Enhanced Recovery After Surgery in Orthopaedic Spine Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Lumbar Surgery

Intervention / Treatment
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* Drug: Intravenous Infusion group
* Drug: All oral administration group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 105 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The investigators are comparing the efficacy of commonly administered pre-emptive analgesic medications administered in a randomized fashion in parallel. In one group all medications will be administered by mouth and in one group two of the medications will be administered via the intravenous route.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A: All oral pre-operative analgesics<br>Group A patients will be administered the following medications in the preoperative holding area: Acetaminophen 1,000 mg by mouth prior to operation Celecoxib 200mg by mouth prior to operation Tranexamic acid 2 grams by mouth prior to operation Gabapentin 600mg by mouth prior to operation | Drug: All oral administration group<br>* 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.<br>|
| Active Comparator: Group B: Intravenous agents<br>Group B patients will receive: Acetaminophen (Ofirmev) 1,000mg intravenous prior to operation Celecoxib 200mg by mouth prior to operation Tranexamic acid 2grams intravenous at start of operation Gabapentin 600 mg by mouth prior to operation | Drug: Intravenous Infusion group<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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 | 
| 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) | 
| 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) | 
| 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) | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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) | 
| 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. | 
| 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. | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lumbar decompression and fusions 1 to 3 levels, lumbar decompression and fusions