Enhanced Recovery After Spine Surgery Randomized Clinical Trial

Study Overview
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Brief Summary
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The purpose of this study is to compare two different approaches to the care patients receive before, during and after their spinal surgery and to determine if either approach has a significant difference in patient outcomes, opioid use, and recovery following spine surgery. The study will compare the standard-of-care surgical approach taken at the Hospital of the University of Pennsylvania with the Enhanced Recovery After Spine Surgery (ERASS) pathway. ERASS is a program that will provide additional education before your surgery, reduce your opioid consumption, and provide earlier physical therapy than you would normally receive under the standard-of-care approach, among other protocols outlined in this consent. Patients will be randomized to receive either of these approaches and the researchers will collect information to better understand if the ERASS approach provides more patient benefits.

Official Title
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Enhanced Recovery After Spine Surgery (ERASS) Versus Traditional Spine Surgical Care (TC): A Randomized, Prospective Trial

Conditions
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ERAS

Intervention / Treatment
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* Other: ERASS Pathway


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients 18 and older (both male and female), who present to the department of neurosurgery at the Hospital of the University of Pennsylvania and who are determined to require elective spine surgery with one of two senior spine neurosurgeons, Drs. Malhotra and Marcotte. Exclusion Criteria: Patients who are pregnant Incarceration Patients under the age of 18 Patients unable to participate in the consent procedure Patients undergoing emergent surgery Patients with liver disease

