Pain
Conditions
Keywords
lidocaine, allodynia, chronic regional pain syndrome, pain
Brief summary
The purpose of this study is to study if lidocaine, given intravenously, reduces pain.
Detailed description
Clinicians use lidocaine intravenously in a fashion that suggests that it might have analgesic effects. Therefore, we test the hypothesis that lidocaine reduces pain intensity in response to experimental pain.
Interventions
DRUGlidocaine
intravenous, effect site concentration: 2mcg/ml, 15-20 min infusion, once
Sponsors
American Society of Regional Anesthesia
University of Alabama at Birmingham
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Chronic Regional Pain Syndrome diagnostic criteria by the Work Safe BC. vi
Exclusion criteria
* History of Substance abuse * Other Medications: CRPS patients are expected to be treated for chronic pain, whether the current treatment regimen interferes with sensory motor testing will be determined on a case by case basis. * Coronary Artery Disease (CAD): unstable * Congestive Heart Failure (CHF): unstable * Heart Arrhythmia: symptomatic * Chronic Obstructive Pulmonary Disease (COPD) * Lidocaine Allergy * Diagnostic and Statistical Manual of Mental Disorders (Rev IV): Axis I: Common Axis I disorders include depression, anxiety disorders, bipolar disorder, ADHD, and schizophrenia. Axis II: borderline personality disorder, schizotypal personality disorder, antisocial personality disorder, and mild mental retardation. * Presence of Contraindications for MRI * Presence of electronically, magnetically, and mechanically activated implants * Electronically, magnetically, and mechanically activated implants * Ferromagnetic or electronically operated active devices like automatic cardioverter defibrillators * Cardiac pacemakers * Metallic splinters in the eye * Ferromagnetic haemostatic clips in the central nervous system (CNS) * Claustrophobia * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Perception | Participants will be followed from baseline through 128 minutes | Assessing heat pain perception (pain intensity) before, during, and after lidocaine infusion by means of patient self-report using a mechanical slide algometer. The mechanical slide algometer \[Price et al. (1994)\] looks like a ruler that exposes a red bar with the end-points: no pain (left) and most pain imaginable (right). The use the slider to express their perceived pain. On the back of the ruler a numerical scale ranging from 0 (no pain) to 10 (worst imaginable pain) translates the patient's rating into a numeric scale. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lidocaine Intravenous lidocaine for neuropathic pain
lidocaine: intravenous, effect site concentration: 2mcg/ml, 15-20 min infusion, once | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Lidocaine |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Pain Perception
Assessing heat pain perception (pain intensity) before, during, and after lidocaine infusion by means of patient self-report using a mechanical slide algometer. The mechanical slide algometer \[Price et al. (1994)\] looks like a ruler that exposes a red bar with the end-points: no pain (left) and most pain imaginable (right). The use the slider to express their perceived pain. On the back of the ruler a numerical scale ranging from 0 (no pain) to 10 (worst imaginable pain) translates the patient's rating into a numeric scale.
Time frame: Participants will be followed from baseline through 128 minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lidocaine | Pain Perception | Baseline | 5.40303 units on a scale | Standard Error 0.72232 |
| Lidocaine | Pain Perception | Infusion | 5.1457 units on a scale | Standard Error 0.7205 |
| Lidocaine | Pain Perception | After Infusion | 5.13171 units on a scale | Standard Error 0.72141 |