Yun 2009.
Methods | RCT Approved by the ethics committee and written informed consents obtained Setting: Korea Funding: unspecified |
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Participants | 40 ASA physical status I–III participants aged 62–88 years with isolated femoral neck fracture Excluded: known allergy to amide local anaesthetics, haemorrhagic diathesis, peripheral neuropathy, mental disorders |
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Interventions |
Treatment group: fascia iliaca with 30 mL 0.375% ropivacaine (n = 20) Control group: IV alfentanil 10 mcg/kg followed by 0.25 mcg/kg/min starting 2 minutes before spinal (n = 20) Participants were moved to the operating suite for the spinal 20 minutes after block placement. Spinals were performed in lateral decubitus position on the side best tolerated by the participant. When a participant reported a VAS 4 during this positioning, the procedure was stopped, and 100 mg of IV alfentanil was administered in both groups |
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Outcomes | Pain scores on movement at 30 minutes after block placement (positioning for spinal anaesthesia) and at rest at 6 and 24 hours after surgery Participant satisfaction (yes/no: 1 = good (if necessary, I would repeat the procedure) and 2 = bad (I would never repeat the procedure again)) Opioids at 24 hours No adverse systemic toxicity of ropivacaine was noted, and neither vascular puncture nor paraesthesia was elicited in the fascia iliaca block group. No complications, such as haematoma or persistent paraesthesia, were observed in participants with a fascia iliaca block within 24 hours after the operation |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Randomly assigned, using an allocation sequence (which was generated by Y. H. Kim using a computer)" |
Allocation concealment (selection bias) | Low risk | "The random allocation sequence was concealed until group was assigned (by J. W. Hwang)" |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not mentioned |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not mentioned |
Incomplete outcome data (attrition bias) All outcomes | Low risk | None lost to follow‐up No failed block mentioned. 40% (8 of 20) of participants had a complete block (3 nerves) and 60% (12 of 20) had blockade of 2 nerves (lateral femoral cutaneous and femoral) |
Selective reporting (reporting bias) | Low risk | All results mentioned in methods section given in results section |
Other bias | Low risk | Groups well balanced |
ASA: American Society of Anesthesiologists physical status
DSM: Diagnostic and Statistical Manual of Mental Disorders
ECG or EKG: electrocardiogram
ED: emergency department
FNB: femoral nerve block
G: gram
h: hour
IM: intramuscular
IV: intravenous
IQR: interquartile range
mcg: microgram
mg: milligram
mL: millilitre
n: number
PCA: patient‐controlled analgesia
RCT: randomized controlled trial
SC: subcutaneous
VAS or VRS: = visual or verbal analogue/response scale