Fanelli 2009.
| Methods | Randomization: yes Allocation concealment: yes Participant blinding: unclear Provider blinding: no Assessor blinding: unclear Dropouts: 0 |
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| Participants | Country: Italy ASA: I and II Gender: unclear Age range: 18–80 years Ambulatory surgery: yes Surgical positioning: supine Number of participants: 30 |
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| Interventions | Drug 1: 1% lido, isobaric, fixed dose (5 mL) Drug 2: 0.5% ropi, isobaric, fixed dose (2 mL) Needle: 25 g, pencil‐point |
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| Outcomes | TNS at 1 and 7 days | |
| Notes | Follow‐up: 7 days Follow‐up method: telephone contact TNS therapy: ketoprofen, tramadol TNS resolution: by 7 days |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "using a computer‐generated sequence of numbers for randomisation, and sealed envelopes for allocation concealment, patients were allocated to receive a spinal injection of either 50 mg of plain lidocaine 10 mg/ml or 10 mg of plain ropivacaine 5 mg/ml." |
| Allocation concealment (selection bias) | Unclear risk | Quote: "using a computer‐generated sequence of numbers for randomisation, and sealed envelopes for allocation concealment…" Comment: did not specify allocation by sequentially numbered, sealed, opaque envelopes. |
| Participant blinding (performance bias and detection bias) | Unclear risk | Quote: "we therefore conducted a prospective, randomised, blind study…" Comment: no description of participant blinding provided. |
| Provider blinding (performance bias) | High risk | Quote: "the anaesthesiologist performing the spinal block, who was aware of patient's group allocation, was not involved in patient's follow‐up." |
| Assessor blinding (detection bias) | Unclear risk | Quote: "after spinal injection, a blinded observer recorded progression and recovery from the spinal block, until home discharge criteria were achieved." Comment: no statement regarding the blinding status of the person performing the telephone interview assessing TNS symptoms. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropouts. |
| Selective reporting (reporting bias) | Unclear risk | No study protocol available. |