Clinical Trial: Intravenous (IV) Lidocaine for Opioid-refractory Pain
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: A Randomized, Placebo Controlled Phase II Study of Parenteral Lidocaine's Ability To Acutely Relieve Opioid Refractory Pain
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 Summary: 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
Sponsor: San Diego Hospice & Palliative Care
Current Primary Outcome: Comparison of current pain scores before and after the 30 minute randomized intervention
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Preliminary assessment of the safety of intravenous lidocaine
- Identify parameters that positively or negatively predict response to lidocaine
Original Secondary Outcome: Same as current
Information By: San Diego Hospice & Palliative Care
Dates:
Date Received: May 1, 2006
Date Started: May 2006
Date Completion: May 2009
Last Updated: June 21, 2012
Last Verified: June 2012
