Foss 2007.
Methods | RCT Approved by the ethics committee and written informed consents obtained Setting: Denmark Funding: charity NCT00162630 |
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Participants | Orthopaedic hospital in Copenhagen, Denmark
48 participants with a hip fracture
Mean age: 80 years (range 69‐88)
Percentage female: 73%
Lost to follow‐up: none Excluded: refusal to participate in the study, previous surgery in the affected hip, regular prefracture opioid or glucocorticoid therapy, alcohol or substance abuse, infection at the injection site, morphine intolerance, any previous opioid administration for acute pain and non‐confirmation of hip fracture suspicion on x‐ray |
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Interventions |
Treatment group: fascia iliaca compartment blockade with 40 mL 1% mepivacaine and epinephrine based on landmarks to fractured limb with saline injection into the contralateral gluteal region (n = 24) Control group: saline injection into fractured side at the site of the fascia iliac block and injection of morphine (0.1 mg/kg) into the contralateral gluteal region (n = 24) After 3 hours, all participants received epidural analgesia |
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Outcomes | Pain scores at rest and on movement (15‐degree leg raise) 30 minutes after block Use of supplementary opiates during first 3 hours after block placement |
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Notes | Length of follow‐up: till 3 hours after the block No side effects attributable to the fascia iliac block were noted in any participants during their hospital stay Before block placement, pain at rest was significantly less (P = 0.05) in participants with intracapsular fractures (median 2, (interquartile range (IQR) 0–5)) vs those who had trochanteric (median 4, (IQR 2–5)) or subtrochanteric fractures (median 5, IQR 4–7), but no significant difference in movement‐associated pain between fracture types, which was median 8 (IQR 6.5–10), 9 (IQR 8–10) and 10 (IQR 8–10) for intracapsular, trochanteric and subtrochanteric fractures, respectively |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomized trial: method stated as via a computer‐generated list using treatments prepared by a nurse not involved in collection of participant data |
Allocation concealment (selection bias) | Low risk | "the medicine used for each individual patient was prepared by a nurse not otherwise involved with the collection of patient data" |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Study was double‐blind |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Study was double‐blind |
Incomplete outcome data (attrition bias) All outcomes | Low risk | One participant did not have a fracture but only a severe contusion and was excluded after x‐ray; an extra participant was therefore included on a new number Two participants (1 from each group) had protocol violations because they received sufentanil as supplementation instead of morphine; both of these supplementations occurred in the post‐anaesthesia care unit more than 60 minutes after block placement |
Selective reporting (reporting bias) | Low risk | All measurements mentioned in methods section given in results section |
Other bias | High risk | Groups well balanced except for higher proportion of male participants in the block group. Participants in the block group had higher pain scores on admission (P = 0.04) |