Zaric 2006.
Methods | Randomized trial: computerized random number tables | |
Participants | Single centre in Copenhagen, Denmark 60 participants undergoing TKR with general anaesthesia Inclusion criteria: ASA I to III Exclusion criteria: morphine intolerance, neurological disease, coagulation disturbance and chronic pain and rheumatoid arthritis Mean age (years): 66 ± 7 Female: 53% Number excluded post randomization: 11 participants (four in continuous FNB and seven in epidural group) Number lost to follow‐up: none |
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Interventions | 1. Continuous FNB + sciatic with bolus 30 ml of ropivacaine 7.5 mg/ml and Infusion ropivacaine 2 mg/ml and sufentanil 1 μg/ml at 5 ml/h through femoral nerve catheter; and bolus 30 ml of ropivacaine 7.5 mg/ml and Infusion ropivacaine 0.5 mg/ml at 5 ml/h through sciatic nerve catheter 2. Epidural with ropivacaine 7.5 mg/ml given in 5‐ml aliquots to attain a level of analgesia at Th 10, and infusion ropivacaine 2 mg/ml and sufentanil 1 μg/ml at 5 ml/h All infusions were continued for 55 hours Adjunct analgesics: IV PCA morphine bolus 2 mg with lockout period of six minutes and maximum dose of 20 mg/h, paracetamol 1 g four times daily. If VAS > three at rest, 5 ml ropivacaine 7.5‐mg/ml bolus given through catheters. If pain score > five, 5 ml lidocaine 20‐mg/ml bolus given. After cessation of infusions, rofecoxib 25 mg, sustained‐release morphine (Contalgin) 20 mg (10 mg for participants > 70 years) twice daily and morphine 10 mg |
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Outcomes |
Outcomes of interest for the review: Pain intensity at rest and on movement: visual analogue scale, four hours post operation, 11 am and 14.30 pm on first, second and morning of third postoperative days Total opioid consumption: postoperative days one and two Nausea/vomiting Dizziness (moderate to severe) Sedation Pruritus Urinary retention Adverse events Knee flexion: postoperative day one, discharge Other outcomes: Rehab indices Length of stay |
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Notes | Study author provided additional data on mean (SD) for pain intensity on movement and at rest with knee ROM flexion | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computerized random number tables |
Allocation concealment (selection bias) | Low risk | Sealed opaque envelopes |
Blinding of participants and personnel (performance bias) Subjective outcomes | High risk | Blinding of groups not attempted |
Blinding of outcome assessment (detection bias) Subjective outcomes | High risk | Blinding of groups not attempted |
Incomplete outcome data (attrition bias) All outcomes | High risk | 11 participants (18%) excluded post randomization (four in continuous FNB and six in epidural group because of insufficient analgesia;.one in epidural group had an acute myocardial infarction followed by coronary artery bypass graft) |
Selective reporting (reporting bias) | Low risk | Outcomes predefined |
Other bias | Unclear risk | Potential impact of high attrition on ITT bias may be an issue, as the study did not use ITT analysis |
Abbreviations:
ASA: American Society of Anaesthesiologists; BD: twice a day; BMI: body mass index; COX: cyclo‐oxygenase; CPM: continuous passive motion; CPNB: continuous peripheral nerve block; FNB: femoral nerve block; IQR: interquartile range; ITT: intention‐to‐treat; NSAID: non‐steroidal anti‐inflammatory drug; PACU: postanaesthesia care unit; PCA: patient‐controlled analgesia; PCEA: patient‐controlled epidural analgesia; ROM: range of motion; SD: standard deviation; SF: Short Form; TKR: total knee replacement; VAS: visual analogue scale; WOMAC: Western Ontario and McMaster Osteoarthritis Index.