Hodgson 2000.
Methods | Randomization: yes Participant blinding: yes Provider blinding: no Assessor blinding: yes Dropouts: 0 |
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Participants | Country: USA ASA: I and II Gender: men and women Mean age: lido: 49 (SD 12); pro: 49 (SD 12) years Procedures: arthroscopy Ambulatory surgery: yes Surgical positioning: supine Number of participants: 70 |
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Interventions | Drug 1: 5% lido, hyperbaric, fixed dose (1 mL) Drug 2: 5% pro, hyperbaric, fixed dose (2 mL) Needle: 24 and 25 G, pencil‐point |
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Outcomes | TNS at 1 day | |
Notes | Follow‐up duration: 3 days Follow‐up method: telephone contact TNS therapy: unclear TNS resolution: 48 hours |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "randomization was accomplished by random selection of blank, closed envelopes assigned by a computer‐generated scheme to lidocaine or procaine by a numerical code which remained unbroken until data collection and assessment of all patients was complete." |
Allocation concealment (selection bias) | Low risk | Quote: "randomization was accomplished by random selection of blank, closed envelopes assigned by a computer‐generated scheme to lidocaine or procaine by a numerical code which remained unbroken until data collection and assessment of all patients was complete." |
Participant blinding (performance bias and detection bias) | Low risk | Quote: "the patient remained blinded to the study drug." |
Provider blinding (performance bias) | High risk | Quote: "…side effects…were managed intraoperatively by the managing anesthesia team, which was not blinded to the spinal drug." |
Assessor blinding (detection bias) | Low risk | Quote: "patients were contacted…by a single anesthesiologist blinded to the agent that the patient had received." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Randomized 70 participants, results reported on 70 participants. |
Selective reporting (reporting bias) | Unclear risk | Study protocol not available. |