Law‐Koune 2005.
Methods | Study design: randomized controlled trial (3 arms) Study duration: not reported Study setting: hospital, single centre, France |
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Participants | Adults undergoing elective supratentorial craniotomy for tumour resection (n = 80) Inclusion criteria
Exclusion criteria
Mean age, range (years)
Numbers allocated to each arm
Male gender
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Interventions |
Technique and timing
Dosage 20 mL |
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Outcomes |
Primary
Secondary
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Notes |
Funding No funding source reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | A table of random numbers was used for randomization |
Allocation concealment (selection bias) | High risk | Authors did not provide any details regarding how the allocation sequence was concealed. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: ''the anaesthesiologist, surgeon, and patient were blinded to the solution''. However no details were provided regaining the method used or how or if its adequacy was assessed. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No details were provided as to whether or not those assessing outcomes were blinded to treatments received. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 4 participants were excluded from the final analysis due to postoperative complications: 3 in the control group (2 due to unspecified neurological complications and 1 due to excessive sedation) 1 in the ropivacaine group (due to an unspecified neurological complication) The lack of an intention‐to‐treat analysis made the effect of their exclusion difficult to determine. |
Selective reporting (reporting bias) | Low risk | Outcomes were reported as specified. |
Other bias | Unclear risk | Small study |