This randomized controlled, double blind study was done on 60 patients, who were ASA Class 1 or 2 and between the ages of 18 and 60. The patients were admitted to the trauma center of Poursina Hospital in Rasht, Iran. In addition, they were candidates for hand and forearm surgery. The duration of each surgery was less than 90 minutes. Consent was obtained from all patients. The variables of demographic features, onset time of the sensory and motor block, and the duration of sensory and motor block were answered in the questionnaire. The study was approved by the Ethical Committee of the Guilan University of Medical Sciences with ethical number 558.
Patients with a history of allergy to the drugs, cardio-vascular disorders, hypertension, coagulation abnormalities, excessive bleeding, Hb < 10, renal failure, skin infections around the axillae, opium addiction, pregnancy, or using beta blockers or calcium channel blockers were excluded from the study, as they are risk factors for high risk operations. It was shown that all blocks were perfect and all patients were suitable candidates for the procedure. Of the 60 patients, none were excluded.
Using randomization, 60 medical packets were prepared, mixed, and then given to the nurse in the operating room. Patients eligible to participate in this study and who had given written informed consent were referred to the operating room nurse who distributed one packet to each patient. The patients were introduced to the doctor and the nurse then discarded each packet. A total of 30 packets, named A, consisted of lidocaine plus magnesium sulfate and normal saline and the other 30 packets, named B, consisted of lidocaine plus normal saline. The nurse gave one of the closed envelopes to each patient and referred them to the doctor. After giving one packet to each patient, the nurse was not allowed to use it again.
Patients were thus randomly allocated into two groups. Group A received magnesium sulfate (5 mg/kg lidocaine plus 3 mL of 20 % magnesium sulfate and diluted in 40 mL of normal saline solution) and group B (control) received normal saline instead of magnesium sulfate (5 mg/kg lidocaine plus 3 mL of normal saline and diluted in 40 mL of normal saline solution). The dose of magnesium sulfate was calculated based on previous studies (
5-
7). The primary investigator prepared the pharmaceutical components. The anesthesiology resident, who did not know about the pharmaceutical composition, injected the drugs. The method of injection as well as the pinprick test and Bromage test were explained to all patients.
During surgery, ECG and oxygen saturation level were monitored with a Novin S 1800 machine (Pooyandegan Rahe Saadat). The patient’s arm on which the operation was performed was abducted to 90 degrees supine and flexed at the elbow joint to 90 degrees. The armpit was shaved and betadine was applied to the site as a topical antiseptic. The patients did not receive any sedatives before the axillary block. The axillary artery was palpated at a site situated in the proximal of axillae and the overlaying skin was anesthetized with 1 mL of 2 % lidocaine (Caspian Company, Iran). The axillary plexus block was performed under transarterial method and 20 mL of local anesthetic was injected posterior and 20 ml in anterior to the artery. The continuous aspiration and injection was taken to avoid intravascular injection. The musculocutaneous nerve was blocked by 5 mL of lidocaine 2% within the body of coracobrachialis muscle. The musculocutaneous nerve that provides sensory input for the lateral forearm also was blocked (in two groups). Sensory block level was monitored at one-minute intervals, as the onset of the nerve block is rapid. Sensory block level was performed by testing dermatomes of the sensory regions of the radial, median, and ulnar nerves. The intensity of the motor block was assessed using the modified Bromage scale at one-minute intervals as follows:
0) Unable to move fingers;
1) Able to move fingers only;
2) Able to bend wrist; and
3) Full flexion of the elbow.
When the sensory and motor blocks were fully established, the surgery was started. The sensory and motor blocks were assessed by the pinprick test and the modified Bromage test from the initiation of the blocks until the end of anesthesia. Such tests are safe and cause no damage. The end of sensory block was defined by have pain sensation during the pinprick test. At the end of motor block, the patient had pain sensation during the pinprick test in all sensate areas and the patient had complete movement of their body. All these tests were assessed in the recovery room. The operating time was 90 minutes or less and recovery time was approximately 30 minutes. After taking the patients to the recovery room, questionnaires of demographic features were completed. The duration of sensory and motor blocks were followed when the patients were in the recovery room. Sensory and motor responsiveness was tested at 10-minute intervals.
After inducing anesthesia in the patients, hemodynamic monitoring was performed. The patients who had blood pressure or pulse rate variability were excluded from the study as well as any patients who were not completely blocked 30 minutes after performing the infusion. After the sensory and motor block was established, patients reporting pain received an injection of 25 mg of pethidine and were excluded from the study. Patients who received IV drugs to control anxiety were also excluded from the study. In the study, no one had complications. Analysis was performed by descriptive statistics, the Chi-square test, and the t-test. Data was analyzed by the SPSS (version 16). A P value < 0.05 was considered statistically significant.