Hampl 1995a.
Methods | Randomization: yes Participant blinding: yes Provider blinding: yes Assessor blinding: yes Dropouts: 0 |
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Participants | Country: Switzerland ASA: I and II Gender: women Age range: 19–81 years Procedures: gynaecological Ambulatory surgery: no Surgical positioning: lithotomy Number of participants: 44 |
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Interventions | Drug 1: 5% lido, hyperbaric, fixed dose (1.5 mL) Drug 2: 0.5% bupi, hyperbaric, fixed dose (1.5 mL) Needle: 25 G, pencil‐point |
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Outcomes | TNS at 1 day Back pain | |
Notes | Follow‐up duration: 1–4 days Follow‐up method: direct contact TNS therapy: unclear TNS resolution: all recovered |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "patients were randomly assigned to receive one of the following three local anesthetic solutions…" 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 | No mention of the method of allocation concealment (central allocation, sequentially numbered, sealed, opaque envelopes, or sequentially numbered drug containers of identical appearance). |
Participant blinding (performance bias and detection bias) | Low risk | Quote: "…the aim of this prospective double‐blinded study was…" |
Provider blinding (performance bias) | Low risk | Quote: "the drugs were delivered by the pharmacy in blinded vials each containing 2 ml local anesthetic solution." |
Assessor blinding (detection bias) | Low risk | Quote: "on post‐operative day 1, all patients were evaluated for TRI by oral interrogation by one anesthesiologist who was unaware of details of the anesthesia procedure." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote "… we studied 44 ASA class I and II patients…" Comment: results reported for 44 participants. |
Selective reporting (reporting bias) | Unclear risk | Study protocol not available. |