Wongyingsinn 2011.

Methods	Randomized, controlled trial. No blinding of participants and personnel. Outcome assessors were blinded. This study compared the effect of intraoperative and postoperative IV lidocaine infusion with TEA on postoperative restoration of bowel function in patients undergoing laparoscopic colorectal resection using an Enhanced Recovery Program. The study was conducted in Canada from July 2009 to June 2010 (NCT01155440).
Participants	Number assessed for eligibility: 75 Number randomized: 62 → 31:31 Number analysed: 30:30 Inclusion criteria Patients scheduled for elective laparoscopic colorectal surgery, ASA I to III. Exclusion criteria Allergy to lidocaine, contraindication to have TEA, chronic treatment with opioid, inability to communicate in either French or English or to understand the purpose of the study, severe physical disability, or metastatic carcinoma. Baseline details Experimental group (n = 30) Mean age (years): 58 M = 63.3%, F = 36.7% Mean weight (kg): 80 ASA I/II/III: 9:20:1 Duration of surgery (min): 220 Main surgical procedure (n): right hemicolectomy (9), left hemicolectomy (4), sigmoid resection (4), anterior resection (3), low anterior resection (6), proctocolectomy (4) Control (epidural) group (n = 30) Mean age (years): 61 M = 63.3%, F = 36.7% Mean weight (kg): 74 ASA I/II/III: 12:14:4 Duration of surgery (min): 213 Main surgical procedure (n): right hemicolectomy (10), left hemicolectomy (3), sigmoid resection (2), anterior resection (7), low anterior resection (6), proctocolectomy (2)
Interventions	Experimental group (30 patients) Patients received a bolus of lidocaine 1.5 mg/kg (maximum, 100 mg) just before the induction of anaesthesia, followed by an IV infusion of lidocaine 2 mg/kg per hour for the whole surgical procedure. The infusion was then decreased to 1 mg/kg per hour in the PACU and continued 48 hrs postoperative. Control (epidural) group (30 patients) Control patients received TEA. The neural blockade was maintained during surgery with additional infusion of 5 to 8 ml/hr of bupivacaine 0.25%. A continuous epidural analgesia with bupivacaine 0.1% and morphine 0.02 mg/ml was started in the PACU and continued for 48 hrs on the surgical ward.
Outcomes	The primary endpoint of the study was bowel movement. Dichotomous Postoperative nausea and vomiting within 3 days after surgery Postoperative complications (urinary retention, ileus, bleeding per rectum, exudate from stroma, anastomotic leak) Readmissions Continuous Time to first drink (hr), (data presented as median with IQR) Time to first full diet (hr), (data presented as median with IQR) Time sitting out of bed (min), time walking out of bed (min), (data presented as median with IQR, asymmetric distribution) Readiness to discharge (days), (data presented as median with IQR, asymmetric distribution) Length of hospital stay (days), (data presented as median with IQR, asymmetric distribution) Time to return of bowel function (first flatus, first bowel movement) in 2 subgroups: patients with primary anastomosis (21:22), patients with primary ileostomy (9:8) Postoperative pain score (VRS 0 to 10) at rest, on walking, and on coughing at 24 hrs, 48 hrs, and 72 hrs in 2 subgroups: patients with colon resection (17:15), patients with rectal resection (13:15), (data presented as median with IQR, asymmetric distribution) Intraoperative fentanyl consumption (µg) Morphine consumption (mg), 24 hrs and 48 hrs, either via the epidural route (control group) or the intravenous route (lidocaine group), (data presented as median with IQR) Oral oxycodone consumption (mg) at 72 hrs, (data presented as median with IQR, asymmetric distribution)
Notes	Data for return of bowel function were presented for 2 subgroups (primary anastomosis/primary ileostomy) Data for VRS pain score were presented for 2 subgroups (colon resection/rectal resection) Morphine consumption cannot be compared due to different application routes Small trial sample size (< 200 patients) Power analysis performed (bowel function, n = 25) Medication "As a rescue analgesia, patients in the IL group received PCA using IV morphine for 48 hrs. The PCA was set up at 1 to 2 mg every 7 min with no background infusion and was increased if the VRS at rest exceeded 4 at rest.", "If the VRS (in the TEA group) at rest exceeded 4, the rate of epidural infusion was increased by increments of 1 ml to a maximum of 15 ml/hr. No rescue analgesia with systemic morphine was used.", " If the VRS at rest in both groups exceeds 4 at 48 hours after surgery, TEA or IL infusion would continue, and VRS reassessed every 2 hours.", "In both groups, multimodal analgesia included 500 mg of naproxen twice a day and acetaminophen 1 g 4 times a day for up to 5 days. Both epidural and lidocaine with PCA were discontinued 48 hrs after surgery if VRS at rest was less than 4, and oral oxycodone 5 to 10 mg was then provided every 4 hrs as breakthrough medication." "Prevention of PONV was achieved with droperidol 0.625 mg and dexamethasone 8 mg." Anaesthesia The anaesthesia regime was standardized in both groups. Funding "Funding for the study was provided by the Department of Anesthesia, McGill University Health Centre, Montreal, Quebec, Canada."
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "patients assignments were generated using a published table of random numbers."
Allocation concealment (selection bias)	Unclear risk	Quote: "...sealed in a brown envelope…" Not mentioned sequentially numbered envelopes.
Blinding of participants and personnel (performance bias) All outcomes	High risk	No blinding of participants and personnel possible due to study design.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "all the postoperative data were collected daily by the research assistant unaware of the hypothesis."
Incomplete outcome data (attrition bias) All outcomes	High risk	Dropout rate (experimental/control): 3%:3% Quote: "two patients had to be excluded from final analysis: 1 patient in the TEA group for conversion to laparotomy, and 1 patient in the IL group for unknown drug reaction." The exclusion due to unknown drug reaction may influence the results of the study.
Selective reporting (reporting bias)	Unclear risk	The study protocol is available and all of the study's prespecified primary outcomes that are of interest in the review have been reported in the prespecified way. However, trial registry occurred retrospectively (registered October 2010, study start date June 2009, study completion October 2011). (NCT01155440)
Other bias	Low risk	The study appears to be free of other sources of bias.