Wang 2002.
| Methods | Randomized trial: drawing marked cards from a deck | |
| Participants | Single centre in Henry Ford Hospital, Detroit, USA 30 participants undergoing TKR Inclusion criteria: age 40 to 70 years Exclusion criteria: hypersensitivity to the test substance or co‐morbid condition that might compromise safety or ability to comply with study procedures Mean age (years): single‐shot FNB: 67 ± 8; IV PCA: 66 ± 10 Female: 63% Number excluded post randomization: none Number lost to follow‐up: none |
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| Interventions | 1. Single‐shot FNB with 0.25% bupivacaine with epinephrine 1:100,000. Nerve identified via nerve stimulator. IV PCA morphine 1‐mg doses with five‐minute lockout 2. IV PCA morphine 1‐mg doses with five‐minute lockout; placebo FNB with 40 ml N/saline Co‐analgesics: not stated |
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| Outcomes |
Outcomes of interest for the review: Pain intensity at rest and on movement: visual analogue scale, PACU, postoperative days one to three Total opioid consumption: postoperative days one and two Morphine related adverse effects Knee flexion postoperative day one, discharge Other outcomes: Distance of ambulation Distance goal met Length of stay |
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| Notes | Study author contacted for additional data on morphine consumption but could not provide the information | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Drawing marked cards from mixed pack with equal numbers of each designation |
| Allocation concealment (selection bias) | Low risk | Blindly drawn marked cards from mixed pack with equal numbers of each designation |
| Blinding of participants and personnel (performance bias) Subjective outcomes | Low risk | Quote: "placebo‐controlled, double‐blind study" |
| Blinding of outcome assessment (detection bias) Subjective outcomes | Low risk | All study personnel including outcome assessors blinded to treatment group assignment . |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropouts/withdrawals |
| Selective reporting (reporting bias) | Low risk | Outcomes predefined |
| Other bias | Low risk | Appears to be free of other sources of bias |