drugset / Trial / NCT03007121
Intrathecal Morphine Analgesia vs. Continuous Epidural Analgesia vs. Systemic Analgesia in Colorectal Surgery.
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to determine which postoperative analgesia is optimal after colorectal surgery. The investigators will compare intrathecal morphine, continuous epidural analgesia and standard systemic analgesia. All patients will have the possibility to administer themselves intravenous morphine as needed.
Timeline
- Start
- 2017-04-10
- Primary completion
- 2018-12-14
- Completion
- 2018-12-17
Publications
- Background Devys JM, Mora A, Plaud B, Jayr C, Laplanche A, Raynard B, Lasser P, Debaene B. Intrathecal + PCA morphine improves analgesia during the first 24 hr after major abdominal surgery compared to PCA alone. Can J Anaesth. 2003 Apr;50(4):355-61. doi: 10.1007/BF03021032. English, French.
- Background Beaussier M, Weickmans H, Parc Y, Delpierre E, Camus Y, Funck-Brentano C, Schiffer E, Delva E, Lienhart A. Postoperative analgesia and recovery course after major colorectal surgery in elderly patients: a randomized comparison between intrathecal morphine and intravenous PCA morphine. Reg Anesth Pain Med. 2006 Nov-Dec;31(6):531-8. doi: 10.1016/j.rapm.2006.06.250.
- Background Sakowska M, Docherty E, Linscott D, Connor S. A change in practice from epidural to intrathecal morphine analgesia for hepato-pancreato-biliary surgery. World J Surg. 2009 Sep;33(9):1802-8. doi: 10.1007/s00268-009-0131-2.
- Background Virlos I, Clements D, Beynon J, Ratnalikar V, Khot U. Short-term outcomes with intrathecal versus epidural analgesia in laparoscopic colorectal surgery. Br J Surg. 2010 Sep;97(9):1401-6. doi: 10.1002/bjs.7127.
- Background Levy BF, Scott MJ, Fawcett W, Fry C, Rockall TA. Randomized clinical trial of epidural, spinal or patient-controlled analgesia for patients undergoing laparoscopic colorectal surgery. Br J Surg. 2011 Aug;98(8):1068-78. doi: 10.1002/bjs.7545. Epub 2011 May 17.
- Background Werawatganon T, Charuluxananan S. WITHDRAWN: Patient controlled intravenous opioid analgesia versus continuous epidural analgesia for pain after intra-abdominal surgery. Cochrane Database Syst Rev. 2013 Mar 28;2013(3):CD004088. doi: 10.1002/14651858.CD004088.pub3.
- Background Rodgers A, Walker N, Schug S, McKee A, Kehlet H, van Zundert A, Sage D, Futter M, Saville G, Clark T, MacMahon S. Reduction of postoperative mortality and morbidity with epidural or spinal anaesthesia: results from overview of randomised trials. BMJ. 2000 Dec 16;321(7275):1493. doi: 10.1136/bmj.321.7275.1493.
- Background Rigg JR, Jamrozik K, Myles PS, Silbert BS, Peyton PJ, Parsons RW, Collins KS; MASTER Anaethesia Trial Study Group. Epidural anaesthesia and analgesia and outcome of major surgery: a randomised trial. Lancet. 2002 Apr 13;359(9314):1276-82. doi: 10.1016/S0140-6736(02)08266-1.
- Background Manion SC, Brennan TJ. Thoracic epidural analgesia and acute pain management. Anesthesiology. 2011 Jul;115(1):181-8. doi: 10.1097/ALN.0b013e318220847c. No abstract available.
- Background Moen V, Dahlgren N, Irestedt L. Severe neurological complications after central neuraxial blockades in Sweden 1990-1999. Anesthesiology. 2004 Oct;101(4):950-9. doi: 10.1097/00000542-200410000-00021.
- Background Meylan N, Elia N, Lysakowski C, Tramer MR. Benefit and risk of intrathecal morphine without local anaesthetic in patients undergoing major surgery: meta-analysis of randomized trials. Br J Anaesth. 2009 Feb;102(2):156-67. doi: 10.1093/bja/aen368.
- Background De Pietri L, Siniscalchi A, Reggiani A, Masetti M, Begliomini B, Gazzi M, Gerunda GE, Pasetto A. The use of intrathecal morphine for postoperative pain relief after liver resection: a comparison with epidural analgesia. Anesth Analg. 2006 Apr;102(4):1157-63. doi: 10.1213/01.ane.0000198567.85040.ce.
- Background Holte K, Kehlet H. Epidural analgesia and risk of anastomotic leakage. Reg Anesth Pain Med. 2001 Mar-Apr;26(2):111-7. doi: 10.1053/rapm.2001.21241.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bupivacaine | Other / unclassified | 0.125 % | Other |
| Subject | Morphine | Other / unclassified | 0.3 mg | Intrathecal |
| Subject | Morphine | Other / unclassified | 1 mg | Intrathecal |
| Comparator | Sufentanil | Other / unclassified | 0.4 ug/ml | Other |
Indications
No indication recorded.