drugset / Trial / NCT04562610
Enhanced Recovery After Surgery in Orthopaedic Spine Surgery
RandomizedParallel-groupSingle-blindTreatment
Summary
This study aims to determine the impact and effect of enhanced recovery after surgery (ERAS) principles in the recovery and rehabilitation of patients following elective orthopaedic spine surgery with a specific emphasis on oral versus intravenous preoperative medication administration and the resultant cost differences.
Timeline
- Start
- 2020-11-18
- Primary completion
- 2024-10-09
- Completion
- 2024-10-09
Publications
- Background Kehlet H. Multimodal approach to control postoperative pathophysiology and rehabilitation. Br J Anaesth. 1997 May;78(5):606-17. doi: 10.1093/bja/78.5.606.
- Background Ljungqvist O, Scott M, Fearon KC. Enhanced Recovery After Surgery: A Review. JAMA Surg. 2017 Mar 1;152(3):292-298. doi: 10.1001/jamasurg.2016.4952.
- Background Carli F. Physiologic considerations of Enhanced Recovery After Surgery (ERAS) programs: implications of the stress response. Can J Anaesth. 2015 Feb;62(2):110-9. doi: 10.1007/s12630-014-0264-0. Epub 2014 Dec 12.
- Background Wainwright TW, Immins T, Middleton RG. Enhanced recovery after surgery (ERAS) and its applicability for major spine surgery. Best Pract Res Clin Anaesthesiol. 2016 Mar;30(1):91-102. doi: 10.1016/j.bpa.2015.11.001. Epub 2015 Nov 23.
- Background Starks I, Wainwright TW, Lewis J, Lloyd J, Middleton RG. Older patients have the most to gain from orthopaedic enhanced recovery programmes. Age Ageing. 2014 Sep;43(5):642-8. doi: 10.1093/ageing/afu014. Epub 2014 Mar 13.
- Background Aasvang EK, Luna IE, Kehlet H. Challenges in postdischarge function and recovery: the case of fast-track hip and knee arthroplasty. Br J Anaesth. 2015 Dec;115(6):861-6. doi: 10.1093/bja/aev257. Epub 2015 Jul 25.
- Background Marquez-Lara A, Nandyala SV, Fineberg SJ, Singh K. Current trends in demographics, practice, and in-hospital outcomes in cervical spine surgery: a national database analysis between 2002 and 2011. Spine (Phila Pa 1976). 2014 Mar 15;39(6):476-81. doi: 10.1097/BRS.0000000000000165.
- Background Martin BI, Mirza SK, Spina N, Spiker WR, Lawrence B, Brodke DS. Trends in Lumbar Fusion Procedure Rates and Associated Hospital Costs for Degenerative Spinal Diseases in the United States, 2004 to 2015. Spine (Phila Pa 1976). 2019 Mar 1;44(5):369-376. doi: 10.1097/BRS.0000000000002822.
- Background Ortman, Jennifer M, Velkoff, Victoria A, Hogan H. An Aging Nation: The Older Population in the United States. Washington DC; 2014.
- Background Smith J, Probst S, Calandra C, Davis R, Sugimoto K, Nie L, Gan TJ, Bennett-Guerrero E. Enhanced recovery after surgery (ERAS) program for lumbar spine fusion. Perioper Med (Lond). 2019 May 28;8:4. doi: 10.1186/s13741-019-0114-2. eCollection 2019.
- Background Corniola MV, Debono B, Joswig H, Lemee JM, Tessitore E. Enhanced recovery after spine surgery: review of the literature. Neurosurg Focus. 2019 Apr 1;46(4):E2. doi: 10.3171/2019.1.FOCUS18657.
- Background Angus M, Jackson K, Smurthwaite G, Carrasco R, Mohammad S, Verma R, Siddique I. The implementation of enhanced recovery after surgery (ERAS) in complex spinal surgery. J Spine Surg. 2019 Mar;5(1):116-123. doi: 10.21037/jss.2019.01.07.
- Background Elsarrag M, Soldozy S, Patel P, Norat P, Sokolowski JD, Park MS, Tvrdik P, Kalani MYS. Enhanced recovery after spine surgery: a systematic review. Neurosurg Focus. 2019 Apr 1;46(4):E3. doi: 10.3171/2019.1.FOCUS18700.
- Background de Castro SM, van den Esschert JW, van Heek NT, Dalhuisen S, Koelemay MJ, Busch OR, Gouma DJ. A systematic review of the efficacy of gum chewing for the amelioration of postoperative ileus. Dig Surg. 2008;25(1):39-45. doi: 10.1159/000117822. Epub 2008 Feb 21.
- Background Ali ZS, Ma TS, Ozturk AK, Malhotra NR, Schuster JM, Marcotte PJ, Grady MS, Welch WC. Pre-optimization of spinal surgery patients: Development of a neurosurgical enhanced recovery after surgery (ERAS) protocol. Clin Neurol Neurosurg. 2018 Jan;164:142-153. doi: 10.1016/j.clineuro.2017.12.003. Epub 2017 Dec 8.
- Background Bilku DK, Dennison AR, Hall TC, Metcalfe MS, Garcea G. Role of preoperative carbohydrate loading: a systematic review. Ann R Coll Surg Engl. 2014 Jan;96(1):15-22. doi: 10.1308/003588414X13824511650614.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Acetaminophen | Small molecule | 1000 mg | Intravenous |
| Comparator | Tranexamic Acid | Small molecule | 2 g | Intravenous |
| Comparator | Celecoxib | Other / unclassified | 200 mg | Oral |
| Comparator | Gabapentin | Small molecule | 600 mg | Oral |