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. 2019 Dec 1;2019(12):CD003006. doi: 10.1002/14651858.CD003006.pub4

Keld 2000.

Methods Randomization: yes
Participant blinding: yes
Provider blinding: no
Assessor blinding: yes
Dropouts: 1 outcome reported
Participants Country: Denmark
ASA: I and II
Gender: men and women
Mean age: lido: 43; bupi: 46 years
Procedures: orthopaedic, general surgery
Ambulatory surgery: unclear
Surgical positioning: supine
Number of participants: 70
Interventions Drug 1: 5% lido, hyperbaric, fixed dose (2 mL)
Drug 2: 0.5% bupi, hyperbaric, fixed dose (2.5 mL)
Needle: 25 G, pencil‐point
Outcomes TNS at 1 day
Back pain
Notes Follow‐up duration: 1–3 days
Follow‐up methods: telephone contact
TNS therapy: unclear
TNS resolution: 41 hours
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "the patients were randomised to receive…" did not specify the method of randomisation (referring to a random number table, computer‐generated random number sequence, tossing coin, etc.).
Allocation concealment (selection bias) Unclear risk No mention of allocation concealment.
Participant blinding (performance bias and detection bias) Low risk Quote: "the study was performed as a prospective double‐blinded study…"
Provider blinding (performance bias) High risk Quote: "this anaesthesiologist used the local anaesthetic according to the random patient number and was therefore not blinded to the anaesthetic used."
Assessor blinding (detection bias) Low risk Quote: "the patient was contacted… by a different anaesthesiologist, who was blinded to the anaesthetic used…"
Incomplete outcome data (attrition bias) 
 All outcomes High risk Quote: "one patient in the bupivacaine group received general anaesthesia due to insufficient spinal anaesthesia and was excluded from the study."
Comment: outcome from dropout not reported.
Selective reporting (reporting bias) Unclear risk Study protocol not available.