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Thoracic epidural anesthesia for pain relief and postoperation recovery with modified radical mastectomy |
Yeh C C, Yu J C, Wu C T, Ho S T, Chang T M, Wong C S |
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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 Thoracic epidural anaesthesia (TEA) for modified radical mastectomy (MRM) surgery to provide postoperative pain relief and recovery. In TEA group patients, 2% lidocaine (15-20 ml) was administered via the epidural route as primary anaesthesia, in conjunction with midazolam (5-10 mg) and fentanyl (<250 micro g) for amnesia.
Type of intervention Treatment and secondary prevention.
Economic study type Cost-effectiveness analysis.
Study population The study investigated patients rated as American Society of Anesthesiologists (ASA) physical status 1 to 3, who underwent MRM surgery. Patients were excluded from the study if they had any medical contraindication for epidural anaesthesia.
Setting Hospital. The economic analysis was carried out in Taiwan.
Dates to which data relate Source of effectiveness data The evidence for the final outcomes was based on a single study.
Link between effectiveness and cost data Costing appears to have been performed on the same patient sample as that used in the effectiveness analysis, but it was not reported whether it was conducted prospectively or retrospectively.
Study sample Power calculations were not used to determine the sample size. The study sample consisted of 64 patients randomly assigned to either the GA group (n=32) with a mean (SD) age of 49.7 (3.1) years, or the TEA group (n=32) with a mean (SD) age of 47.4 (2.2) years.
Study design The study was a double-blind, randomised, controlled trial carried out in a single centre. The duration of the follow-up was 2 days after surgery. The study appears to have had no loss to follow-up. The anaesthesiologist who evaluated the postoperative conditions was not aware of the anaesthetic technique performed.
Analysis of effectiveness The principle used in the analysis of effectiveness was intention to treat. The clinical outcome measures were time to first pethidine requirement, total pethidine consumption, worst pain score, bed rest time, satisfaction score, frequency of pethidine injection for pain relief, and anaesthesia-related side effects (nausea, vomiting, dizziness, and headache) for 2 days after surgery. Pain intensity was evaluated by using a 100-mm visual analog scale (VAS), and satisfaction scores were evaluated by numeric rating scores (5 to 1, from most to least satisfaction). The pain score was recorded at the first dose of pethidine. The patient characteristics of the two study groups were comparable with respect to age, weight, ASA status, and duration of surgery.
Effectiveness results A longer time to first pethidine requirement was observed in the TEA group (19.2 +/- 1.5) than in the GA group (7.6 +/-2.5 hours) (p<0.001)
Decreased pethidine consumption was observed in the TEA group (17.2 +/- 7.0) compared with the GA group (76.3 +/- 17.4 mg) (p<0.001)
A worse visual analog scale (VAS) pain score was observed in the GA group (5.7 +/- 0.6) than in the TEA patients (4.3 +/- 0.4) (p<0.01).
The average bed rest time was significantly shorter in the TEA group (16.9 +/- 0.0 hours) (p<0.01) than in the GA group (27.1 +/- 4.1 hours).
Overall satisfaction scores were significantly higher in the TEA group (4.4 +/- 0.1) (p<0.01) than in the GA group (3.5 +/- 0.2).
Side effects were observed at a higher frequency in the GA group (16/32), (p<0.0001) than in the TEA group (3/32).
The frequency of pethidine injection for pain relief was significantly lower in the TEA group (8/32), (p<0.0001) than in the GA group (24/32).
Clinical conclusions The results show that TEA provided a more prolonged analgesic effect than GA after MRM operation. It appears that there are some clinical advantages of using epidural anaesthesia rather than GA. The study found that TEA provided better pain relief, greater satisfaction, early ambulation, and fewer side effects than GA following major breast surgery.
Measure of benefits used in the economic analysis No summary benefit measure was identified in the economic analysis, and only individual clinical outcomes were reported.
