Keld 2000.
Methods | Randomization: yes Participant blinding: yes Provider blinding: no Assessor blinding: yes Dropouts: 1 outcome reported |
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Participants | Country: Denmark ASA: I and II Gender: men and women Mean age: lido: 43; bupi: 46 years Procedures: orthopaedic, general surgery Ambulatory surgery: unclear Surgical positioning: supine Number of participants: 70 |
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Interventions | Drug 1: 5% lido, hyperbaric, fixed dose (2 mL) Drug 2: 0.5% bupi, hyperbaric, fixed dose (2.5 mL) Needle: 25 G, pencil‐point |
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Outcomes | TNS at 1 day Back pain |
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Notes | Follow‐up duration: 1–3 days Follow‐up methods: telephone contact TNS therapy: unclear TNS resolution: 41 hours |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "the patients were randomised to receive…" did not specify the method of randomisation (referring to a random number table, computer‐generated random number sequence, tossing coin, etc.). |
Allocation concealment (selection bias) | Unclear risk | No mention of allocation concealment. |
Participant blinding (performance bias and detection bias) | Low risk | Quote: "the study was performed as a prospective double‐blinded study…" |
Provider blinding (performance bias) | High risk | Quote: "this anaesthesiologist used the local anaesthetic according to the random patient number and was therefore not blinded to the anaesthetic used." |
Assessor blinding (detection bias) | Low risk | Quote: "the patient was contacted… by a different anaesthesiologist, who was blinded to the anaesthetic used…" |
Incomplete outcome data (attrition bias) All outcomes | High risk | Quote: "one patient in the bupivacaine group received general anaesthesia due to insufficient spinal anaesthesia and was excluded from the study." Comment: outcome from dropout not reported. |
Selective reporting (reporting bias) | Unclear risk | Study protocol not available. |