents are needed concurrently to optimally control opioid-refractory pain. Unfortunately, patients remain in pain during the time needed to titrate these agents, and some patients don't have this time before their death. Clinically, there exists no widely available, acute intervention to quickly control opioid-refractory pain. Intraspinal delivery of medications, peripheral nerve blocks, and neurolysis help only the subset with well-localized pain syndromes, are invasive, and require subspecialty skills. Sedation quickly relieves pain but robs a patient of the ability to interact. The hypothesis to be tested in this study is that intravenous (IV) lidocaine can acutely palliate opioid-refractory pain. IV lidocaine has been shown to be effective in small trials in non-cancer patients with conditions such as post-herpetic neuralgia and diabetic neuropathy. Additionally, there are case reports of the efficacy of IV lidocaine in cancer patients with opioid-refractory pain. However, there are no randomized, placebo-controlled trials in cancer patients establishing efficacy. Moreover, because of lidocaine's pro-arrhythmic potential and relatively narrow therapeutic window, there is a theoretical risk of harm. As a practical matter of fact, IV lidocaine is not available for the vast majority of cancer patients in the US. To illuminate this situation, a double-blind, randomized, placebo-controlled, study will be conducted to determine the efficacy of IV lidocaine in acutely relieving severe opioid-refractory pain in advanced cancer patients. Secondary end-points include analyses of safety and clinical parameters predictive of lidocaine response. The expected outcome is that lidocaine will acutely, effectively, and safely relieve opioid-refractory pain. This outcome will significantly add to the evidence-based clinical armamentarium available to treat opioid-refractory pain and will significantly improve cancer patients' quality of life.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms, Pain
Keywords
Cancer, Pain, Lidocaine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Primary Outcome Measure Information:
Title
Comparison of current pain scores before and after the 30 minute randomized intervention
Secondary Outcome Measure Information:
Title
Preliminary assessment of the safety of intravenous lidocaine
Title
Identify parameters that positively or negatively predict response to lidocaine
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
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
Exclusion Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jay R Thomas, MD PhD
Organizational Affiliation
San Diego Hospice & Palliative Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Diego Hospice & Palliative Care
City
San Diego
State/Province
California
ZIP/Postal Code
92103-1407
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Intravenous (IV) Lidocaine for Opioid-refractory Pain
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