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

Lugli 2010.

Methods RCT
Approved by the ethics committee and written informed consent obtained
Setting: Canada
Funding: governmental
Participants 24 patients undergoing elective colorectal surgery
Exclusion criteria were severe cardiac, hepatic, renal or metabolic disorders; diabetes mellitus type 1 with plasma albumin
 concentration < 35 g/L; more than 10% weight loss during the preceding 3 months; anaemia (haematocrit level < 30%); use of steroids; previous spine surgery limiting use of an epidural catheter; and pregnancy
Interventions Treatment group: thoracic (T8‐T10) epidural analgesia with 0.5% bupivacaine for a sensory level from T4 to S1, maintained with an infusion of 0.25% bupivacaine during surgery and 0.1% bupivacaine plus fentanyl 3 mcg/mL for 48 hours after surgery (n = 12)
Control group: IV patient‐controlled analgesia with morphine (n = 12)
Outcomes Pain: Pain scores at rest, at 12 and 24 hours after surgery and during the study on the second postoperative day never exceeded the value of 4, and no participant in either group reported severe pain
Notes Data not extractable enough. Study authors contacted; replied on 4 May 2015, that they would send the data but never did so
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "randomly allocated by a computer‐generated schedule" and "stratified for presence/absence of diabetes type 2"
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 No loss to follow‐up
Selective reporting (reporting bias) Low risk All results reported
Other bias Low risk Groups well balanced