Lynch 1992a.
Methods |
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Participants | 1. 300 patients (ASA I or II) aged 15 to 40 years (196 male, 104 female) undergoing elective orthopaedic procedures were enrolled Exclusion criteria: migraine or chronic severe headache, infection, local anaesthetic allergy or a preference for general anaesthesia Patients randomized to:
2. No patients were excluded from analysis 3. Main characteristics of patients:
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Interventions |
All punctures were done with a 20 G introducer (Braun, Germany) |
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Outcomes | Outcomes were not classified as primary or secondary
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Notes |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Insufficient information to score this item as low or high risk of bias. Quote: "Patients were allocated randomly to have (…)" (page 58) |
Allocation concealment (selection bias) | Unclear risk | Insufficient information to score this item as low or high risk of bias |
Blinding of participants (performance bias) | Unclear risk | Insufficient information to score this item as low or high risk of bias |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Insufficient information to score this item as low or high risk of bias |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No patients were lost to follow‐up |
Selective reporting (reporting bias) | High risk | Adverse events, additional to PDPH, were not reported. Presence of associated symptoms is mentioned in methods, but not reported. |
Other bias | Low risk | No other biases were identified |