Is the combination of epidural clonidine–levobupivacaine has same analgesic efficacy and safety as the combination fentanyl–levobupivacaine after radical cystectomy?

Objective
This study was conducted to compare the efficacy and safety of addition of two drugs; clonidine versus fentanyl to epidural levobupivacaine to control postoperative pain after radical cystectomy surgery.
Patients and Methods
All urinary bladder cancer patients of both sex, ASA I and II, 40–70 years undergoing radical cystectomy surgery in National Cancer Institute (NCI) from November 2011 till May 2012 are the target group of which 50 patients accepted to share in the study, they are randomly classified by permuted block technique into two groups; group C (clonidine) who received 6 ml of levobupivacaine 0.25% + clonidine 75 μg epidural bolus dose followed by continuous epidural infusion of levobupivacaine 0.125% + clonidine 2 μg/ml at a total rate of 6–10 ml/h, and group F (fentanyl) who received 6 ml of levobupivacaine 0.25% + fentanyl 50 μg bolus dose followed by continuous epidural infusion of levobupivacaine 0.125% + fentanyl 2 μg/ml at a total rate of 6–10 ml/h. Paracetamol 1 g IV infusion was used as a rescue pain treatment. In both groups epidural activation is done after complete recovery from balanced general anesthesia. In both groups we measured vital signs (HR, MBP, RR), 0–10 visual analogue scale (VAS) and Sedation using the four-point Ramsay Sedation Scale are assessed for first 24 h postoperatively. In addition we recorded the total 24 h rescue paracetamol dose needed and side effects of both drugs were also observed.
Results
We found that there is no statistical significant difference between both groups in the vital signs (HR, MBP, and RR), analgesic efficacy (VAS), and Sedation effects (Sedation Scale), and all data were within clinically accepted range. There was no statistically significant difference in total 24 h paracetamol rescue dose needed in both groups with the same range (1–3 g/24 h) and same median value (2 g/24 h). Recorded side effects were minimal and insignificant in both groups.
Conclusion
We concluded that both clonidine and fentanyl can be used as effective additive to epidural levobubivacaine for postoperative analgesia after radical cystectomy with no significant difference between them in vital signs, analgesic, sedative effects and safety profile on adding each of them in doses not exceeding 20 μg/h to epidural continuous levobupivacaine infusion.