Etezadi 2013.
Methods | Randomization: yes Participant blinding: unclear Provider blinding: no Assessor blinding: yes Dropouts: 0 |
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Participants | Country: Iran ASA: I and II Gender: men and women Age range: 18–60 years Ambulatory surgery: no Surgical positioning: supine, lithotomy Number of participants: 250 |
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Interventions | Drug 1: 5% lido, hyperbaric, variable dose (1.5–2 mL) Drug 2: 0.5% bupi, isobaric, variable dose (2.5–3 mL) Needle: 25 g sharp and pencil point |
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Outcomes | TNS | |
Notes | Follow‐up duration: 5 days Follow‐up method: in person, unclear after 48 hours ("visited") TNS therapy: NSAIDs TNS resolution: unclear |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "… randomization was achieved by a computer‐generated block of numbers and sealed envelope technique." |
Allocation concealment (selection bias) | Unclear risk | Quote: "… randomization was achieved by a computer‐generated block of numbers and sealed envelope technique." Comment: did not specify allocation by sequentially numbered, sealed, opaque envelopes. |
Participant blinding (performance bias and detection bias) | Low risk | Study was described as "double‐blind" but otherwise participant blinding was not addressed. |
Provider blinding (performance bias) | High risk | Volumes of local anaesthetic were not the same for the 2 interventions, thus provider not blinded. |
Assessor blinding (detection bias) | Low risk | Quote: "the symptoms of TNS… were observed by a neurosurgeon that was blinded to… the type of drug… used for spinal anesthesia." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 250 participants enrolled, data reported for 250 participants. |
Selective reporting (reporting bias) | Unclear risk | Study protocol not available. |