Ages Eligible for Study
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Minimum Age: 18 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br> | |
| Experimental: Treatment<br> | Other: ERASS Pathway<br>* Enhanced Recovery After Spinal Surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid use during hospitalization | Total opioid use during hospitalization after surgery | post-operative days during hospital admission, up to 20 days | 
| Opioid use after surgery | Proportion of patients using opioids one month after surgery | up to one month after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Opioid Consumption During Hospitalization Using Morphine Equivalents | Total morphine equivalents for each post-operative day (POD) 0, 1, 2, 3...21+ Total morphine equivalents for all post-operative days | post-operative days during hospital admission, up to 20 days | 
| Usage of PCA during hospitalization | • Patient-controlled analgesia (PCA) use (collected mg per hour and morphine equivalent) | from admission to discharge, up to 20 days | 
| Opioid Consumption During Hospitalization | Use of intravenous (IV) narcotics (collected by Yes or No) Use of Narcan/Naloxon (collected by Yes or No) | post-operative days during hospital admission, up to 20 days | 
| Opioid Refills After Surgery | • Number of times opioid was refilled over 1 month | up to one month after surgery | 
| Opioid Prescribed After Surgery | • Medications and number of pills prescribed at discharge | up to one month after surgery | 
| Opioid Refills (days) After Surgery | • Number of days until 1st, 2nd, and 3rd refill | up to one month after surgery | 
| Opioids Left Over After Surgery | • Number of pills leftover at one-month timepoint from surgery | up to one month after surgery | 
| Opioid Compliance During Hospitalization | • Compliance with inpatient Enhanced Recovery After Surgery (ERAS) multimodal pain regimen | from admission to discharge, up to 20 days | 
| Pain Control Medication Usage | Total usage of non-opioids medication was collected by mg with the following medications: Acetaminophen Dexamethasone Lidocaine/ Lidoderm Toradol Valium Flexeril Gabapentin Pregabalin Ketamine | post-operative days during hospital admission, up to 20 days | 
| Pain Control Measurement | Using the Visual Analogue Scale (VAS), patients had to rate their pain on a scale of 1 to 10, with 1 being the least pain and 10 being the least amount of pain. Timepoints included: Preop pain score Discharge pain score Average pain score Minimum pain score Maximum pain score | from admission to discharge, up to 20 days | 
| Mobilization During Hospitalization | Collection of patient mobilization post-operative day (POD) 0, 1 Collection of patient ambulation post-operative day (POD) 0, 1 | post-operative days 0 and 1 during hospital admission | 
| Time to Mobilization During Hospitalization | • Record time to mobilization and ambulation | post-operative days during hospital admission, up to 20 days | 
| Patient Falls | • Collection of total number of inpatient falls | from admission to discharge, up to 20 days | 
| Usage of Foley During Hospitalization Course | • Collection of patient use of Foley catheter post-operatively | from admission to discharge, up to 20 days | 
| Usage of Straight Catheterization During Hospitalization Course | • Collection of patient use for straight catheterization post-operatively | from admission to discharge, up to 20 days | 
| Collection of Inpatient Status | • Collection of patient hospitalization status post-operatively including: inpatient, outpatient and observational | from admission to discharge, up to 20 days | 
| Length of Stay (days) | Total length of stay (days) in hospital Total length of stay (days) in intensive care unit (ICU) | from admission to discharge, up to 20 days | 
| Length of Stay (hours) | Total length of stay (hours) in hospital Total length of stay (hours) in intensive care unit (ICU) | from admission to discharge, up to 20 days | 
| Collection of Patient Complications | Collection of complications (Yes/No) including: Death Complications (including surgical site infection, urinary tract infections, cardiopulmonary events, wound dehiscence rates, and non-union rates, and others) Morbidities | from admission to discharge, up to 20 days and up to 6 months after surgery | 
| Collection of Patient Re-admissions After Discharge | Collection of patient re-admission 30-days after surgery Collection of patient re-admission 90-days after surgery | up to 3 months after surgery | 
| Collection of Re-operation After Surgery | • Collection of any reoperations that occurred after the patient's initial surgery | up to 3 months after surgery | 
| Discharge Follow Up Questionnaire | Measured with Yes or No, patients were asked if they completed Enhanced Recovery After Surgery (ERAS) protocols and prior to surgery. | prior to surgery, up to 2-6 weeks after discharge from the hospital | 
| Collection of Discharge Disposition | • Collection of discharge disposition following hospital discharge | from admission to discharge, up to 20 days | 
| Compliance During Hospitalization | Compliance with OR checklist Compliance with inpatient ERAS wound care regimen | from admission to discharge, up to 20 days | 
| Patient Reported Outcomes EQ-5D | Using the EQ-5D, data is collected on a scale of 1 to 3 with 1 being no problem, 2 being moderate problem and 3 being severe problem. | prior to surgery, up to 6 months after surgery | 
| Patient Reported Outcomes EQ-5D (health scale) | Using the EQ-5D, data is collected health scale for today. On a scale 0 to 100 with 100 being the best health and 0 means the worst health. | prior to surgery, up to 6 months after surgery | 
| Patient Reported Outcomes Oswestry Low Back Pain Disability Questionnaire | Using the oswestry low back pain disability index (ODI) scale, patients' responses are calculated on a scale of 0 to 100 with 0 being no pain and 100 being the worst pain. | prior to surgery, up to 6 months after surgery | 
| Patient Reported Outcomes Neck Disability Index | Using the neck pain disability index (NDI) scale, patients' responses are calculated on a scale of 0 to 100 with 0 being no pain and 100 being the worst pain. | prior to surgery, up to 6 months after surgery | 
| Patient Reported Outcomes Neurosurgery Patient Satisfaction | Using the Neurosurgery Patient Satisfaction Outcome questionnaire, patients' satisfaction are recorded with Yes or No to questions. | prior to surgery, up to 6 months after surgery | 
| Collection of Working Status | Collection of patient working status including: currently working retired disabled not working due to a reason other than the condition being treated | prior to surgery, up to 6 months after surgery | 
| Consults | • Rate of provider recommendation for additional consultations | Prior to surgery | 
| Enhanced Recovery at Penn (ERAP) Text Messaging Program - Patient Enrollment | • Patient enrollment in service | Up to 3 months after surgery | 
| Enhanced Recovery at Penn (ERAP) Text Messaging Program - Compliance | • ERAP compliance with carbohydrate loading and surgical site preparation | Up to 3 months after surgery | 
| Enhanced Recovery at Penn (ERAP) Text Messaging Program - Pain Score | • Pain scores (1 to 10 with 1 being no pain and 10 being worst) at 1, 2, and 3 weeks and at 1, 2, and 3 months postop | Up to 3 months after surgery | 
| Enhanced Recovery at Penn (ERAP) Text Messaging Program - Pain Medication | Pain medication use at 1, 2, and 3 weeks and at 1, 2, and 3 months postop Patient engagement and likelihood to recommend text messaging service | Up to 3 months after surgery | 
| Enhanced Recovery at Penn (ERAP) Text Messaging Program - Engagement | • Patient engagement and likelihood to recommend text messaging service | Up to 3 months after surgery |