Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00321347
Status:
WITHDRAWN
Last Update Posted:
2012-06-22
First Post:
2006-05-01
Brief Title:
Intravenous IV Lidocaine for Opioid-refractory Pain
Sponsor:
San Diego Hospice Palliative Care
Organization:
San Diego Hospice Palliative Care
Study Overview
Official Title:
A Randomized Placebo Controlled Phase II Study of Parenteral Lidocaines Ability To Acutely Relieve Opioid Refractory Pain
Status:
WITHDRAWN
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No patients enrolled and clinician no longer at institution
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 pains 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 dont 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 lidocaines 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None