drugset / Trial / NCT04300231

Thoracic Epidural Analgesia Versus Rectus Sheath Block Versus Surgeon Infiltration With Liposomal Bupivacaine or Standard Bupivacaine for Post-Operative Pain Control After Cystectomy

Phase 3 Completed 160 enrolled Indiana University

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to compare the difference between four different pain control methods in patients who will be having a cystectomy surgery (surgical removal of the bladder).

Timeline

Start: 2019-10-22
Primary completion: 2021-12-23
Completion: 2021-12-24

Publications

Background Butterworth Iv, John F., David C. Mackey, and John D. Wasnick.
Background de Boer, H. D., O. Detriche, and P. Forget.
Background Guo, Q., R. Li, L. Wang, D. Zhang, and Y. Ma.
Background Hou, X., Z. Luo, H. Wang, Y. Zhan, L. Yang, and L. Li.
Background Kalogera, E., J. N. Bakkum-Gamez, A. L. Weaver, J. P. Moriarty, B. J. Borah, C. L. Langstraat, C. J. Jankowski, et al.
Background Ladjevic N, Likic-Ladjevic I, Dzamic Z, Acimovic M, Dragicevic D, Durutovic O. Combined general and epidural anaesthesia versus general anaesthesia for radical cystectomy. Acta Chir Iugosl. 2007;54(4):89-91. doi: 10.2298/aci0704089l.
Background Mazul-Sunko B, Gilja I, Jelisavac M, Kozul I, Troha D, Osmancevic N, El-Saleh A, Markic A, Kovacevic M, Bokarica P. Thoracic epidural analgesia for radical cystectomy improves bowel function even in traditional perioperative care: a retrospective study in eighty-five patients. Acta Clin Croat. 2014 Sep;53(3):319-25.
Background Ozyuvaci E, Altan A, Karadeniz T, Topsakal M, Besisik A, Yucel M. General anesthesia versus epidural and general anesthesia in radical cystectomy. Urol Int. 2005;74(1):62-7. doi: 10.1159/000082712.
Background ozek, J. J., M. De Ruyter, and T. W. Khan.
Background Sun, J. X., K. Y. Bai, Y. F. Liu, G. Du, Z. H. Fu, H. Zhang, J. H. Yang, et al.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Bupivacaine	Other / unclassified	0.05 %	Other
Comparator	Bupivacaine	Other / unclassified	0.125 %	Other
Comparator	Bupivacaine	Other / unclassified	0.5 %	Other
Comparator	Bupivacaine	Other / unclassified	20 ml	Other
Comparator	Bupivacaine	Other / unclassified	40 ml	Other
Comparator	Bupivacaine	Other / unclassified	60 ml	Other
Comparator	Hydromorphone	Other / unclassified	0.05 mg/ml	Other

Indications

No indication recorded.