Kim HO 2014.

Methods	Randomized, controlled trial. Single‐blinded. The aim of this study was to evaluate the tolerability of early oral feeding following laparoscopic colorectal cancer surgery and the effects of intravenous lidocaine. The study was conducted at Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea between April 2011 and June 2012. (NCT01346917)
Participants	Number assessed for eligibility: 129 Number randomized: 77→ 38:39 Number analysed: 68→ 32:36 Inclusion criteria Men and non‐pregnant women aged 18 years or older who were scheduled to undergo elective laparoscopic colorectal cancer surgery Exclusion criteria Allergy to local anaesthetic agents or severe cardiovascular, pulmonary, hepatic or renal diseases that could interfere with study outcomes, ASA IV, peritoneal carcinomatosis, open conversion or a stoma created for faecal diversion Baseline details Experimental group (n = 32) Mean age (years): 60.9, SD = 10.6 M = 71.9%, F = 28.1% Mean weight (kg): N/A ASA I/II /III (n): 11:20:1 Mean duration of anaesthesia (min): N/A Mean duration of surgery (min): N/A Main surgical procedures (n): laparoscopic colectomy (32) Control group (n = 36) Mean age (years): 60.1, SD = 11.1 M = 63.9%, F = 36.1% Mean weight (kg): N/A ASA I/II /III (n): 19:15:2 Mean duration of anaesthesia (min): N/A Mean duration of surgery (min): N/A Main surgical procedures (n): laparoscopic colectomy (36)
Interventions	Experimental group (32 patients) A loading dose of 1 mg/kg lidocaine was administered prior to skin incision, and a continuous dose of 1 mg/kg/hr lidocaine with 90 mg ketorolac (NSAID) (in normal saline, total 240 ml) was administered for 24 hrs. Control group (36 patients) Patients randomized to the placebo control group received a loading dose of 5 ml saline and a continuous dose of 90 mg ketorolac in 240 ml saline.
Outcomes	The primary endpoint of the study was the prevalence of postoperative nausea/vomiting and intolerance to early oral feeding caused by nausea/vomiting. Dichotomous Postoperative ileus Episode of nausea/vomiting (time point unclear) Tolerance to early oral feeding Pathologic stage (I, II, III, IV) Comorbidities Previous major abdominal operation Surgical complications (anastomotic leakage, bleeding, chylous ascites, wound discharge, total) Adverse events (mortality) Continuous Pain score at < 24, < 48, < 72, < 96 hrs (VAS 0 to10, data presented graphically) Time to first flatus (hrs, median + IQR) Time to first passage of stool (hrs, median + IQR) Length of hospital stay (postoperative days, median + IQR) Total postoperative opioid consumption (meperidine) (mg, median + IQR) Time to tolerance of regular diet (hrs)
Notes	Small trial sample size (< 200 patients) Power analysis performed (prevalence of postoperative nausea/vomiting, n = 35 per group) Medication All patients received standard mechanical bowel preparation with polyethylene glycol. Glycopyrolate IM injection was used as a preoperative medication for all patients. After surgery, glycopyrrolate and pyridostigmine were administered to reverse the residual neuromuscular blockade. Epidural anaesthesia or other procedures for pain control were not performed in either group. During continuous infusion of 90 mg ketorolac for 24 hrs, relaxation therapy was administered initially for pain management followed by 25 to 50 mg meperidine by slow intravenous injection as needed for pain relief. After removal of the continuous infusion of ketorolac, patients initially received NSAIDs followed by meperidine for pain. Anaesthesia The anaesthesia regime was standardized in both groups. Funding Medical research funds from Kangbuk Samsung Hospital
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: “patients were assigned by computerized blocked randomization (block size was four) after stratification by surgical site (right colectomy versus left colectomy and anterior resection) and method (conventional laparoscopic versus hand‐assisted laparoscopic surgery).”
Allocation concealment (selection bias)	Unclear risk	No statement on allocation concealment.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quote: “this study was single‐blinded with regard to subjects. The study medication was prepared by an anaesthesiologist not involved in further treatment of the patients. Surgeons, patients and the researcher who collected the clinical data in the surgical ward were blinded to study group assignments during the postoperative course. The anaesthesiologist participated in this study was the only person who was not blinded.” “This trial was single‐blinded with regard to subjects because the total dose of lidocaine was heterogeneous among the subjects. Lidocaine was prepared and administered by an anaesthesiologist who participated in this trial. However, this trial was somewhat double‐blind because postoperative management and data collection on the outcome measures were performed by surgeons and the researcher, respectively, who were blinded to study group assignments during the postoperative course.” It is not clear from the description if the attending anesthesiologist who performed anaesthesia was blinded to the group allocation.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: “surgeons, patients and the researcher who collected the clinical data in the surgical ward were blinded to study group assignments during the postoperative course.” “All VAS scoring was performed by the attending nurse who was unaware of the ongoing study.”
Incomplete outcome data (attrition bias) All outcomes	Low risk	Dropout rate (experimental/control): 16%:8% Quote: “nine patients had to be excluded during the perioperative course.” Six patients from the experimental group were excluded (decline to participate (n=2), ileostomy formation (n=3), open conversion (n=1)) and three from the control group (carcinomatosis (n=1) and ileostomy formation (n=2)).
Selective reporting (reporting bias)	Low risk	The study protocol is available (NCT01346917). All of the study’s prespecified primary outcomes that are of interest in the review have been reported in the prespecified way. The protocol was prospectively registered (April 2011).
Other bias	Low risk	The study appears to be free of other sources of bias.