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. 2017 May 11;2017(5):CD001159. doi: 10.1002/14651858.CD001159.pub2

Foss 2007.

Methods RCT
Approved by the ethics committee and written informed consents obtained
Setting: Denmark
Funding: charity
NCT00162630
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
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
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
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
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)