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Study aim
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Comparison of fractionated dose of Bupivacaine and Fentanyl versus bolus dose injection in spinal anesthesia in lower limb fracture surgery
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Design
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The present study will be conducted in a prospective single blind randomized controlled trial. This study will be performed on 60 patients aged 18-50 years with the American Society of Anesthesiologists (Physical Status) (ASA) 1-2, who were under the fractures of the lower limb surgery in Rasoul-e-Akram Hospital in 2016- 2017. Patients will be randomly divided into two groups using the closed envelopes they choose: Group A and Group B.
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Settings and conduct
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The present study will be conducted in Rasoul-e-Akram Hospital. Patients undergoing surgery for fracture of the lower limbs are randomly divided into two groups A and B. The spinal cord will be conducted at a sitting position at L3-L4 or L4-L5 levels using 23 gauge needles. Group A, will receive Fentanyl plus Bupivacaine, and patients position change to supine after 45 seconds. Group B, will receive half a dose of the drug (Fentanyl plus Bupivacaine) initially, and after another 45 seconds, half the other drug will be injected. In this study, the patient and person who performs spinal anesthesia are not blind to the study, and the researcher is the only person who is blind to the study and is not present in the room at the time of injection.
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Participants/Inclusion and exclusion criteria
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This prospective study is conducted on 60 patients with a range of 18-50 years old with ASA 1-2 which will undergo lower limb fractures surgeries in Rasoul-e-Akram Hospital in Tehran during 2016-2017. Patients with absolute spinal anesthesia contraindications such as refusal of the patient, localized sepsis, allergic to the anesthetic drugs, and the patient's inability to maintain position during the procedure, and to increase the ICP and spinal relative contraindications, patients with a BMI greater than 35 and deformities of the spine. Similarly, patients who did not succeed in spinal anesthesia or who have a longer surgical duration than their spinal anesthesia have undergone general anesthesia and are excluded.
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Intervention groups
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Group A, a bolus dose, receives 25 micrograms Fentanyl plus 15 milligrams of Bupivacaine 0.5%, and patients position change to supine after 45 seconds. Group B, half a dose of the drug (25 μg Fentanyl plus 15mg of Bupivacaine 0.5%) is initially injected, and after another 45 seconds, half the other drug will be injected.
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Main outcome variables
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Onset of sensory block, Onset of motor block, Highest level of sensory block, Duration of sensory block, Duration of motor block