Lauwick 2009.
Methods | Randomized, placebo‐controlled trial. No statement on blinding of participants and outcome assessors. The anaesthesiologists were blinded. This study was performed to assess the effect of intra‐ and postoperative lidocaine infusion on postoperative functional walking capacity, as a measure of surgical recovery in patients undergoing laparoscopic prostatectomy. The study was conducted in Canada from May 2007 to February 2008. |
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Participants | Number assessed for eligibility: N/A Number randomized: 40 → 20:20 Number analysed: 20:20 Inclusion criteria Male patients undergoing laparoscopic prostatectomy. Exclusion criteria ASA physical status ≥ 4, history of hepatic, renal, or cardiac failure, organ transplant, insulin‐dependent diabetes mellitus, morbid obesity (BMI > 40 kg m²), chronic use of opioids, allergy to local anaesthetics, or inability to comprehend pain assessments. Baseline details Experimental group (n = 20) Mean age (years): 60 M = 100%, F = 0% Mean weight (kg): 79 ASA I/II/III: 5:14:1 Duration of surgery (min): 262.5 Main surgical procedure: laparoscopic prostatectomy Control group (n = 20) Mean age (years): 59 M = 100%, F = 0% Mean weight (kg): 82 ASA I/II/III: 10:7:3 Duration of surgery (min): 240 Main surgical procedure: laparoscopic prostatectomy |
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Interventions |
Experimental group (20 patients) At induction of anaesthesia, the lidocaine group received an i.v. bolus injection of lidocaine 1.5 mg/kg up to a maximum of 100 mg, followed by a continuous infusion of lidocaine 2 mg/kg/hr until the end of surgery. Control group (20 patients) Patients in the control group received an equivalent volume of saline 0.9%. |
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Outcomes | The primary endpoint of the study was functional walking capacity. Dichotomous
Continuous
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Notes |
Medication "PCA morphine (1 mg bolus, 7 min lockout) was started in PACU and continued for 48 hrs. Patients also received acetaminophen 1.0 g 6 hourly and naproxen 500 mg 12 hourly for the first 72 hrs. Once PCA morphine was discontinued, patients were offered oxycodone 5–10 mg 4 hourly if the VAS (0 = no pain and 10 = excruciating pain) was > 3 at rest. Ondansetron 2 mg i.v. was prescribed for persistent nausea (lasting > 5 min) or vomiting." Anaesthesia The anaesthesia regime was standardized in both groups. Funding "Dr S. Lauwick is a recipient of a clinical fellowship in anaesthesia for minimally invasive surgery from the Steinberg‐Bernstein Centre for Minimally Invasive Surgery and the Montreal General Hospital Foundation, and a clinical research grant from the CHU of LIEGE, Belgium. This work was supported by internal funds, Department of Anesthesia, McGill University Health Centre." |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "…patients were randomly assigned (using a computer‐generated randomization schedule…" |
Allocation concealment (selection bias) | Unclear risk | Quote: "….sealed brown envelopes…" Not mentioned that envelopes were sequentially numbered. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "the anaesthesiologists (S.L. and F.C.) who executed the study protocol were blinded to the group allocation and were not involved in preoperative or postoperative data collection." No statement on blinding of participants and other personnel. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No statement on blinding of outcome assessors. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No withdrawals. No exclusions. |
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. |