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IRCT201110097745N1 IRCT 2011-11-22 Vice chancellor for research Kerman University medical Sciences Spinal anesthesia with Lidocain Comparison duration of spinal anesthesia between Lidocain5% and Lidocain5% plus Epinephrine in chronic Opium addiction patients and non addiction patients in lower extremity orthopedic surgery 2010-07-27 anticipated 210 Complete https://irct.ir/trial/8192 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 2-3 Spinal anesthesia. Intervention 1: Addiction patients were selected according to our inclusion and exclusion criteria. All patients were visited the night before surgery and were informed about the study. In these patients were told to use their usual daily dose. All patients were NPO for 8 h before the scheduled surgical procedure. The anesthesiologist who performed the spinal anesthesia and documented the sensory level was blinded to the patient’s history of opium abuse. After standard monitoring (electrocardiogram, pulse oxymetry, noninvasive arterial blood pressure, and heart rate), the patients received 500–750 milliliter of lactated solution over 10–15min. Spinal anesthesia were performed with the patient in the sitting position under appropriate aseptic conditions. The L3–4 inter space was funded and with a 24-gauge Sprotte spinal needle was inserted via a midline approach. The needle bevel was oriented cephalic, while 75 milligrams of Lidocaine 5% with dextrose 7.5% was injected in some patients and 75 mg of Lidocaine 5% with dextrose 7.5% plus 0.2 milligrams Epinephrine was injected at a rate of 0.2 milliliter per second in other addicted patients. The patients were placed supine on surgical bed after drug injection. T6 level of sensory was achieved with the help of position maneuvers. Sensory level was assessed with pinprick flank of patient each 10 minute. The level of sensory was then checked and documented till sensory level received to T10. This time that decrease four level of sensory level was recorded and was based of our study. Intervention 2: Non Addiction patients were selected according to our inclusion and exclusion criteria. All patients were visited the night before surgery and were informed about the study. All patients were NPO for 8 h before the scheduled surgical procedure. The anesthesiologist who performed the spinal anesthesia and documented the sensory level was blinded to the patient’s history of opium non abuse. After standard monitoring (electrocardiogram, pulse oxymetry, noninvasive arterial blood pressure, and heart rate), the patients received 500–750 milliliter of lactated solution over 10-15min. Spinal anesthesia were performed with the patient in the sitting position under appropriate aseptic conditions. The L3–4 inter space was funded and with a 24-gauge Sprotte spinal needle was inserted via a midline approach. The needle bevel was oriented cephalic, while 75 milligrams of Lidocaine 5% with dextrose 7.5% was injected in some patients, and 75 milligrams of Lidocaine 5%with dextrose 7.5% plus 0.2 milligrams Epinephrine was injected at a rate of 0.2 milliliter per second in other non addicted patients. The patients were placed supine on surgical bed after drug injection. T6 level of sensory was achieved with the help of position maneuvers. Sensory level was assessed with pinprick flank of patient each 10 minute. The level of sensory was then checked and documented till sensory level received to T10. This time that decrease four level of sensory level was recorded and was based of our study.
public Afshin Mansourian
Bahonar Hospital, Baghe Meli Square، Kerman
Kerman Iran (Islamic Republic of) +98 34 1222 8034 Afshin.mansourian@yahoo.com Kerman University of medical sciences scientific Doctor Mohamad Askarzadeh
Neruscience research Center, BVL Jahad, Kerman
Kerman Iran (Islamic Republic of) +98 34 1222 8034 Alirezaaskarzadeh@yahoo.com Kerman university of medical Scienes Iran (Islamic Republic of) Exclusion criteria: 1 –patients with higher or lower then sixth lumbar vertebrae's primary sensory level of anesthesia 2- Individuals with BMI (Body Mass Index) more than 30 kg/m2 and less than 20 kg/m2 3- Alcohol abusers 4- Patients who refuse spinal anesthesia 5-patients with Less than one year of opium abusers in addicted group 6- Substance abuse in less than 2 last years for patients in non addicted group 7- Substance abusers other than opium 8- Patients who had developed neuropathy formerly or at present Inclusion criteria: 1- Fifteen to sixty five years old men with 150 to 180 centimeters in height 2- Drug addicted individuals with a history of more than one year abuse; specifically those who had shown withdrawal symptoms with abstention of drugs. 3- Patients who didn't use to any narcotic substances in less than 2 last years ** All information is based on the patient's statements. 15 years 65 years Male y48-3 Local anesthesia Treatment - Other Treatment - Drugs Addiction patients were selected according to our inclusion and exclusion criteria. All patients were visited the night before surgery and were informed about the study. In these patients were told to use their usual daily dose. All patients were NPO for 8 h before the scheduled surgical procedure. The anesthesiologist who performed the spinal anesthesia and documented the sensory level was blinded to the patient’s history of opium abuse. After standard monitoring (electrocardiogram, pulse oxymetry, noninvasive arterial blood pressure, and heart rate), the patients received 500–750 milliliter of lactated solution over 10–15min. Spinal anesthesia were performed with the patient in the sitting position under appropriate aseptic conditions. The L3–4 inter space was funded and with a 24-gauge Sprotte spinal needle was inserted via a midline approach. The needle bevel was oriented cephalic, while 75 milligrams of Lidocaine 5% with dextrose 7.5% was injected in some patients and 75 mg of Lidocaine 5% with dextrose 7.5% plus 0.2 milligrams Epinephrine was injected at a rate of 0.2 milliliter per second in other addicted patients. The patients were placed supine on surgical bed after drug injection. T6 level of sensory was achieved with the help of position maneuvers. Sensory level was assessed with pinprick flank of patient each 10 minute. The level of sensory was then checked and documented till sensory level received to T10. This time that decrease four level of sensory level was recorded and was based of our study Non Addiction patients were selected according to our inclusion and exclusion criteria. All patients were visited the night before surgery and were informed about the study. All patients were NPO for 8 h before the scheduled surgical procedure. The anesthesiologist who performed the spinal anesthesia and documented the sensory level was blinded to the patient’s history of opium non abuse. After standard monitoring (electrocardiogram, pulse oxymetry, noninvasive arterial blood pressure, and heart rate), the patients received 500–750 milliliter of lactated solution over 10-15min. Spinal anesthesia were performed with the patient in the sitting position under appropriate aseptic conditions. The L3–4 inter space was funded and with a 24-gauge Sprotte spinal needle was inserted via a midline approach. The needle bevel was oriented cephalic, while 75 milligrams of Lidocaine 5% with dextrose 7.5% was injected in some patients, and 75 milligrams of Lidocaine 5%with dextrose 7.5% plus 0.2 milligrams Epinephrine was injected at a rate of 0.2 milliliter per second in other non addicted patients. The patients were placed supine on surgical bed after drug injection. T6 level of sensory was achieved with the help of position maneuvers. Sensory level was assessed with pinprick flank of patient each 10 minute. The level of sensory was then checked and documented till sensory level received to T10. This time that decrease four level of sensory level was recorded and was based of our study Duration of spinal anesthesia with Lidocain%5. Timepoint: after 10 minute. Method of measurement: after 10 minute with pinprick on abdomen each 10 minute e %5. Height. Timepoint: At the time of admit ion. Method of measurement: by patient report. Age. Timepoint: At the time of admit ion. Method of measurement: by patient report. Body weight. Timepoint: At the time of admit ion. Method of measurement: by patient report. Vice chancellor for research Kerman University medical Sciences Approved 2011-05-25 Ethics committee of Kerman University of medical sciences BVL Jahad, Neuroscience Research Center of Kerman medical University kerman Iran (Islamic Republic of)