Kang 2011.
Methods | Randomized, placebo‐controlled trial. Participants, personnel, and outcome assessors were blinded. This study evaluated the effectiveness of intravenous lidocaine to reduce postoperative pain in inguinal herniorrhaphy patients. The study was conducted in Korea from December 2009 to September 2010. |
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Participants | Number assessed for eligibility: 87 Number randomized: 64 → 32:32 Number analysed: 32:32 Inclusion criteria Inguinal herniorrhaphy patients aged 18 to 65 years. Exclusion criteria Patients who weighed < 45 kg or > 100 kg, had severe underlying cardiovascular (especially atrioventricular block), renal or hepatic disease and were allergic to local anaesthetics were excluded. Patients were also excluded if they had received opioids or non‐steroidal anti‐inflammatory drugs within the previous one week or were taking these drugs chronically as pain treatment. Baseline details Experimental group (n = 32) Median age (years): 35.5 M = 69%, F = 31% Median weight (kg): 67 ASA I/II/III: 21:/6:/5 Duration of anaesthesia (min): 66.03 Main surgical procedure: unilateral inguinal hernia surgery Control group (n = 32) Median age (years): 34.5 M = 63%, F = 37% Median weight (kg): 66 ASA I/II/III: 25:4:3 Duration of anaesthesia (min): 63.38 Main surgical procedure: unilateral inguinal hernia surgery |
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Interventions |
Experimental group (32 patients) The lidocaine group received an intravenous bolus of 1.5 mg/kg lidocaine 2 min before orotracheal intubation followed by a continuous infusion of 2 mg/kg/hr. The intravenous infusion of lidocaine was started immediately and continued during the operation. Control group (32 patients) Control patients received an intravenous normal saline bolus injection followed by infusion of normal saline. |
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Outcomes | The primary endpoint of the study was the VAS pain score 2 hrs after surgery. Dichotomous
Continuous
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Notes |
Medication "The mode of post‐operative analgesia was continuous infusion of 0.1 µg/kg per hr fentanyl plus, by pushing a button on the PCA system, on‐demand release of a 0.1 µg/kg bolus (total regimen of 100 ml of fentanyl); the PCA had a lockout period of 15 min. In the case of a persistent VAS pain score > 30 mm, an additional rescue analgesia dose of 50 µg fentanyl was injected intravenously by an investigator to lower the VAS pain score to < 30 mm. Post‐operative nausea and vomiting were treated with 4 mg intravenous ondansetron as required." Anaesthesia The anaesthesia regime was standardized in both groups. Funding "This research was supported by Chung‐Ang University Research Grants in 2010." |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "randomization was based on computerized random‐number generation." |
Allocation concealment (selection bias) | Unclear risk | Quote: "the group assignments were kept in a set of sealed envelopes, each bearing only the case number on the outside." |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "all patients, surgeons, anaesthesiologists and the investigator collecting data were unaware of patient´s group assignments." |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "all patients, surgeons, anaesthesiologists and the investigator collecting data were unaware of patient´s group assignments." |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Dropout rate (experimental/control): 9%:13% Quote: "one patient in the control group was excluded from the study at the conclusion of the operation as meperidine was required to treat post‐operative shivering. Another patient who fit the inclusion criteria replaced this patient." We assume that the replacing patient was not randomized based on the description (no response from the authors upon request). Replacement may have an impact on relevant outcomes. |
Selective reporting (reporting bias) | Unclear risk | There is no reference to a trial registry and no published study protocol. |
Other bias | Low risk | The study appears to be free of other sources of bias. |