Setting The setting was hospital. The economic analysis was conducted in Toronto, Montreal and Laval, Canada.

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1 Electromotive drug administration of lidocaine as an alternative anesthesia for transurethral surgery Jewett M A, Valiquette L, Sampson H A, Katz J, Fradet Y, Redelmeier D A Record Status This is a critical abstract of an economic evaluation that meets the criteria for inclusion on NHS EED. Each abstract contains a brief summary of the methods, the results and conclusions followed by a detailed critical assessment on the reliability of the study and the conclusions drawn. Health technology The use of intravesical lidocaine using electromotive administration, general or spinal anaesthesia, or no anaesthesia for patients undergoing bladder procedures, including biopsy, transurethral resection, and hydrodistention. Type of intervention Pain management; Treatment. Economic study type Cost-effectiveness analysis. Study population The study included adult patients requiring either cold cup bladder biopsy plus hydrodistention where indicated, or transurethral resection. Patients with benign prostatic hyperplasia or prostatic carcinoma were eligible for the study. The exclusion criteria included: enlarged median prostate lobe, active haematuria, inflammatory or urinary tract infections, pregnancy, psychological instability, or known allergies to study medications. Setting The setting was hospital. The economic analysis was conducted in Toronto, Montreal and Laval, Canada. Dates to which data relate Dates for collection of effectiveness or resource data were not stated. The price year was Source of effectiveness data Effectiveness data were derived from a single study. Link between effectiveness and cost data Resource data were collected using the same patient sample as that used in the clinical analysis. Study sample 94 patients were enrolled in the study and were divided into three different groups. Group 1 consisted of two consecutive groups: 27 patients who underwent cold cup bladder biopsy with electromotive intravesical lidocaine and 18 patients who underwent the same procedure without anaesthesia. Group 2 consisted of 43 patients who underwent transurethral resection using electromotive intravesical lidocaine as an Page: 1 / 5

2 alternative to general or spinal anaesthesia previously used for the procedure. Group 3 had 6 patients with benign prostatic hyperplasia or prostatic carcinoma who also underwent transurethral resection. Power calculations were not used to determine sample size. Study design The evaluation of patients in group 1 was carried out by means of a non randomised trial with historical controls. Groups 2 and 3 were evaluated in cohort studies. All studies were conducted in a single centre. The duration of follow up was until recovery period immediately following surgery. There was no loss to follow up. Analysis of effectiveness The analysis of effectiveness was based on intention to treat. The primary health outcomes used were pain before, during and after the procedure assessed using a published 11-point scale, and comfort rated on a scale of one to 10. The incidence of adverse events and willingness of patients to undergo repeat procedures using the same method of anaesthesia were also recorded. At analysis patients in group 1 were shown to have similar demographic and clinical characteristics. Effectiveness results In group 1 pain levels were significantly less in the electromotive lidocaine group during cystoscope insertion: median pain score 0 (inter quartile range: 0-2) versus 2 (inter quartile range: 1-5) in the control group, (p<0.01); during biopsy 0 (inter quartile range: 0-1.3) versus 3 (inter quartile range: 2-5), (p<0.0001); and in coagulation 0 (inter quartile range: 0-1.4) versus 2 (inter quartile range: 0-4.4), (p<0.04). 85% of patients in group 2 (electromotive lidocaine) were willing to repeat the procedure they had undergone compared with only 23% in the control group, (p<0.0002). Patients in group 2 had median pain scores of 0 except for during cut, where median scores were % of patients were willing to repeat the procedure, (p<0.0002). Of the 6 patients in group 3, the three patients who underwent bladder procedures had relatively pain free procedures, compared with the three who underwent transurethral prostatic resection with iontophoresis. Lidocaine treatment was observed to be safe, with only one adverse event of note occurring. Clinical conclusions Electromotive lidocaine is a safe and effective form of anaesthesia. Measure of benefits used in the economic analysis The clinical analysis demonstrated that electromotive intravesical lidocaine treatment was at least as effective as conventional general or spinal anaesthesia, and therefore the economic analysis was based on the difference in costs only. Direct costs Costs associated with the procedures, including time, drugs and capital equipment and disposables used were included in the analysis. These data were collected using a standardised form for each patient. It was assumed that the electric generator would be used for at least 100 procedures. The costs associated with general and spinal anaesthesia were estimated using typical charges for an anaesthetist; typical expenditures in the operating room as well as use of medication and post-operative monitoring. In the economic analysis it was assumed that all of these charges for general and spinal surgery would be avoided using iontophoresis. Anaesthesiologist charges were obtained from the provincial ministry of health schedule of benefits, and medication costs from the hospital pharmacy. Other expenses, such as Page: 2 / 5

