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IRCT20180121038462N1 IRCT 2018-03-11 Iran University of Medical Sciences Comparison of two methods of Bupivacaine and Fentanyl injection in lower limb fracture surgeries Comparison of fractionated dose of Bupivacaine and Fentanyl versus bolus dose injection in spinal anesthesia in lower limb fracture surgeries 2016-04-08 anticipated 60 Complete https://irct.ir/trial/29087 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are assigned to two groups of intervention and control by choosing one of the envelopes, Blinding description: In this study, the patients and person who performs spinal injections are not blind to the blind study, and only researcher is blind to the study. In this way, the researcher is not present in the room at the time of injection of anesthetic drug. 3 Condition 1: Lower limb fracture surgery. Condition 2: Lower limb fracture surgery. Condition 3: Lower limb fracture surgery. Intervention 1: Intervention group: Patients in intervention group, will receive half dose of 15 milligram of Bupivacaine 0.5 % and 25 micro gram of Fentanyl at first, and after 45 seconds half the other drug will be injected. Intervention 2: Control group: Patients in control group, will receive bolus dose of 15 milligram of Bupivacaine 0.5 % and 25 micro gram of Fentanyl and then will be placed in supine position after 45 seconds. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is I have not yet decided on this.
public Qazale Khaef
Faculty of Medicine, Iran University of Medical Sciences, Hemat Highway next to Milad Tower
Tehran Iran (Islamic Republic of) 1449614535 +98 21 86701 khaef.gh@iums.ac.ir Iran University of Medical Sciences scientific Poya Derakhshan
Faculty of Medicine, Iran University of Medical Sciences, Hemat Highway next to Milad Tower
Tehran Iran (Islamic Republic of) 144961459535 +98 21 6535 2326 pooyaderakh@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Patients undergoing surgery for lower limb fractures Age 18 to 50 years old ASA 1 to 2 18 years 50 years Both Patients with absolute spinal anesthesia contraindication Refusal of the patient Localized sepsis Allergy to the anesthetic drugs Patient's inability to maintain position during the procedure Increase ICP Spinal relative contraindications such as myelopathy or peripheral neuropathy Spinal stenosis history of spinal surgery Multiple sclerosis Spina bifida Aortic thrombosis Hypovolemia Hereditary coagulopathies Thromboprofylaxis (ambulatory lung) Systemic infections Patients with a BMI greater than 35 Spinal deformities Patients who did not succeed in spinal anesthesia Patients whose length of operation is longer than their spinal anesthesia length s70-s79 S80-S89 S90-S99 Injuries to the hip and thigh Injuries to the knee and lower leg Injuries to the ankle and foot Treatment - Drugs Treatment - Drugs Intervention group: Patients in intervention group, will receive half dose of 15 milligram of Bupivacaine 0.5 % and 25 micro gram of Fentanyl at first, and after 45 seconds half the other drug will be injected. Control group: Patients in control group, will receive bolus dose of 15 milligram of Bupivacaine 0.5 % and 25 micro gram of Fentanyl and then will be placed in supine position after 45 seconds. Blood pressure. Timepoint: 24 hours after surgery. Method of measurement: Noninvasive Blood Pressure Amplifier (NIBP). Heart rate. Timepoint: 24 hours after surgery. Method of measurement: Electrocardiography. Pruritus. Timepoint: 24 hours after surgery. Method of measurement: Observation. Urinary retention. Timepoint: 24 hours after surgery. Method of measurement: Observation. Shivering. Timepoint: 24 hours after surgery. Method of measurement: Observatioon. Respiratory distress. Timepoint: 24 hours after surgery. Method of measurement: Clinical feature. Nausea. Timepoint: 24 hours after surgery. Method of measurement: Observation. Vomiting. Timepoint: 24 hours after surgery. Method of measurement: Observation. Onset of sensory block. Timepoint: After the injection of anesthetic drug. Method of measurement: Pinprick test. Onset of motor block. Timepoint: After the injection of anesthetic drug. Method of measurement: Modified bromage scale. Highest level of sensory block. Timepoint: After the injection of anesthetic drug. Method of measurement: Pinprick test. Duration of sensory block. Timepoint: After the injection of anesthetic drug. Method of measurement: Modified bromage scale. Duration of motor block. Timepoint: After the injection of anesthetic drug. Method of measurement: Pinprick test. Iran University of Medical Sciences Approved 2018-02-19 Ethics committee of Shahid Iran University of Medical Science Hemat Highway next to Milad Tower, Iran University of Medical Sciences, Faculty of Medicine Tehran Tehran Iran (Islamic Republic of)