De Jose Maria 2008.
Methods | Randomized controlled trial | |
Participants | N = 80; paediatric; ASA 1‐2; average age 8‐9 yrs; 56 male, 24 female; elective upper limb surgery, Spanish study | |
Interventions |
Injectate in both blocks: ropivacaine 0.5% in a volume up to 0.5ml/kg. Total volume was that needed to achieve adequate local anaesthetic spread around the plexus. This was 6±2 ml in the supraclavicular group Sedation for block and intraoperatively: all patients received a general anaesthetic before the block: 1 MAC sevoflurane in 50% oxygen/air. Fentanyl was given if heart rate or blood pressure increased by 10% or more |
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Outcomes |
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Notes | Surgery started within 15 min of block. This may have
reduced success rates. Two patients in the infraclavicular group had block procedure abandoned after arterial puncture. All outcomes except vascular puncture were analysed on an available‐case basis (N=38). Block performance times reported as mean, range and 95% CI for difference of means. Standard deviation calculated from this data, and also requested from author. Duration of sensory block was only reported for the supraclavicular group. Additional data requested from author. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: “80 children…were prospectively randomized
into two groups…” No further details provided |
Allocation concealment (selection bias) | Unclear risk | Not stated in text |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | No mention of blinding of patients or outcome assessors in text |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Two patients in the infraclavicular group had block procedure abandoned after arterial puncture. All outcomes except vascular puncture were analysed on an available‐case basis (N=38) |
Selective reporting (reporting bias) | Unclear risk | No data reported on duration of sensory and motor block, or on volume of local anaesthetic injected in the infraclavicular group. These are outcomes of lesser importance |
Other bias | High risk | Timing for measurement of outcomes may have been
inappropriate ‐ 15 min is too short a time for
assessment of block efficacy in the reviewers'
opinion The ultrasound‐guided infraclavicular technique was an unusual one – out‐of‐plane – which may have contributed to the incidence of vascular puncture, which in turn led to abandonment and classification of the block as “failed” in these patients |