Swenson 2010.
Methods | Randomized, controlled trial. No blinding of participants, personnel, and outcome assessors. This study compared postoperative epidural analgesia and IV infusion of local anaesthetic on ileus duration and hospital stay in patients after colon surgery. The study was conducted in the USA from April 2005 to July 2006 (NCT00600158). |
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Participants | Number assessed for eligibility: N/A Number randomized: 45 → 24:21 Number analysed: 22:20 Inclusion criteria Patients aged 18 to 75 years of ASA I to III, scheduled for elective colon resection. Exclusion criteria Allergy to local anaesthetics, myocardial infarction within 6 months before surgery, liver disease (aspartate aminotransferase, alanine aminotransferase, or bilirubin 92.5 times the upper limit of normal), renal impairment (creatinine clearance 60 ml/min), systemic corticosteroid use, chronic use of opiates, unwillingness or contraindication to epidural analgesia, pregnancy, or active breast‐feeding. Baseline details Experimental group (n = 22) Median age (years): 52 M = 45%, F = 55% Median BMI (kg/m2): 25 ASA I/II/III: 1:14:7 Duration of surgery (min): 181 Main surgical procedure (n): subtotal colectomy (2), total abdominal colectomy (0), low‐anterior resection/abdominal perineal resection/ileal pouch‐anal anastomosis (20), lyses of adhesion, small‐bowel resection with primary anastomosis and ileostomy (0), closure of end ileostomy with bowel resection (0) Control (epidural) group (n = 20) Median age (years): 49 M = 80%, F = 20% Median BMI (kg/m2): 28 ASA I/II/III: 1:18:0 Duration of surgery (min): 175 Main surgical procedure (n): subtotal colectomy (4), total abdominal colectomy (1), low‐anterior resection/abdominal perineal resection/ileal pouch‐anal anastomosis (12), lyses of adhesion, small‐bowel resection with primary anastomosis and ileostomy (1), closure of end ileostomy with bowel resection (1) |
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Interventions |
Experimental group (22 patients) Before induction of general anaesthesia, patients received IV lidocaine (11 patients: 2 mg/min in patients < 70 kg, 3 mg/min in patients > 70 kg, and 11 patients: 1 mg/min in patients < 70 kg, 2 mg/min in patients > 70 kg). The day after return of bowel function, the lidocaine infusion was turned off. If flatus had not occurred on the fifth POD, IV lidocaine was discontinued. Control group (20 patients) Patients received an epidural analgesia (bupivacaine 0.125% and hydromorphone 6 Kg/ml were started at 10 ml/hr within 1 hr of the end of surgery). |
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Outcomes | The primary endpoint of the study was time to first bowel movement. Dichotomous
Continuous
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Notes |
Medication "When fentanyl was used rather than morphine, it was converted to morphine equivalents using a conversion ratio of 100 µg fentanyl = 10 mg morphine." "In the recovery area, pain was assessed using an 11‐point verbal scale (0 to 10) every 15 min, and scores greater than 3 were treated with either fentanyl 50 µg every 10 min or morphine 4 mg every 20 min as needed. After transfer to the ward, all patients received PCA for breakthrough pain. Initial PCA setting included morphine 2 mg IV demand dose with 6‐min lockout interval (10 mg/hr maximum). Fentanyl was used in an appropriate dose if the patient reported an allergy to morphine." Anaesthesia The anaesthesia regime was standardized. Funding No funding mentioned |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "patient assignments were generated using a published table of random numbers." |
Allocation concealment (selection bias) | Unclear risk | Quote: "...stored in sealed envelopes before initiation of the study protocol." Not mentioned sequentially numbered and opaque envelopes. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding possible due to study design. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No blinding possible due to study design. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Dropout rate (experimental/control): 8%:5% Withdrawals were described. Quote: "if therapy outside the standard protocol was required, the patient was withdrawn from the study and followed in an intent‐to‐treat manner for assessment of primary outcomes." |
Selective reporting (reporting bias) | Unclear risk | The study protocol is available and all of the study's prespecified primary and secondary outcomes that are of interest in the review have been reported in the prespecified way. However, trial registry occurred retrospectively (registered January 2008, study completed July 2006). (NCT00600158) |
Other bias | High risk | Fifty percent of the patients in the lidocaine group received higher doses of lidocaine infusion than the other 50%. The authors used two different local anaesthetics: bupivacaine for epidural administration and lidocaine for IV administration. The starting time of local anaesthetics infusion was different between the groups (lidocaine: before induction of general anaesthesia, Epidural: within 1 hr of the end of surgery). There were differences in the proportion of female patients (20% in the epidural group and 55% in the IV lidocaine group; P value = 0.021) and distribution of ASA scores (P value = 0.014: the IV lidocaine arm included all the ASA III patients). |