drugset / Trial / NCT02958566
Multimodal Narcotic Limited Perioperative Pain Control With Colorectal Surgery
RandomizedParallel-groupOpen-labelSupportive care
Summary
The General Objective of this study is to investigate the cost and efficacy of treating patients undergoing colorectal surgical resections with an opioid limited pain control regimen as part of an Enhanced Recovery After Surgery (ERAS) Protocol. This group will be compared to a traditional opioid based pain control regimen.
Timeline
- Start
- 2017-01
- Primary completion
- 2017-12
- Completion
- 2018-12
Publications
- Results Muller S, Zalunardo MP, Hubner M, Clavien PA, Demartines N; Zurich Fast Track Study Group. A fast-track program reduces complications and length of hospital stay after open colonic surgery. Gastroenterology. 2009 Mar;136(3):842-7. doi: 10.1053/j.gastro.2008.10.030. Epub 2008 Nov 1.
- Results Serclova Z, Dytrych P, Marvan J, Nova K, Hankeova Z, Ryska O, Slegrova Z, Buresova L, Travnikova L, Antos F. Fast-track in open intestinal surgery: prospective randomized study (Clinical Trials Gov Identifier no. NCT00123456). Clin Nutr. 2009 Dec;28(6):618-24. doi: 10.1016/j.clnu.2009.05.009. Epub 2009 Jun 17.
- Results Lubawski J, Saclarides T. Postoperative ileus: strategies for reduction. Ther Clin Risk Manag. 2008 Oct;4(5):913-7. doi: 10.2147/tcrm.s2390.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Acetaminophen | Small molecule | 600 mg | Oral |
| Subject | Bupivacaine | Other / unclassified | — | — |
| Comparator | Fentanyl | Other / unclassified | 50 ug | Intravenous |
| Comparator | Fentanyl | Other / unclassified | 75 ug | Intravenous |
| Subject | Gabapentin | Small molecule | 300 mg | Oral |
| Subject | Hydrocodone | Unknown | 5 mg | Oral |
| Subject | Hydrocodone | Unknown | 325 mg | Oral |
| Comparator | Hydromorphone | Other / unclassified | 0.5 mg | Intravenous |
| Subject | Ketamine | Small molecule | — | — |
| Subject | Ketorolac | Other / unclassified | 15 mg | Intravenous |
| Subject | Lidocaine | Other / unclassified | 1 mg/kg | — |
| Subject | Methadone | Other / unclassified | — | — |
| Comparator | Morphine | Other / unclassified | 1 mg | Intravenous |
| Comparator | Morphine | Other / unclassified | 2 mg | Intravenous |
| Subject | Orphenadrine | Small molecule | 60 mg | Intravenous |
| Subject | Tramadol | Other / unclassified | 50 mg | Oral |