Diakomi 2014.
| Methods | RCT Approved by the ethics committee and informed consents obtained Setting: Greece Funding: unspecified NCT02037633 |
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| Participants | 41 ASA I‐III participants, aged 38 to 94 years, scheduled for hip fracture repair Excluded: contraindications for central nervous blockade, impaired cognition or dementia, multiple fractures, any previous analgesic administration in last 12 hours before surgery |
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| Interventions |
Treatment group: fascia iliaca block, modified Dalen's technique with 40 mL ropivacaine 0.5% injected while caudal pressure maintained, then turned lateral (fracture side up) for spinal 20 minutes later (n = 21) Control group: IV fentanyl 1.5 mcg/kg, then turned lateral (fracture side up) for spinal 5 minutes later (n = 20) Spinal anaesthesia for surgery. IV PCA with morphine after surgery |
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| Outcomes | Pain at rest and on movement at 20 minutes after the block (or 5 minutes after fentanyl administration; movement = positioning for spinal anaesthesia) Opioid requirement during first 24 hours after surgery |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Patients were randomly assigned, using a sealed envelope method" |
| Allocation concealment (selection bias) | Low risk | "Patients were randomly assigned, using a sealed envelope method" |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Pain scores were assessed by a blind observer who entered the operating room only after the analgesic intervention (IV fentanyl administration or fascia iliaca block performance) had taken place. Landmarks were drawn on all participants, and gauze was applied to the “puncture” site for all participants. Each participant was aware of his/her group allocation because we considered a placebo injection in the inguinal area not acceptable. The observer who recorded participant satisfaction was unaware of group allocation and was not involved in any other step of the study |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Pain scores were assessed by a blind observer who entered the operating room only after the analgesic intervention (IV fentanyl administration or fascia iliaca block performance) had taken place. Landmarks were drawn on all participants, and gauze was applied to the “puncture” site for all participants. Each participant was aware of his/her group allocation because we considered a placebo injection in the inguinal area not acceptable. The observer who recorded participant satisfaction was unaware of group allocation and was not involved in any other step of the study |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | None lost to follow‐up. One participant withdrew consent |
| Selective reporting (reporting bias) | Low risk | All measurements mentioned in methods section given in results section |
| Other bias | Low risk | Groups well balanced |