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

Hampl 1995a.

Methods Randomization: yes
Participant blinding: yes
Provider blinding: yes
Assessor blinding: yes
Dropouts: 0
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
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
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
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.