Enhanced Recovery After Surgery in Orthopaedic Spine Surgery

Lumbar Surgery Clinical Trial

— ERAS  

Official title:

A Prospective Study of Enhanced Recovery After Surgery in Orthopaedic Spine Surgery: Administration of Preoperative Oral Versus Intravenous Medications

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04562610
• Other study ID #: 1586560
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: November 18, 2020
• Est. completion date: June 15, 2024

Study information

• Verified date: June 2023
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

In orthopaedic surgery, ERAS programs have profoundly impacted outcomes in hip and knee replacement surgery.4 Large, prospective studies have demonstrated a reduction in mortality rate, median length of stay, and blood transfusion rates with no change in re-admission rates.5,6 However, there is a paucity of data evaluating the application of ERAS principles in other orthopaedic subspecialties, especially elective spine surgery. With over 35,000 cervical spine procedures performed in 2011, almost 200,000 elective lumbar fusion surgeries performed in 2015, and 83.7 million people estimated to be ≥ 65 years old in 2050, the demand for elective spine surgery is high and will continue to grow placing a significant economic burden on the health care system.This increasing demand in conjunction with prolonged hospital stays, extensive postoperative pain regimens, and the advent of minimally invasive procedures provides a compelling argument for the suitability of ERAS protocols in elective spine surgery.

While distinct components of the ERAS pathway have been investigated in spine surgery including preoperative education, multimodal pain management, surgical approach, nutrition, and physical therapy, few studies have investigated the collective application of these interventions. Furthermore, these studies have been retrospective in nature, limiting their generalizability.The goal of this study is to perform a prospective, randomized trial to evaluate the efficacy and cost-effectiveness of oral versus intravenous medications preoperatively. The investigators also plan to evaluate the effect of the implementation of the standard of care ERAS principles on the outcome of patients undergoing elective spine surgery.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: June 15, 2024
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 105 Years

Eligibility

Inclusion Criteria:

· Surgery scheduled for lumbar decompression and fusions 1 to 3 levels

Exclusion Criteria:

• Cervical, thoracic, or lumbar trauma

• Oncologic procedures

• Patient's with comorbidities preventing early postoperative mobilization

• Patients with contraindications to tranexamic acid (TXA) administration including but not limited to patients with a history of thromboembolic or ischemic events (PE, DVT, CVA, MI). Additional contraindications are decided by treating orthopaedic surgeon

Related Conditions & MeSH terms

• Lumbar Surgery

Intervention

Drug:
• Intravenous Infusion group
The intravenous infusion group will receive two medications via the intravenous infusion route. These medications are Ofirmev ( acetaminophen ) 1,000mg and tranexamic acid 2,000 mg , an antifibrinolytic drug. In addition to these drugs, study subjects will receive Celecoxib 200mg by mouth and Gabapentin 600 mg by mouth prior to operation.
• All oral administration group
Subjects in the oral administration group will receive the following pre-emptive analgesic drugs, acetaminophen 1,000mg, Celecoxib 200mg and gabapentin 600mg via the oral route prior to operation. In addition they will receive the antifibrinolytic drug, tranexamic acid 2,000mg via an oral route as well prior to operation.

Locations

Country	Name	City	State
United States	University of California Davis Medical Center	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

References & Publications (16)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Ortman, Jennifer M, Velkoff, Victoria A, Hogan H. An Aging Nation: The Older Population in the United States. Washington DC; 2014.

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operative blood loss (ml)	Actual or estimated blood loss during operation. This is typically included in the surgeons operative note.	From incision start to wound closed. 0-6 hours after operation start.
Primary	Postoperative pain scores (VAS) Visual analog scale.	Visual analog pain score from 1-10 points reported by patient with 10 severe pain and 0 being no pain. The investigators are comparing the efficacy of two different analgesia regimens, this is a critical primary outcome measure.	The investigators will measure change between baseline/pre-surgical VAS score to immediate post surgical VAS, and at 4 hour intervals until hospital discharge. 0-48 hours
Primary	Immediate postoperative opiate analgesic requirement	Immediate post procedure Opiate analgesic requirement measured in Morphine equivalents (mg)	From post anesthesia care unit admission until hospital discharge. As the investigators are measuring the 24 hour Morphine equivalent dosing from anesthesia emergence until hospital discharge. ( 0-48 hours after operation)
Primary	Time from post-anesthesia care unit (PACU) admission to discharge	This is the time from anesthesia emergence to initiation of meaningful activity. and recovery measured from anesthetic (in hours) with a range of 1-12 hours.	PACU admission to PACU discharge (range 0-6 hours)
Primary	blood transfusion requirement	Amount of blood transfused expressed in milliliters (ml). As this may range from binary ( yes or no ) and could also be recorded in volume milliliters; the owill record and report both.	At any time point during hospitalization. ( 0-48 hours after operation)
Primary	Length of hospital stay	Length of hospital stay (LOS) in days with a range from 1-6 days.	From day of operation (day zero) through hospital discharge.Expected range 1-3 days)
Secondary	Overall cost of hospitalization.	Total cost of hospitalization including hospital stay, pharmacy charges, and other professional fees.	Admission to outpatient surgery until discharge from the hospital, range expected 6-72 hours.
Secondary	Post operative complications	This outcome will be binary (yes/no). The investigators will record the occurrence of any operative or postoperative complications from hospital admission to hospital discharge. If no complications occur these will be recorded as zero; should complications occur during hospitalization, these complication will be recorded (readmission rate, infection, wound dehiscence, return to OR, deep vein thrombosis/pulmonary embolism (DVT/PE). Intra-operative complications, postoperative complications, including but not limited to respiratory events, GI complications including ileus, postoperative nausea and vomiting, ground level falls, orthostatic hypotensive events or any complication associated with early mobilization. The number of complications will be listed in addition to the individual complication type.	From initiation of operation to hospital discharge (Day1-3)
Secondary	Oswestry Disability Index (ODI)	10 question survey instrument with domains which include pain, physical, and social function. The range of scores is from 0-100 with 0 being no disability and 100 representing bedbound patients with no capacity to function in any domain.	The investigators will measure change between baseline (ODI) and at surgical visits and 12 months after operation.
Secondary	Patient Reported Outcome Measurement Information System, Computer Adaptive Tests (PROMIS CAT)	NIH computer adapted technology patient reported outcomes measures of pain interference, physical function, depression, anxiety, and upper extremity function.	The investigators will measure change between PROMIS CAT scores between between baseline and 12 months after operation.
Secondary	University of California, Davis Short Form 20 (UCD SF-20)	Patient reported outcome instrument with 20 questions and score between range 0- 100 points. Domains surveyed include self perception of health, bodily pain, social function, physical function and role emotional health.	The investigators will measure change between baseline pre-op SF-20 scores and 12 months after operation

External Links

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