Lee 2011.
| Methods | Randomized trial: method not stated | |
| Participants | Single centre from Seoul, Korea 80 participants undergoing unilateral TKR Exclusion criteria: study drug allergy, opioid dependence, history of previous postoperative nausea, vomiting (PONV) and motion sickness, contraindication for epidural block (previous back surgery, bleeding diathesis and neurological dysfunction), contraindication to FNB (infection at injection site), inability to use the patient‐controlled epidural analgesia device and to comprehend the VAS for pain assessment Mean age (years): 68 (single‐shot FNB group) versus 70 (epidural group) Female: 91% Number excluded post randomization: two participants from FNB group excluded from analysis because of catheter dislodgement Number lost to follow‐up: none |
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| Interventions | 1. Single‐shot FNB with 0.25% levobupivacaine (30 ml) with 5 μg/ml epinephrine; patient‐controlled epidural analgesia (PCEA) via epidural catheter for 48 hours 2. PCEA via epidural catheter; infusion comprised 0.2% ropivacaine plus fentanyl 3 μg/ml, and programmed to deliver at basal rate of 4 ml/h, 3‐ml bolus dose, with lockout duration of 10 minutes, for 48 hours Adjunct analgesics: meperidine (50 mg) IV if participants reported pain ≥ 50 mm on VAS at rest |
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| Outcomes |
Outcomes of interest for the review: Pain intensity at rest and on movement: visual analogue scale at zero to six hours, six to 24 hours, 24 to 48 hours Proportion of participants in pain: from zero to 48 hours Nausea/vomiting Participant satisfaction: 48 hours Neurological injury Other outcomes: Total patient‐controlled epidural analgesia consumption at 24 hours and 48 hours Supplementary meperidine |
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| Notes | Additional information regarding study methods sought, but study authors could not be reached | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Method not stated |
| Allocation concealment (selection bias) | Low risk | Sealed envelopes |
| Blinding of participants and personnel (performance bias) Subjective outcomes | High risk | Quotes: "Patients and treating clinicians were not blinded as to study group randomization"; "Anesthesiologist who visited patients during the postoperative period was not aware of patients’ assignments" |
| Blinding of outcome assessment (detection bias) Subjective outcomes | Unclear risk | Not stated |
| 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 |