| The Effect of Intravenous Lidocaine on Trigeminal Neuralgia: A Randomized Double Blind Placebo Controlled Trial |
| Design |
Randomized double blind placebo controlled crossover study
N= 20
|
| Objective |
To investigate in a prospective way the effect of lidocaine in patients with trigeminal neuralgia |
| Study Groups |
Lidocaine (n= 20)
Placebo (n= 20)
|
| Inclusion Criteria |
Confirmed diagnosis of TN according to IASP definition; age ≥18 years; VAS score ≥3; DN4 score ≥4; having received recommended medications for TN without therapeutic results; TN duration of at least 12 months; no history of allergy to lidocaine; no history of substance abuse; absence of severe psychiatric diseases; not pregnant; not lactating; absence of severe cardiac, hepatic, and renal disease; willing to provide written informed consent |
| Exclusion Criteria |
Not specified |
| Methods |
Each patient completed four sessions held every other day, receiving two lidocaine infusions and two placebo infusions in a randomized, double-blind, crossover design. Active treatment consisted of lidocaine 5 mg/kg in 250 mL of 5% dextrose infused over 1 hour, while placebo was 250 mL of 5% dextrose alone. Randomization was computer-generated, with one investigator preparing solutions and another, blinded to allocation, conducting examinations and administering infusions. Before and after each infusion, the blinded investigator recorded VAS pain scores and assessed mechanical, thermal, and cold allodynia as well as pinprick, heat, and cold hyperalgesia. Throughout the session, patients were continuously monitored with ECG, pulse oximetry, and blood pressure measurements, with vital signs documented every 15 minutes, and any adverse effects (e.g., somnolence, confusion, metallic taste, perioral tingling, visual disturbances, tremor) systematically recorded.
|
| Duration |
February 2007 to September 2011 |
| Outcome Measures |
Reduction in intensity of pain, allodynia, and hyperalgesia |
| Baseline Characteristics |
|
Study Population (n= 20) |
| Male sex (%) |
7 (35%) |
| Age, years |
65.20 ± 15.28 |
| Weight, kg |
73.75 ± 16.48 |
| Location of neuralgia - 1st trigeminal branch |
2 (10%) |
| Location of neuralgia - 2nd trigeminal branch |
2 (10%) |
| Location of neuralgia - 3rd trigeminal branch |
16 (80%) |
| DN4 score at baseline |
6.25 ± 0.63 |
| Abbreviations: DN4= Douleur Neuropathique 4 Questionnaire |
| Results |
|
Lidocaine (n= 40) |
Placebo (n= 40) |
p-value |
| VAS score post-treatment |
1.46 ± 1.37 |
3.33 ± 2.02 |
<0.001 |
| VAS score at 16:00 |
1.77 ± 1.61 |
4.08 ± 2.33 |
<0.001 |
| VAS score at 20:00 |
2.38 ± 1.73 |
4.45 ± 2.36 |
<0.001 |
| VAS score at 24:00 |
2.33 ± 1.84 |
4.43 ± 2.15 |
<0.001 |
| VAS score at 08:00 next morning |
2.95 ± 1.88 |
5.20 ± 2.55 |
<0.001 |
| VAS reduction % pre-/posttreatment |
76.4 ± 23.0 |
40.1 ± 31.9 |
<0.001 |
| Reduced mechanical allodynia |
31 (77.5%) |
20 (50.0%) |
0.011 |
| Reduced thermal allodynia |
18 (45.0%) |
7 (17.5%) |
0.008 |
| Reduced cold allodynia |
15 (37.5%) |
5 (12.5%) |
0.010 |
| Reduced pinprick hyperalgesia |
26 (65.0%) |
14 (35.0%) |
0.007 |
| Reduced hot hyperalgesia |
22 (55.0%) |
7 (17.5%) |
<0.001 |
| Reduced cold hyperalgesia |
20 (50.0%) |
11 (27.5%) |
0.039 |
| Abbreviations: VAS= visual analogue scale |
| Adverse Events |
No statistically significant changes in systolic BP, diastolic BP, HR, and oxygen saturation. Mild side effects reported more in lidocaine group: somnolence (32.5%), dry mouth (12.5%), dizziness (12.5%), headache (7.5%), feeling flushed (5%), confusion (2.5%), dysarthria (2.5%), tinnitus (2.5%)
|
| Study Author Conclusions |
Intravenous lidocaine is superior in reducing pain intensity, allodynia, and hyperalgesia compared to placebo, maintaining therapeutic results for 24 hours. It can be considered as an add-on treatment when first-line medications fail.
|
| Critique |
The study's crossover design is a strength, allowing each patient to serve as their own control, which is beneficial given the small sample size. However, the study is limited by its small sample size and the use of a single dose of lidocaine, which may not generalize to different dosages or larger populations. Future studies should explore varying dosages and larger sample sizes to confirm these findings.
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