Heidari 2011.
Methods | RCT This study was approved by the Ethics Committee |
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Participants | Four hundred patients older than 30 years old (in class I, II, and III of ASA classification) who were scheduled for elective operative fixation of fractured hip Patients were included if they had no dementia or cognitive dysfunctions and no history of opioid or psychotic drugs use. Patients with hypersensitivity to blood transfusion, sever reaction to cement implantation, sever bleeding, hypotension needed interventions, prolonged operation changed surgical plan which impressed the study goals, were excluded 54.5% trochanteric 20.9% femoral neck 9.8% subtrochanteric Mean time of surgery > 72 hours after admission |
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Interventions |
Treatment group: patients were given Ringer's lactate solution (15 mL/kg) prior to the induction of anaesthesia and received either spinal with plain bupivacaine 0.5% (3 mL) at L3‐L4 or epidural anaesthesia with 25 mL of 0.5% bupivacaine with epinephrine 1:200,00 performed with a 18‐G‐Touhy needle at the L3‐L4 (n = 190) Control group: Patients were given Ringer's lactate solution (10 mL/kg), thiopental, fentanyl, nitrous oxide, halothane and pancuronium. Residual neuro‐muscular block was antagonized (n = 197) All patients were infused Ringer's lactate solution (4 mL/kg) on arrival at the operating room to all patients. postoperative analgesia with morphine |
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Outcomes | Operative hypotension (MAP < 70% of baseline or 65 mm HG) Length of surgery Length of hospital stay (after the surgery) Mortality at 1 month Acute confusional state in hospital Myocardial infarction Congestive heart failure Pneumonia Thrombosis Pulmonary embolism Cerebrovascular accident |
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Notes | "low dose of heparin as a DVT prophylaxis" | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "randomly assigned into two groups using random‐number table" |
Allocation concealment (selection bias) | Unclear risk | Not mentioned |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not mentioned |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Not mentioned |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | "Three patients of the general anaesthesia group and 10 of the neuraxial block group were excluded because of change in anaesthetic or surgical plan" |
Selective reporting (reporting bias) | Low risk | Recruitment ended with the completion of the protocol in the 387th patient. |
Other bias | High risk | "Groups are similar regarding age, weight and gender ratio." Not in intention‐to‐treat: "Three patients of the GA group and 10 of the NA group were excluded because of change in anaesthetic or surgical plan" |