3 intravenous sets, electrocardiogram leads and paper records were assumed to be similar in both groups and were excluded from the analysis. Costs were determined from the perspective of the provincial ministry of health. The date of the price data was Costs were not discounted, which was appropriate given the short duration of the study. Statistical analysis of costs No statistical analysis was reported. Indirect Costs Indirect costs were not included. Currency Canadian dollars (Can$). Sensitivity analysis No sensitivity analysis was conducted. Estimated benefits used in the economic analysis Not applicable. Cost results The total costs of the electromotive lidocaine procedure were estimated to be Can$286, compared with total costs for the same procedures using general or spinal therapy of Can$432. Synthesis of costs and benefits Not applicable. Authors' conclusions The provision of anaesthesia using electromotive intravesical lidocaine for patients requiring bladder operations is a safe and effective procedure, and appears to be less costly compared with that for most patients treated using a general or spinal anaesthetic. CRD COMMENTARY - Selection of comparators A justification was provided for most of the comparators used, as general and spinal anaesthesia is commonly used in bladder procedures such as biopsy and transurethral resection. Another comparator used, was no anaesthesia, but it is not clear how common such an approach is in bladder biopsy. You, as a user of the database, must consider whether this is appropriate in your own setting. Validity of estimate of measure of benefit Effectiveness data were based on a non-randomised cohort study, which did not determine sample size using power calculations. The comparator group used in this part of the study did not receive any anaesthetic. This type of study increases the possibility of bias in study results, particularly as there was no direct comparator used for groups 2 and 3; instead patients compared the intervention with their previous experiences using other forms of anaesthesia. The study sample appears to have been representative of the study population and, in group 1, patients were shown to be comparable at analysis. The economic analysis was based on an analysis of costs only, as the intervention was shown (or assumed) to be at least as effective as the comparators. Page: 3 / 5

4 Validity of estimate of costs The authors stated that the economic analysis had been conducted from a societal perspective, but, in fact, the analysis appears to have been conducted from the perspective of the provincial ministry of health, and no additional costs such as those associated with lost productivity were included in the analysis. The authors noted that some costs were assumed to be similar in both groups, and were excluded from the analysis. It is unlikely that these omissions would affect the authors' conclusions. Costs and quantities used were not reported separately. Resource use for the intervention was taken from data collected during the clinical study, resource use for alternative forms of anaesthesia were estimated based on previous typical experience. Prices were taken from the authors setting and from published sources. No sensitivity analysis of resource consumption or prices was conducted; such an analysis would have helped to determine the robustness of the study's conclusions. The paper did provide a base year for prices, although it is unclear when the actual clinical analysis took place, and it appears that charges were used to proxy prices. The economic analysis also assumed that patients who could not successfully be treated using electromotive lidocaine would be switched to conventional therapy without difficulty. The authors noted, however, that their analysis did not include the costs of any adverse events associated with this. Other issues The authors did not cite any other studies that have undertaken similar work, with the exception of one animal study which also suggested a reduced diffusion of lidocaine in the prostate. It is unclear whether any economic studies have been performed. The authors noted that their cost estimates were not generalisable and that costs may vary in different settings. The authors appear to have presented their results selectively as they do not provide information on the demographic or clinical characteristics, and detailed outcomes for patients in group 3. The authors noted that their study was also limited by difficulties in costing the waiting time required for lidocaine therapy to diffuse. Implications of the study Within the limitations described above, the findings of the study support the use of electromotive intravesical lidocaine from both clinical and economic perspectives. Source of funding Supported by Physion Srl, Mirandola, Italy. Bibliographic details Jewett M A, Valiquette L, Sampson H A, Katz J, Fradet Y, Redelmeier D A. Electromotive drug administration of lidocaine as an alternative anesthesia for transurethral surgery. Journal of Urology 1999; 161(2): PubMedID Indexing Status Subject indexing assigned by NLM MeSH Aged; Anesthetics, Local /administration & dosage; Female; Humans; Iontophoresis; Lidocaine /administration & dosage; Male; Middle Aged; Urethra; Urinary Bladder Diseases /surgery; Urologic Surgical Procedures /methods AccessionNumber Date bibliographic record published 31/08/2001 Page: 4 / 5

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