Zhu 2013.
Methods | RCT Approved by the ethics committees and written informed consent obtained for all patients Setting: China Funding: unspecified |
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Participants | 67 patients undergoing D2 (systematic dissection of lymph nodes in the second tier with clear histological margins.) radical gastrectomy for gastric cancer | |
Interventions |
Treatment group: TEA (T8‐T9) PCEA with bupivacaine 0.05% and morphine 0.1 mg/mL for 48 hours (n = 34) Control group: IV PCA with morphine (n = 33) General anaesthesia for all participants; pethidine was used as a supplemental drug for breakthrough pain in both groups |
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Outcomes | Time to first flatus (hours) VAS at rest at 24 and 48 hours VAS on movement (coughing) at 24 and 48 hours Anastomotic leak Hospital LOS (Predetermined discharge criteria were used to measure length of hospital stay after the operation. Criteria were defined as eating a normal diet, tolerating clear fluids for 24 hours, having no complaints of pain, providing no evidence of complications for 24 hours and obtaining consent from the participant) |
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Notes | Study authors contacted for additional information on 13 July 2014, but did not reply | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "randomly assigned", no details |
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 | Low risk | 7 participants excluded from analysis |
Selective reporting (reporting bias) | Low risk | All results provided |
Other bias | Unclear risk | Groups well balanced Not in intention‐to‐treat |