Intravenous (IV) Lidocaine for Opioid-refractory Pain

This study has been withdrawn prior to enrollment.
(No patients enrolled and clinician no longer at institution.)
Sponsor:
Information provided by (Responsible Party):
Jay Thomas, San Diego Hospice & Palliative Care
ClinicalTrials.gov Identifier:
NCT00321347
First received: May 1, 2006
Last updated: June 21, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Neoplasms
Pain
Drug: Lidocaine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Placebo Controlled Phase II Study of Parenteral Lidocaine's Ability To Acutely Relieve Opioid Refractory Pain

Resource links provided by NLM:


Further study details as provided by San Diego Hospice & Palliative Care:

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

Enrollment: 0
Study Start Date: May 2006
Estimated Study Completion Date: May 2009
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00321347

Locations
United States, California
San Diego Hospice & Palliative Care
San Diego, California, United States, 92103-1407
Sponsors and Collaborators
San Diego Hospice & Palliative Care
Investigators
Principal Investigator: Jay R Thomas, MD PhD San Diego Hospice & Palliative Care
  More Information

No publications provided

Responsible Party: Jay Thomas, Principal Investigator, San Diego Hospice & Palliative Care
ClinicalTrials.gov Identifier: NCT00321347     History of Changes
Other Study ID Numbers: CPS-05-002-MI
Study First Received: May 1, 2006
Last Updated: June 21, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by San Diego Hospice & Palliative Care:
Cancer
Pain
Lidocaine

Additional relevant MeSH terms:
Pain, Intractable
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014