Cost-effectiveness analysis of levobupivacaine 0.5 %, a local anesthetic, infusion in the surgical wound after modified radical mastectomy.

BACKGROUND AND OBJECTIVE: Effective treatment of postoperative pain contributes to decreasing the rate of complications as well as the total cost of the operated patients. The aim of this study was to analyze the costs and the efficiency of use of continuous infusion of levobupivacaine 0.5 % with the help of an infusion pump in modified radical mastectomy. METHODS: A cost calculation of the analgesic procedures (continuous infusion of levobupivacaine 0.5 % [levobupivacaine group (LG)] or saline [saline group (SG)] (2 ml/h 48 h) has been carried out based on the data of a previous clinical trial (double-blind randomized study) of patients who underwent modified radical mastectomy surgery. The measure of the effectiveness was the point reduction of pain derived from the verbal numeric rating scale (VNRS). The usual incremental cost-effectiveness ratio (ICER) was performed. RESULTS: Considering only the intravenous analgesia, overall costs were lower in LG, as less analgesia was used (EUR14.06 ± 7.89 vs. 27.47 ± 14.79; p < 0.001). In this study the costs of the infusion pump were not calculated as it was used by both groups and they offset each other. However, if the infusion pump costs were included, costs would be higher in the LG, (EUR91.89 ± 7.89 vs. 27.47 ± 14.79; p < 0.001) and then the ICER was -8.51, meaning that for every extra point of decrease in the pain verbal numerical rating score over the 2-day period, the cost increased by EUR8.51. CONCLUSION: Infiltration of local anesthetics is an effective technique for controlling postoperative pain and the associated added costs are relatively low in relation to the total cost of mastectomy, therefore providing patients with a higher quality of care in the prevention of pain. CLINICAL TRIALS REGISTRATION: clinicaltrials.gov: reference number NCT01389934. http://clinicaltrials.gov/show/NCT01389934

Postoperative analgesia by infusion of local anesthetic into the surgical wound after modified radical mastectomy: a randomized clinical trial.

BACKGROUND: There is no consensus on the efficacy of postoperative infusion of local anesthetics after radical mastectomy. METHODS: A randomized, double-blind, placebo-controlled, parallel-groups clinical trial was conducted in a tertiary hospital. Eighty consecutive women with operable breast cancer with indications for modified radical mastectomy without breast reconstruction were assigned randomly to receive infusion of levobupivacaine (0.5%) or saline at 2 ml/hour for 48 hours through a wound catheter. Seventy-three women finished the study (intervention group, n = 34; control group, n = 39). During surgery, all patients received 0.25% levobupivacaine (30 ml). RESULTS: The levobupivacaine group reported less pain (p < 0.001) than controls in the postanesthesia care unit (1.6 ± 1.3 versus 6.7 ± 1.8) and on the ward at 24 (0.8 ± 0.9 versus 4.2 ± 1.9) and 48 (0.4 ± 0.7 versus 3.3 ± 2.3) hours. In the postanesthesia care unit, the levobupivacaine group consumed less metamizole (0.4 ± 0.5 versus 0.8 ± 0.4; p < 0.001) and dexketoprofen (0.1 ± 0.3 versus 0.7 ± 0.4; p < 0.001), with differences in paracetamol use being insignificant (0.8 ± 0.4 versus 0.9 ± 0.3; p = 0.140). On the ward, the levobupivacaine group used significantly less paracetamol (0.5 ± 0.7 versus 2.0 ± 2.0; p < 0.001) and metamizole (0.2 ± 0.4 versus 1.2 ± 1.4; p < 0.001), but differences in dexketoprofen were not significant (0.03 ± 0.2 versus 0.2 ± 0.6; p = 0.074). In the postanesthesia care unit, the levobupivacaine and control groups consumed 0 ± 0 and 0.7 ± 1.2 doses of opioids (p = 0.001), respectively. The authors observed no differences in nausea and vomiting at any stage in the postanesthesia care unit (0.2 ± 0.4 versus 0.4 ± 0.5; p = 0.081) or on the ward (0.3 ± 0.5 versus 0.4 ± 0.5; p = 0.563). All participants reported high levels of satisfaction. CONCLUSION: Continuous infusion of local anesthetic reduces pain and analgesic consumption, with high satisfaction, but does not affect rates of nausea and vomiting.