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Lidocaine Infusion for Chronic Pain in Opioid Dependent Patients

NCT02219321 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2020-03-25

Study results available
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Summary

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.

Conditions

Interventions

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

DRUG

Saline infusion

A continuous intravenous infusion of saline at the same volume with lidocaine infusion for 4 hours

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Enas Kandil, MD · University of Texas Southwestern Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2015-05-14
Completion
2019-09-20

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02219321 on ClinicalTrials.gov