Direct costs Costs were not discounted due to the short time frame of the cost analysis. Some quantities were reported separately from the costs and some cost items were reported separately. The cost analysis covered the costs of anaesthesia and hospital. The perspective adopted in the cost analysis was not explicitly specified. The price year was not explicitly reported.
Statistical analysis of costs Student's t test was used to compare the study groups in terms of costs.
Indirect Costs Indirect costs were not considered.
Currency New Taiwan dollars (NT). The ratio to the US dollar was reported to be approximately 1.00:33.60.
Sensitivity analysis No sensitivity analysis was carried out.
Estimated benefits used in the economic analysis The reader is referred to the effectiveness results reported above.
Cost results Both the total hospital cost (NT 64,392 +/- 3,523 versus NT 53,806 +/- 2,817), (p=0.0342), and the anaesthesia cost (NT 7,968 +/- 246 versus NT 5,268 +/- 262) (p=0.0001) were significantly lower in the TEA group than the GA group.
Synthesis of costs and benefits Costs and benefits were not combined as the use of TEA was, in fact, the dominant strategy.
Authors' conclusions TEA provided better postoperative pain relief and recovery, and lower cost than GA for MRM surgery.
CRD COMMENTARY - Selection of comparators A justification was given for the choice of the comparator, which was deemed to be the usual method adopted in the context in question. You, as a database user, should consider whether this is the case in your own setting.
Validity of estimate of measure of effectiveness The effectiveness results are likely to be internally valid given the double-blind, randomised nature of the study design, the comparability of the study groups, and the intention to treat basis for the analysis. However, the lack of power analysis to justify the sample size may have weakened the internal validity of the results. The study sample appears to have been representative of the study population.
Validity of estimate of measure of benefit The authors did not derive a measure of health benefit. The economic analysis was therefore of cost-consequences design.
Validity of estimate of costs The following limitations of the cost analysis may have adversely affected its validity: the price year and the perspective adopted in the cost analysis were not specified; cost and resource use profile were not reported in detail; it was not clear whether the costing was conducted retrospectively or prospectively or whether it was based on charges or true costs; the effects of the alternative modalities on indirect costs (productivity loss) were not addressed; the cost results may not be generalisable outside the study setting. Statistical analysis was appropriately performed on some resource use and cost data.
Other issues The authors' conclusions appear to be justified given the uncertainties in the data. The issue of generalisability to other settings or countries was not addressed, although appropriate comparisons were made with other studies. The issue of the degree to which the study sample was representative of the study population was not addressed in the authors' comments.
Implications of the study Thoracic epidural anaesthesia has been used in many clinical situations because of its potential benefits. Experience with high TEA is limited. The study results may not be conclusive, although the study did find that TEA with the use of sedatives can facilitate MRM surgery and is associated with lower costs and better health outcomes.
Source of funding Grants from the National Science Council (NSC-86-2314-B-016-071) and National Health Research Institute (DOH86-HR-402) of Taiwan, Republic of China.
Bibliographic details Yeh C C, Yu J C, Wu C T, Ho S T, Chang T M, Wong C S. Thoracic epidural anesthesia for pain relief and postoperation recovery with modified radical mastectomy. World Journal of Surgery 1999; 23(3): 256-261 Indexing Status Subject indexing assigned by NLM MeSH Analgesics, Opioid /administration & Anesthesia, Epidural /economics; Breast Neoplasms /surgery; Breast Neoplasms, Male /surgery; Chi-Square Distribution; Double-Blind Method; Female; Hospital Costs; Humans; Male; Mastectomy, Modified Radical /adverse effects; Meperidine /administration & Middle Aged; Monitoring, Intraoperative; Pain Measurement; Pain, Postoperative /prevention & Thorax; control; dosage; dosage AccessionNumber 21999000371 Date bibliographic record published 31/07/2001 Date abstract record published 31/07/2001 |
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