drugset / Trial / NCT02647047
Spinal Versus Epidural Analgesia in Laparotomic Liver Surgery
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the efficacy of spinal analgesia for minor laparotomic hepatectomy compared with epidural analgesia, monitoring visual analog scale (VAS). The investigators expect at least the same post-operative pain control in the two groups (non inferiority of pain control with spinal analgesia compared to epidural analgesia). Second endpoint is to verify whether after spinal analgesia there is a decrease in patient's length of hospitalization according to enhanced recovery after surgery (ERAS) principles.
Timeline
- Start
- 2016-01
- Primary completion
- 2016-11
- Completion
- 2016-12
Publications
- Background Tzimas P, Prout J, Papadopoulos G, Mallett SV. Epidural anaesthesia and analgesia for liver resection. Anaesthesia. 2013 Jun;68(6):628-35. doi: 10.1111/anae.12191.
- Background Revie EJ, Massie LJ, McNally SJ, McKeown DW, Garden OJ, Wigmore SJ. Effectiveness of epidural analgesia following open liver resection. HPB (Oxford). 2011 Mar;13(3):206-11. doi: 10.1111/j.1477-2574.2010.00274.x.
- Background Kasivisvanathan R, Abbassi-Ghadi N, Prout J, Clevenger B, Fusai GK, Mallett SV. A prospective cohort study of intrathecal versus epidural analgesia for patients undergoing hepatic resection. HPB (Oxford). 2014 Aug;16(8):768-75. doi: 10.1111/hpb.12222. Epub 2014 Jan 28.
- Background Ntinas A, Kardassis D, Konstantinopoulos I, Kottos P, Manias A, Kyritsi M, Zilianiaki D, Vrochides D. Duration of the thoracic epidural catheter in a fast-track recovery protocol may decrease the length of stay after a major hepatectomy: a case control study. Int J Surg. 2013;11(9):882-5. doi: 10.1016/j.ijsu.2013.07.014. Epub 2013 Aug 4.
- Background Koea JB, Young Y, Gunn K. Fast track liver resection: the effect of a comprehensive care package and analgesia with single dose intrathecal morphine with gabapentin or continuous epidural analgesia. HPB Surg. 2009;2009:271986. doi: 10.1155/2009/271986. Epub 2009 Dec 15.
- Background Hughes MJ, McNally S, Wigmore SJ. Enhanced recovery following liver surgery: a systematic review and meta-analysis. HPB (Oxford). 2014 Aug;16(8):699-706. doi: 10.1111/hpb.12245. Epub 2014 Mar 24.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ropivacaine | Other / unclassified | 0.2 % | Other |
| Subject | Ropivacaine | Other / unclassified | 0.375 % | Other |
| Subject | Ropivacaine | Other / unclassified | 0.75 % | Other |
| Subject | Ropivacaine | Other / unclassified | 10 ml | Other |
| Subject | Ropivacaine | Other / unclassified | 20 ml | Other |
| Subject | Ropivacaine | Other / unclassified | 99 ml | Other |
| Comparator | Sufentanil | Other / unclassified | 50 ug/ml | Other |
| Comparator | Sufentanil | Other / unclassified | 1 ml | Other |
| Background | Acetaminophen | Small molecule | 1000 mg | Intravenous |
| Background | Ketorolac | Other / unclassified | 30 mg | — |