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A Randomized, Placebo Controlled Phase II Study of Parenteral Lidocaine's Ability To Acutely Relieve Opioid Refractory Pain

Phase 2
18 Years
Not Enrolling
Neoplasms, Pain

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Trial Information

A Randomized, Placebo Controlled Phase II Study of Parenteral Lidocaine's Ability To Acutely Relieve Opioid Refractory Pain

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.

Inclusion 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
- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

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

Principal Investigator

Jay R Thomas, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

San Diego Hospice & Palliative Care


United States: Food and Drug Administration

Study ID:




Start Date:

May 2006

Completion Date:

May 2009

Related Keywords:

  • Neoplasms
  • Pain
  • Cancer
  • Pain
  • Lidocaine
  • Neoplasms
  • Pain, Intractable



San Diego Hospice & Palliative CareSan Diego, California  92103