Zutshi 2005.
| Methods | RCT Approved by the institutional review board and informed consent obtained Setting: United States of America Funding: unspecified |
|
| Participants | Patients undergoing elective segmental intestinal resection by laparotomy. Reoperative cases and patients with co‐morbidities were included | |
| Interventions |
Treatment group: TEA (PCEA) (T8‐T9 or T9‐T10) with bupivacaine and fentanyl for 48 hours (n = 28). Concentrations unspecified Control group: IV PCA (n = 31). Drug unspecified General anaesthesia plus ketorolac and antiemetic prophylaxis for all participants |
|
| Outcomes | Time to first faeces VAS scores (taken as at rest) at 24 and 48 hours Hospital LOS (Before discharge, all participants passed flatus or stool, were comfortable on oral analgesia, could stand and walk independently and had tolerated 3 successive solid meals) Costs |
|
| Notes | Study authors contacted for additional information on 26 July 2014, but did not reply | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Randomization was performed using sealed envelopes" |
| Allocation concealment (selection bias) | Low risk | "Randomization was performed using sealed envelopes" |
| 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 | Data are missing for some outcomes |
| Selective reporting (reporting bias) | Low risk | All results provided |
| Other bias | Unclear risk | Groups well balanced Lack of details on the content of epidural solution and of IV opioids Intention‐to‐treat outcomes retained for this review |
APACHE: Acute Physiology and Chronic Health Evaluation; ARDS: adult respiratory distress syndrome (acute lung injury); ASA: American Society of Anesthesiologists; B: bupivacaine; BP: blood pressure; d:day; EA: epidural anaesthesia or analgesia; EM: epidural morphine; G: gram; Gr: group; IM: intramuscular; IV: intravenous; kg: kilogram; L: litre; LEA: lumbar epidural anaesthesia or analgesia; LOS: length of stay; M: morphine; mcg: microgram; mL: millilitre; MPI: Mannheim Peritonitis Index score; NCT: number of clinical trial; NSAID: non‐steroidal anti‐inflammatory drug; PCA: patient‐controlled analgesia; PCEA: patient‐controlled epidural analgesia; RCT: randomized controlled trial; SD: standard deviation; SIRS: systemic inflammatory response syndrome; T: thoracic; TEA: thoracic epidural anaesthesia or analgesia; VAS: visual or verbal analogue pain score; y: year