Lidocaine Infusion for Chronic Pain in Opioid Dependent Patients
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|ClinicalTrials.gov Identifier: NCT02219321|
Recruitment Status : Terminated (Lack of Funding)
First Posted : August 18, 2014
Results First Posted : March 25, 2020
Last Update Posted : March 25, 2020
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Prescription drug abuse represents a major healthcare problem, with treatment costs reaching billions of dollars annually in the United States alone. Today opioids are commonly prescribed for chronic non-cancer pain and are only partially effective for short-term pain relief. Whereas opioids are initially part of the solution for pain, it eventually often turns to be a problem in patient with chronic pain. Long-term treatment with opioids can be complicated by development of tolerance, dependency, addiction, abnormal pain sensitivity, hormonal changes, and immune modulation. Unfortunately, the chronic use of anti-inflammatory drugs is associated with a marked increase in adverse effects.
The purpose of this study is to determine whether systemic administration of lidocaine provides effective pain relief in opioid dependent chronic pain patients. Investigators intend to demonstrate that lidocaine infusion can improve pain relief and physical function in opioid dependent patients, thus improving compliance and patient satisfaction, which may potentially help wean patients off narcotics. The long-term goal of this proposal is to decrease opioid dependence in chronic pain patients by using lidocaine infusion.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain||Drug: Lidocaine infusion Drug: Saline infusion||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Lidocaine Infusion for Chronic Pain in Opioid Dependent Patients|
|Actual Study Start Date :||December 2014|
|Actual Primary Completion Date :||May 14, 2015|
|Actual Study Completion Date :||September 20, 2019|
Active Comparator: Lidocaine infusion
A continuous intravenous infusion of lidocaine
Drug: Lidocaine infusion
Lidocaine intravenous 2mg/kg initial bolus over 5 minutes followed by a continuous intravenous infusion of lidocaine at a rate of 2mg /kg /hour for 4 hours
Other Name: Intravenous lidocaine
Placebo Comparator: Saline infusion
A continuous intravenous infusion of saline
Drug: Saline infusion
A continuous intravenous infusion of saline at the same volume with lidocaine infusion for 4 hours
Other Name: Isotonic Sodium Chloride
- Intensity of Pain [ Time Frame: Immediately after continuous 4-hours Intravenous lidocaine infusion ]Visual Analog Pain Scores on a scale of 0 to 10 (0=no pain and 10=worst pain)
- Withdrawal Time (Seconds) [ Time Frame: Immediately after Lidocaine Infusion ]The time to withdraw at the Cold Pressor Task immediately after 4-hours intravenous continuous lidocaine infusion
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|Ages Eligible for Study:||18 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Age 18-65 years old -Patient currently on stable dose of opioids for more than six months period -
- Patients with Chronic uncontrolled neuropathic pain with documented pain score > or = 4 despite opioids
- Not currently abusing opioids or other illicit drugs as demonstrated by history and negative urine toxicology screen
- Patient agrees to come to all follow up visits at 1, 2, and 3 week following infusion
- Having baseline/screening EKG
- Individuals meeting DSM-V dependence criteria for alcohol, benzodiazepine, CNS stimulant, marijuana or other drug of abuse.
- Hepatic dysfunction as determined by history and physical or clinical significant lab.
- Cardiac arrhythmias including heart block and QT prolongation as determined by history or baseline EKG.
- Subject has inability to understand and cooperate with study procedures or provide informed consent.
- Subject has history of intolerance or allergic reaction to lidocaine.
- Subject has history of seizures.
- Raynaud's disease
- Renal impairment as determined by clinically significant labs.
Women of childbearing age who either have:
- A positive pregnancy test
- Unprotected heterosexual sex since their previous menses or;
- Not currently using and/or willing to use a medically approved form of contraception (e.g., birth control pill).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02219321
|United States, Texas|
|University of Texas Southwestern Medical Center|
|Dallas, Texas, United States, 75390-9068|
|Parkland Health Hospital System|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||Enas Kandil, MD||University of Texas Southwestern Medical Center|
|Responsible Party:||Enas Kandil, Asistant Professor, University of Texas Southwestern Medical Center|
|Other Study ID Numbers:||
|First Posted:||August 18, 2014 Key Record Dates|
|Results First Posted:||March 25, 2020|
|Last Update Posted:||March 25, 2020|
|Last Verified:||March 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
Pain, Opioid dependence, Lidocaine infusion
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action