De Andres 1999.
Methods |
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Participants | 1. 158 patients enrolled during a 12‐month period (ASA I and II, aged from 20 to 40 years, undergoing lower limb orthopaedic surgery) Exclusion criteria: presence of hypovolaemia, coagulation disorders, infection at the puncture site, use of general anaesthesia, history of headaches, chronic back pain or pregnancy Patients randomized to:
2. No patients were excluded from further analysis 3. Main characteristics of patients:
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Interventions |
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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) | Low risk | Quote: "On arrival at the operating room, the patients were assigned to one of two groups using a randomization table: (…)." (page 548) |
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 | Low risk | Quote: "After surgery, close follow‐up of patients was performed by an investigator blinded to the study protocol". (page 549) |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No patients were lost to follow‐up |
Selective reporting (reporting bias) | Unclear risk | Information about non‐specific headaches is unclear |
Other bias | Low risk | No other biases were identified |