Intravenous (IV) Lidocaine for Opioid-refractory Pain

June 21, 2012 updated by: Jay Thomas, San Diego Hospice & Palliative Care

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92103-1407
        • San Diego Hospice & Palliative Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Preliminary assessment of the safety of intravenous lidocaine
Identify parameters that positively or negatively predict response to lidocaine

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

San Diego Hospice & Palliative Care

Investigators

  • Principal Investigator: Jay R Thomas, MD PhD, San Diego Hospice & Palliative Care

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Study Completion (ANTICIPATED)

May 1, 2009

Study Registration Dates

First Submitted

May 1, 2006

First Submitted That Met QC Criteria

May 1, 2006

First Posted (ESTIMATE)

May 3, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

June 22, 2012

Last Update Submitted That Met QC Criteria

June 21, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPS-05-002-MI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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