The effect of lidocaine spray in reducing ophthalmic neuralgia in patients with multiple sclerosis

Determining the effect of lidocaine spray in reducing ophthalmic neuralgia in patients with multiple sclerosis

Clinical trial, with parallel groups, randomized, double-blind, phase 2-3 on 76 patients, Random allocation software will be used for randomization.

Total sample is 76 people in 2 groups and it is from the clients to the clinics covered by the University of Medical Sciences in the city of Sari and randomly per week. The patients are randomly divided into 2 groups of control and placebo, and one group of lidocaine 10% and the other group of normal nasal spray. They use saline and do not need to be assimilated. After each course of treatment, they are evaluated in terms of the amount of pain reduction by visual analog scale. Participants will be instructed to take 2 puffs of the spray (equivalent to 0.2 mg) at the time of pain..Pain will be measured at 15 minutes, 2, 8 and 24 hours after the intervention in both target and placebo groups.

Inclusion criteria: Definite MS confirmed by MRI Confirmation of ophthalmic neuralgia without response to drug treatment Performing a lidocaine sensitivity test and proving the absence of lidocaine sensitivity The patient's willingness to participate in the study and obtain informed consent The patient's MS must be of the relapsing remitting type and must have been approved by a neurologist. Exclusion criteria: Occurrence of drug side effects Worsening of symptoms. Patient dissatisfaction More than three months have passed since the diagnosis of their disease and they have entered the chronic phase

People are randomly divided into two control and placebo groups, and one group uses 10% lidocaine and the other group uses normal saline nasal spray.

The intensity of the conflict؛ The intensity of the patient's pain؛ Pain-free time after each use.

All identified patients will be included in the study and there is no need to calculate the sample size. The total sample size in two groups is 76 people, which is due to the fact that people enter the treatment center on weekdays by accident. First, eligible patients are taken from the average admission unit and then they are randomly divided into two groups based on the number of eligible patients. This is because the size of the two groups is almost equal, while the sample size in each group is 34 people, after considering 10% attrition, 38 people in each group and a total of 76 people are selected. For random assignment Random Allocation software was used for two groups and they were selected in blocks of 8 and assigned to two study groups.

After selecting the samples, none of the samples will be aware of the randomization and the process of allocating groups. Patients enter the study numbers in order. Lidocaine and normal saline spray is in the same packaging and the color of both consumed is the same. The time of spray use is in the pain time and this will be explained to the participants to consume 2 puffs of spray (equivalent to 1.2 mg). The evaluation at all stages mentioned above is the student who is unaware of the drugs. In our study, the patient and the evaluation have been blinded. And the neurologist is aware of the prescription drug.