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. 2016 Jul 15;2016(7):CD001893. doi: 10.1002/14651858.CD001893.pub2

Senagore 2003.

Methods RCT
Approved by the Institutional Review Board and informed consent obtained
Setting: United States of America
Funding: unspecified
Participants 38 patents scheduled for segmental laparoscopic colectomy
Interventions Treatment group: TEA (T8‐T9 or T9‐T10) with bupivacaine 0.1% and fentanyl 20 mcg/mL for 18 hours (n = 18)
Control group: IV PCA with morphine for 18 hours (n = 20)
General anaesthesia, diclofenac 50 mg orally every 8 hours beginning the evening before surgery and continued after operation, ketorolac 30 mg within 30 minutes of completion of surgery and antiemetic prophylaxis of dexamethasone 8 mg and ondansetron 4 mg for all participants
Outcomes VAS scores at movement at 6 and 24 hours
Hospital length of stay (Criteria for discharge from hospital in both groups of participants included tolerance of 3 consecutive general meals without nausea or vomiting, adequate pain control with oral analgesics and passage of flatus. Length of hospital stay was defined as the number of nights spent in hospital from day of operation until discharge)
Notes Investigators reported no instances of TEA catheter malfunction or complications that required early removal of the catheter
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "computer‐generated random number after giving informed consent"
Allocation concealment (selection bias) Low risk "computer‐generated random number after giving informed consent"
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 "There were no instances of thoracic epidural catheter malfunction or complications that required early removal of the catheter"
 "Forty‐seven patients were randomized during the study but four (two thoracic epidural and two IV opioids) had no resection or a second surgical procedure during their hospital stay, and five (three TEA and two PCA) had protocol violations and were excluded from subsequent analysis"
Selective reporting (reporting bias) Low risk All results reported
Other bias Unclear risk Groups well balanced
Not in intention‐to‐treat: "whose operation was converted to open surgery after randomization were excluded from analysis"