To compare the effect of an adjunctive postoperative epidural local anesthetic with combined lumbar spinal epidural anesthesia versus systemic nonsteroidal analgesics with general anesthesia on disease recurrence following radical prostatectomy for prostate cancer.Methods
This prospective randomized study describes an analysis of patients who underwent retropubic radical prostatectomy. We evaluated recurrence of prostate cancer after open radical prostatectomy in patients who received either combined lumber spinal epidural anesthesia with postoperative epidural analgesia (CSE group; n=30) or general anesthesia with postoperative nonsteroidal analgesia that consisted of ketorolac 30 mg intravenously every 8 h and paracetamol 1 g intravenously every 6 h over 48 h (GA group; n=30). The first dose of ketorolac was administered at the time of fascial closure. For patients in both groups, analgesic supplementation with tramadol 100 mg intramuscularly was used whenever the pain score exceeded 2/10 on the visual analogue scale. Specifically, we tested the hypothesis that recurrence of prostate cancer is less common with the CSE group than with the GA group. Follow-up chart review was performed to determine clinically evident or biochemical (prostate-specific antigen>0.4 ng/ml) recurrence of prostate cancer. Comparison by group was carried out using survival analysis.Results
The patients in the CSE group showed a significantly more stable hemodynamic profile. These patients also showed significantly less blood loss, need for blood transfusion, and also the surgical time was shorter in the patients of this group compared with those who received general anesthesia (the GA group), with the differences being statistically significant. In the postoperative period, the patients in the CSE group had a significantly shorter recovery time and less hospital stay; in addition, there was a highly significant difference in analgesic supplementation. Median disease-free survival could not be defined in either group, as less than 50% of patients in both groups developed recurrence by the end of the study. Biochemical recurrence of prostate cancer was observed in 5/30 patients in the CSE group and 8/30 patients in the GA group. There was one death because of prostate cancer in each group and a total of five deaths in the CSE group and six deaths in the GA group. The hazard ratio for recurrence in the CSE group compared with the GA group was 2.03 (95% confidence intervals 0.76–5.43; P=0.44 by the log-rank test).Conclusion
No significant difference was observed between both groups in disease-free survival at a median follow-up time of 2 years. There is a need for large randomized-controlled trials to determine the ability of combined lumber spinal epidural anesthesia with postoperative epidural analgesia to alter disease recurrence rates following radical prostatectomy.