Evaluation effect of Intravenous Magnesium Sulfate on pain rate afterL4,L5,S1 lumbar spine surgeryin clinical trial

Studying the effects of intravenous magnesium sulfate on pain after lumbar disc surgery at L4, L5 and L5, S1

A controlled, double-blind, randomized, phase 3 clinical trial with parallel groups on 80 patients. The rand function of Excel software was used for randomization.

Patients referred to Imam Khomeini Hospital in Sari. Random allocation method will be used. In two intervention groups (receiving magnesium sulfate) and control (receiving normal saline). The blocking process is done with the Random allocation software. Also, the size of each block (4, 6, etc.) is determined by the software. In this design, blinding is done by a random double-blind method. In this way, the person evaluating the patient and the patient themselves do not know the groups to which the patient has been assigned.

Inclusion criteria: Confirmed diagnosis by physical examination, CT scan and MRI, patient willingness to participate in the study and informed consent, candidate for non-emergency discectomy surgery, people under 50 years of age, people with normal kidney function, people with no history of heart problems. Exclusion criteria: Patient unwillingness to participate in the study, emergency discectomy surgery, known allergy to one of the study drugs, use of narcotic analgesics up to 12 hours before the intervention

Intervention group: Magnesium sulfate is injected once, at a dose of 50 mg/kg body weight, half an hour before the operation, from Darupakhsh Company, made in Iran. Control group: Placebo: Normal saline is injected once, at a dose of 50 mg/kg body weight, half an hour before the operation, from Darupakhsh Company, made in Iran.

The primary outcome of the study was the severity of patients' pain and the amount of narcotics consumed.

Random allocation method will be used. To randomly allocate samples to two intervention groups (receiving magnesium sulfate) and control (receiving normal saline), the blocking method will be used. The blocking process is done with the Random allocation software. Also, the size of each block (4, 6, etc.) is determined by the software.

In this design, blinding is done in a double-blind randomization manner. In this way, the patient's assessor and the patient themselves do not know which groups the patient is assigned to. The SNOSE method will be used to conceal (blind) the randomization. This method is one of the common methods for concealing randomization. The interventions are provided to the anesthetist in sealed envelopes. The participants, the principal investigator, and the anesthetist in the neurosurgery room, who are usually responsible for caring for the patients, are unaware of the group allocation, which groups received which drugs, and the type of study.