Aouad 2001.
Methods | Randomization: yes Participant blinding: yes Provider blinding: no Assessor blinding: yes Dropouts: 0 |
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Participants | Country: Lebanon ASA: I and II Gender: women Mean age: 31 (SD 5) years Caesarean section Surgical positioning: supine Number of participants: 200 |
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Interventions | Drug 1: 5% lido, hyperbaric, fixed dose (1.5 mL) Drug 2: 0.75% bupi, hyperbaric, fixed dose (1.6 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 method: telephone contact |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "patients were allocated randomly by sealed envelope…" Comment: did not specify the method of randomization (referring to a random number table, computer‐generated random number sequence, tossing coin, etc.). |
Allocation concealment (selection bias) | Unclear risk | Quote: "patients were allocated randomly by sealed envelope…" Comment: did not specify allocation by sequentially numbered, sealed, opaque envelopes. |
Participant blinding (performance bias and detection bias) | Low risk | Quote: "patients were blinded as to the spinal anesthetic used." |
Provider blinding (performance bias) | High risk | Quote: "the anesthesiologist who administered the spinal anesthetic and collected the data on sensory and motor blockade was not blinded as to the study groups." |
Assessor blinding (detection bias) | Low risk | Quote: "all patients were interviewed… by an anesthesiologist who was unaware of the local anesthetic given." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 200 participants enrolled. Results reported for 200 participants. |
Selective reporting (reporting bias) | Unclear risk | Study protocol not available. |