Kadic 2009.
Methods | Partially blinded, randomized, controlled trial Random allocation to a group by drawing a sealed envelope from a pile Follow‐up: 3 months |
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Participants | Subjects: 58 participants enrolled (53 analysed, 48 followed up to 3
months) from one university hospital: Radboud University Nijmegen Medical
Centre in the Netherlands Operation: primary total knee replacement 2 groups (of 27 and 26 people) Mean age (SD): group 1, 67.4 (± 12); group 2, 66.8 (± 11) Sex: group 1, 7 males and 20 females; group 2, 7 males and 19 females |
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Interventions | Standardized anaesthetic: spinal using 15 mg of 5 mg/mL isobaric
bupivacaine
Standard analgesic regimen using paracetamol, diclofenac and a morphine IV PCA (bolus 1 mg, lockout 6 minutes) |
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Outcomes |
Catheter position was tested immediately after insertion using lidocaine; however, there is no information as to whether any of the blocks needed additional troubleshooting. |
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Funding source | Not provided | |
Declarations of interest | None reported | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "For the randomization procedure, 58 sealed envelopes enclosed a note of either the study or the control group. A blinded operating room nurse drew an envelope, which allocated the patient to one of the groups." |
Allocation concealment (selection bias) | Low risk | As above: random draw procedure with sealed envelopes |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No mention of blinding for participants or personnel assessing participants during their hospital stay |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "The knee function was assessed by a blinded, independent physician, 3 months after surgery at the orthopaedic outpatient centre." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | "[F]ive patients were excluded from the analysis due to protocol violations
(one study, two control), a severe adverse reaction to morphine (one
control) and for not meeting the inclusion criteria (one study)." At the 3‐month assessment, data from only 48 patients are given (21 in the study group, and 17 in the control group), but no explanation is given as to why 5 more patients were lost to follow‐up. |
Selective reporting (reporting bias) | Low risk | Knee Score and WOMAC components reported as mean and SD |