Kim 2013b.
Methods | Randomized controlled trial | |
Participants | Age (years, mean ± SD): Group A = 45.3 ± 2.5, Group B = 47.8 ± 2.5, Group C = 43.2 ± 1.9, Group D = 45.3 ± 3.0 Gender (M:F): Group A = 14:16, Group B = 17:12, Group C = 11:19, Group D = 13:15 Inclusion criteria: age 18 years to 65 years, ASA I‐II, elective surgery Exclusion criteria: patients had known hypersensitivity to lidocaine or microemulsion propofol; impaired communication; a renal, hepatic, cardiac, or neurologic problem; or a hypovolaemic state and who refused to provide informed consent Recruitment: 140 patients were enrolled (nine were excluded due to severe pain during ringer lactated solution injection) 131 adult patients were randomly allocated (33, 33, 33 and 32 patients were assigned into group A, B, C and D respectively), 117 patients were analysed Setting: Korea |
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Interventions |
Pretreatment with venous occlusion Patients were randomly divided into four groups Group A (n = 30) received MP (2 mg/kg) after lidocaine pretreatment (0.6mg/kg) with a tourniquet with arm down (venous engorgement) Group B (n = 29) received MP after lidocaine with a tourniquet with arm up (venous gravity drainage) Group C (n = 30) received MP with a tourniquet with arm down Group D (n = 28) (control group) received MP only (with no tourniquet) In groups A and C, the tourniquet was released after MP; in group B, the tourniquet was released before MP. |
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Outcomes | Pain intensity assessed on verbal pain score (VPS) with 11‐point scale by 0 being no pain and 10 being the most excruciating pain Outcomes reported and used
Outcomes sought but not reported
Outcomes reported but not used
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Notes | Period of the study: dates not reported | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Randomization was accomplished by using numbered, sealed envelopes that had a computer‐generated assignment." |
Allocation concealment (selection bias) | Low risk | "Randomization was accomplished by using numbered, sealed envelopes that had a computer‐generated assignment." |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | N/A |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | N/A |
Incomplete outcome data (attrition bias) All outcomes | Low risk | "14 patients were excluded (12 patients due to protocol violation, 2 patients due to lost follow up)." |
Selective reporting (reporting bias) | Unclear risk | N/A |
Other bias | Low risk | The study appears to be free of other sources of bias |