Compare the effect of clonidine and tizanidine in controlling pain after lumbar fusion surgery

Comparison of the effect of clonidine and tetizanidine on pain control after lumbar fusion surgery

Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 75 patients. Block permutated randomization was determined for randomization and also to hide the Concealment randomization process.

Patients undergoing lumbar fusion surgery referred to Imam Khomeini Medical Center in Sari were randomly selected by block method (Block permutated randomization). The intervention is not known. In order to hide the randomization process of Concealment, after randomization of patients, the drugs were placed in envelopes with specific numbers. The anesthesia nurse was given to the patients in the recovery who did not know the contents of the envelopes.

Patients undergoing lumbar fusion surgery referred to Imam Khomeini Medical Center in Sari 1- Confirmation of diagnosis by physical examination, CT scan MRI 2- The patient's desire to participate in the study and gain informed consent 3- Candidate for non-emergency lumbar fusion surgery 4 - Age between 70- 35 years No history of allergy to tizanidine and clonidine Absence of bradycardia (HR <60) in patients 7- No CNS disease (including epilepsy and seizures)

Patients in the three groups, patients in group A, one 4 mg tizanidine tablet (manufactured by Galenus) orally and patients in group B, 4.0 mg clonidine (manufactured by company) Galen) and patients in group C will receive one placebo tablet orally one hour before surgery and 24 hours later.

Study of patients' pain intensity and drug use

Patients who met the inclusion criteria were determined using a computer program of random numbers by the method (Block permutated randomization) and also to hide the process of randomization Concealment after randomization of patients, drugs are placed in envelopes with specified numbers. These envelopes were given to patients at the time of administration by the anesthesia nurse in a recovery that did not know the contents of the envelopes. As a result, patients were randomly divided into three groups of 25 people A, B and C. Adequate explanations and training will be provided on how to determine the severity of pain, nausea, vomiting and itching after surgery using the VAS (Visual Analog Scale) criterion and how to use the PCA pump. According to the patients in the three groups, patients in group A received one 4 mg tizanidine tablet (manufactured by Galenus) orally and patients in group B received a 4.4 mg tablet. Gram clonidine (manufactured by Galenus) will be taken orally one hour before the operation and 24 hours later they will take one of these pills and patients in group C will be given one tablet in the same place as the placebo.

This study is double-blind and neither the patient nor the nurse of the project knows the type of intervention. Concealment randomization process After randomization of patients, the drugs were placed in envelopes with specific numbers, which were given to the patients when they were prescribed by the anesthesia nurse in the recovery, who did not know the contents of the envelopes.