Wu 2014.
| Methods | Unblinded, randomized, controlled trial Computer‐generated random sequence, sealed opaque envelopes Follow‐up: 6 months |
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| Participants | Subjects: 79 participants enrolled (60 followed up to 6 months) from one
hospital: Yan Chai Hospital, Hong Kong, China Operation: primary total knee replacement 2 groups (of 30 people each); 19 others excluded for various reasons before or after entering the study Mean age (SD): group 1, 68.9 (± 7.5); group 2, 68.8 (± 6.4) Sex: group 1, 8 males and 22 females; group 2, 8 males and 22 females |
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| Interventions | Spinal anaesthesia (incompletely standardized: 58 participants received
hyperbaric bupivacaine, one received levobupivacaine, and one isobaric
bupivacaine; the volume also varied: 2.5 ± 0.3 mL in one group and 2.6 ± 0.3
mL in the other) Identical standardized multimodal analgesic regimen (if not contraindicated) including paracetamol, sustained release diclofenac, opioids (codeine or morphine), and drugs to prevent the side effects of the NSAIDs and opioids. Unclear how many surgeons performed the procedures.
Participants were not mobilized until POD 1 |
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| Outcomes |
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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 | “These 60 patients were randomized to the CFNB and PCA groups (30 patients in each), using computer‐generated random numbers. Subjects were divided into two groups (odd against even numbers generated by the computer)." |
| Allocation concealment (selection bias) | Low risk | "The case allocation was concealed in sealed envelopes and the mode of analgesia revealed to case anaesthetist and patient after the patient was included in the study.” |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated whether the outcome assessor was blinded to group allocation |
| Incomplete outcome data (attrition bias) All outcomes | High risk | "In all, 79 patients were recruited but 19 were excluded for various reasons . . . [R]eplacements were recruited using the permuted block technique." Some patients were excluded after entering the study for reasons such as failed spinal, infusion stopped, catheter dislodged, manpower limits, etc. |
| Selective reporting (reporting bias) | Low risk | All outcomes were reported, except for the Timed Up and Go test because of missing data |