Voylenko 2013.
| Methods | RCT Setting: Czech Republic Funding: unspecified |
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| Participants | 41 patients undergoing nephron sparing surgery for renal cell carcinoma through transabdominal approach without central ischaemia Exclusion criteria were procedures involving the kidney pelvic system and significant co‐morbidities |
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| Interventions |
Treatment group: intraoperatively: epidural anaesthesia with 0.125% bupivacaine 8 to 9 mL/h, postoperatively: use of epidural analgesics (exact number unclear) Control group: not clearly mentioned (exact number unclear) Unclear whether general anaesthesia was used for all participants Number of participants was entered as 20 in each group for calculation of number of participants included in the review |
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| Outcomes | Pain: "pain levels in the study group were insignificantly lower to control: 2.9 ± 1,1 points versus 3.5 ± 1,6 points (T‐test; P = 0.21)" Length of hospital stay: "Postoperative hospital stay was significantly shorter for study group 4.1 ± 0.8 days versus 6.8 ± 1.1 days (T‐test; P < 0.001)" |
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| Notes | Conference abstract The abstract does not clearly state whether participants in the control group had an epidural. No contact address is provided |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "randomised control trial", no detail |
| Allocation concealment (selection bias) | Unclear risk | Not mentioned |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not mentioned |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not mentioned |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not reported |
| Selective reporting (reporting bias) | Unclear risk | Limited information |
| Other bias | High risk | Groups well balanced: "Patients age was 52.8 ± 10.5 and 51 ± 12.8 respectively in study and control groups. Mean tumour size was 3.4 ± 0.5 cm versus 3.5 ± 0.4 cm; mean glomerular filtration rate 90.1 ± 178 versus 89.7 ± 18.2 mL/min and "ECOG (not defined in the abstract)" status 0.67 ± 0,5 versus 0.72 ± 0.57 for study and control group respectively" Epidural was part of a "fast track" programme that included preoperatively: no bowel preparation, nutrition with high‐carb diet shakes 5 to 7 hours before surgery and cancellation of premedication with narcotic analgesics; intraoperatively: epidural anaesthesia with 0.125% bupivacaine 8 to 9 mL/h, use of non‐steroidal anti‐inflammatory drugs, minimally invasive approach and no drain policy; postoperatively: early (6 hours) start of oral nutrition, early participant mobilization, use of epidural analgesics and no narcotics policy |