Clinical trial for comparison of effect of small dose of bupivacaine and sufentanil and normal dose of bupivacaine on hemodynamic variables in patients that underwent lower limb orthopedic surgery

Objectives: Clinical trial for comparison of effect of small dose of bupivacaine and sufentanil and normal dose of bupivacaine on hemodynamic variables in patients that will underwent lower limb orthopedic surgery. Design: all of patients that will candidate for lower limb orthopedic surgery randomly will divide to two groups, one group that will undergo spinal block with low dose of bupivacaine and sufentanil and another group that will undergo spinal block with normal dose of bupivacaine. The hemodaynamic, sensory and motor block variables will compare between two groups. Setting and conduct: 150 patients will identify in this clinical trial study for lower limb orthopedic surgery from 2009 till 2010. Our cases blindly will divide to two groups, group of case (n=75) and group of control (n=75) who will undergo spinal anesthesia. Participants including major eligibility criteria: Patients who will candidate for orthopedic lower limb surgery will include in our study. Patients with ASA class 3 and 4; and patients with contraindication for spinal anesthesia such as hemodynamic instability; refuse from spinal anesthesia; infection in site of spinal; raised CSF pressure and sensitivity to drugs will exclude from our study. Intervention: group one will undergo spinal block with 7.5 mg bupivacaine 0.5% and 5 µg sufentanil and group two will undergo spinal block with 15 mg bupivacaine 0.5%. Main outcome: Two groups will compare based on hypotension, need to use vasopressor, beginning of sensory block and its level and time of regression of the sensory level, pain during of surgery, duration of motor block, nausea, pruritus, vomiting and arrhythmia.

Vice chancellor for research, Hamedan University of Medical Sciences