Domac 2015.
Methods | RCT Approved by the ethics committee and informed consents obtained Setting: Turkey Funding: departmental |
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Participants | 40 ASA I‐III participants aged 65 to 80 years undergoing femoral fracture repair under spinal anaesthesia Excluded: patients < 65 years of age or > 80 years of age, with peripheral neurological disease, mental disorders, allergy to amide local anaesthetics, coagulation/haemostasis diseases, moderate or severe liver or kidney failure, contraindication to or refusing fascia iliaca block |
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Interventions |
Treatment group: fascia iliaca block with 15 mL of 0.5% bupivacaine and 15 mL of 2% lidocaine (n = 20) Control group: no block (n = 20) Spinal anaesthesia for surgery and IV patient‐controlled analgesia with morphine for postoperative analgesia for all participants |
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Outcomes | Pain at rest and on movement (positioning for spinal) and after surgery Opioids requirements for the first 4 and 48 hours Participant satisfaction |
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Notes | SD of 0.00 entered as 0.001 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "divided into two equal groups for this prospective double‐blind study", no details |
Allocation concealment (selection bias) | Unclear risk | Not mentioned |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants in control group received no block |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Study is said to be double‐blinded. No sham block reported. Unclear who was the outcome assessor for pain scores |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No drop‐out |
Selective reporting (reporting bias) | Low risk | All measurements mentioned in methods section given in results section |
Other bias | Low risk | Groups well balanced |