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IRCT2013070512958N3 IRCT 2014-04-02 Tehran University of Medical Sciences Duration of epidural anesthesia in opium addict patients Evaluation of epidural anesthesia blockade time with 0.5% bupivacaine, with or without Sufentanil, in opium addict patients in comparison with non-addicts: a randomized clinical trial 2013-03-19 anticipated 60 Complete https://irct.ir/trial/12940 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. N/A pain. Intervention 1: intervention group: On arrival in the operating room, standard monitoring was established (electrocardiography, noninvasive blood pressure, pulse oximetry and heart rate) and lactated ringer solution 7 ml. kg-1 was administered. Then, with the patient in the sitting position and using an aseptic technique, a 16-gauge Touhy needle was inserted via a midline approach into the L3–4 or L4–5 interspaces. Patients in group 1 received 80 mg of 0.5% hyperbaric bupivacaine along with 20 microgram sufentani. Intervention 2: control group: On arrival in the operating room, standard monitoring was established (electrocardiography, noninvasive blood pressure, pulse oximetry and heart rate) and lactated ringer solution 7 ml. kg-1 was administered. Then, with the patient in the sitting position and using an aseptic technique, a 16-gauge Touhy needle was inserted via a midline approach into the L3–4 or L4–5 interspaces. Patients in group 1 received 80 mg of 0.5% hyperbaric bupivacaine along with 1ml normal saline 0.9%. Intervention 3: intervention group: On arrival in the operating room, standard monitoring was established (electrocardiography, noninvasive blood pressure, pulse oximetry and heart rate) and lactated ringer solution 7 ml. kg-1 was administered. Then, with the patient in the sitting position and using an aseptic technique, a 16-gauge Touhy needle was inserted via a midline approach into the L3–4 or L4–5 interspaces. Patients in group 1 received 80 mg of 0.5% hyperbaric bupivacaine along with 20 microgram sufentani in opium addict patients. Intervention 4: intervention group: On arrival in the operating room, standard monitoring was established (electrocardiography, noninvasive blood pressure, pulse oximetry and heart rate) and lactated ringer solution 7 ml. kg-1 was administered. Then, with the patient in the sitting position and using an aseptic technique, a 16-gauge Touhy needle was inserted via a midline approach into the L3–4 or L4–5 interspaces. Patients in group 1 received 80 mg of 0.5% hyperbaric bupivacaine along with1ml normal saline 0.9% in opium addict patients.
public Yasaman Aghajani
Shariati Hosp, North Karegar Ave
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8490 2373 y-aghajani@razi.tums.ir Faculty of Medicine, Tehran University of Medical Sciences and Health Care scientific Ali Movafegh
Shariati Hosp, North Karegar Ave
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8490 2373 movafegh@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: 1.American Society of Anesthesiologist physical status (ASA) class I and II 2.lower limb orthopedic surgery under spinal anesthesia (lasting less than 3 hours) 3.any contraindications to epidural anesthesia 4.confirming the written consent 5. patients with addiction to any substance other than opium 6. male patients 7. patients aged between 20-50 years old Exclusion criteria: 1.patients with history of cardiac disease 2.patients with history of respiratory disease 3.patients with history of psychological disease 4. patients with history of allergic reaction to local anesthetics 5. orthopedic surgeries lasts more than 3 hours 20 years 50 years Male R52.0 acute pain Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs intervention group: On arrival in the operating room, standard monitoring was established (electrocardiography, noninvasive blood pressure, pulse oximetry and heart rate) and lactated ringer solution 7 ml. kg-1 was administered. Then, with the patient in the sitting position and using an aseptic technique, a 16-gauge Touhy needle was inserted via a midline approach into the L3–4 or L4–5 interspaces. Patients in group 1 received 80 mg of 0.5% hyperbaric bupivacaine along with 20 microgram sufentani control group: On arrival in the operating room, standard monitoring was established (electrocardiography, noninvasive blood pressure, pulse oximetry and heart rate) and lactated ringer solution 7 ml. kg-1 was administered. Then, with the patient in the sitting position and using an aseptic technique, a 16-gauge Touhy needle was inserted via a midline approach into the L3–4 or L4–5 interspaces. Patients in group 1 received 80 mg of 0.5% hyperbaric bupivacaine along with 1ml normal saline 0.9% intervention group: On arrival in the operating room, standard monitoring was established (electrocardiography, noninvasive blood pressure, pulse oximetry and heart rate) and lactated ringer solution 7 ml. kg-1 was administered. Then, with the patient in the sitting position and using an aseptic technique, a 16-gauge Touhy needle was inserted via a midline approach into the L3–4 or L4–5 interspaces. Patients in group 1 received 80 mg of 0.5% hyperbaric bupivacaine along with 20 microgram sufentani in opium addict patients intervention group: On arrival in the operating room, standard monitoring was established (electrocardiography, noninvasive blood pressure, pulse oximetry and heart rate) and lactated ringer solution 7 ml. kg-1 was administered. Then, with the patient in the sitting position and using an aseptic technique, a 16-gauge Touhy needle was inserted via a midline approach into the L3–4 or L4–5 interspaces. Patients in group 1 received 80 mg of 0.5% hyperbaric bupivacaine along with1ml normal saline 0.9% in opium addict patients Onset of sensory block. Timepoint: immediately after injection of the drug till surgical insicion. Method of measurement: chronometer. Duration of sensory block. Timepoint: incision till end of yhe surgery and start of postoperative pain. Method of measurement: chronometer. Duration of motor block. Timepoint: disable to move till enabling to move postoperative. Method of measurement: chronometer. Onset of motor block. Timepoint: disable to move from surgical incision. Method of measurement: chronometer. Surgery duration. Timepoint: during the operation. Method of measurement: chronometer. Intraoperative Fluid. Timepoint: during surgery. Method of measurement: Crystaloid Fluid registration chart. Tehran University of Medical Sciences Approved 2012-05-26 Ethics Committee, Faculty of Medicine Faculty of Medicine, Tehran University of Medical Sciences and Health Care Tehran Iran (Islamic Republic of)