ERASS: Enhanced Recovery After Spine Surgery Randomized Clinical Trial
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Control
|
|
| Experimental: Treatment
|
Other: ERASS Pathway
Enhanced Recovery After Spinal Surgery
|
Outcome Measures
Primary Outcome Measures
- Opioid use during hospitalization [post-operative days during hospital admission, up to 20 days]
Total opioid use during hospitalization after surgery
- Opioid use after surgery [up to one month after surgery]
Proportion of patients using opioids one month after surgery
Secondary Outcome Measures
- Total Opioid Consumption During Hospitalization Using Morphine Equivalents [post-operative days during hospital admission, up to 20 days]
Total morphine equivalents for each post-operative day (POD) 0, 1, 2, 3...21+ Total morphine equivalents for all post-operative days
- Usage of PCA during hospitalization [from admission to discharge, up to 20 days]
• Patient-controlled analgesia (PCA) use (collected mg per hour and morphine equivalent)
- Opioid Consumption During Hospitalization [post-operative days during hospital admission, up to 20 days]
Use of intravenous (IV) narcotics (collected by "Yes" or "No") Use of Narcan/Naloxon (collected by "Yes" or "No")
- Opioid Refills After Surgery [up to one month after surgery]
• Number of times opioid was refilled over 1 month
- Opioid Prescribed After Surgery [up to one month after surgery]
• Medications and number of pills prescribed at discharge
- Opioid Refills (days) After Surgery [up to one month after surgery]
• Number of days until 1st, 2nd, and 3rd refill
- Opioids Left Over After Surgery [up to one month after surgery]
• Number of pills leftover at one-month timepoint from surgery
- Opioid Compliance During Hospitalization [from admission to discharge, up to 20 days]
• Compliance with inpatient Enhanced Recovery After Surgery (ERAS) multimodal pain regimen
- Pain Control Medication Usage [post-operative days during hospital admission, up to 20 days]
Total usage of non-opioids medication was collected by mg with the following medications: Acetaminophen Dexamethasone Lidocaine/ Lidoderm Toradol Valium Flexeril Gabapentin Pregabalin Ketamine
- Pain Control Measurement [from admission to discharge, up to 20 days]
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
- Mobilization During Hospitalization [post-operative days 0 and 1 during hospital admission]
Collection of patient mobilization post-operative day (POD) 0, 1 Collection of patient ambulation post-operative day (POD) 0, 1
- Time to Mobilization During Hospitalization [post-operative days during hospital admission, up to 20 days]
• Record time to mobilization and ambulation
- Patient Falls [from admission to discharge, up to 20 days]
• Collection of total number of inpatient falls
- Usage of Foley During Hospitalization Course [from admission to discharge, up to 20 days]
• Collection of patient use of Foley catheter post-operatively
- Usage of Straight Catheterization During Hospitalization Course [from admission to discharge, up to 20 days]
• Collection of patient use for straight catheterization post-operatively
- Collection of Inpatient Status [from admission to discharge, up to 20 days]
• Collection of patient hospitalization status post-operatively including: inpatient, outpatient and observational
- Length of Stay (days) [from admission to discharge, up to 20 days]
Total length of stay (days) in hospital Total length of stay (days) in intensive care unit (ICU)
- Length of Stay (hours) [from admission to discharge, up to 20 days]
Total length of stay (hours) in hospital Total length of stay (hours) in intensive care unit (ICU)
- Collection of Patient Complications [from admission to discharge, up to 20 days and up to 6 months after surgery]
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
- Collection of Patient Re-admissions After Discharge [up to 3 months after surgery]
Collection of patient re-admission 30-days after surgery Collection of patient re-admission 90-days after surgery
- Collection of Re-operation After Surgery [up to 3 months after surgery]
• Collection of any reoperations that occurred after the patient's initial surgery
- Discharge Follow Up Questionnaire [prior to surgery, up to 2-6 weeks after discharge from the hospital]
Measured with "Yes" or "No", patients were asked if they completed Enhanced Recovery After Surgery (ERAS) protocols and prior to surgery.
- Collection of Discharge Disposition [from admission to discharge, up to 20 days]
• Collection of discharge disposition following hospital discharge
- Compliance During Hospitalization [from admission to discharge, up to 20 days]
Compliance with OR checklist Compliance with inpatient ERAS wound care regimen
- Patient Reported Outcomes EQ-5D [prior to surgery, up to 6 months after surgery]
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.
- Patient Reported Outcomes EQ-5D (health scale) [prior to surgery, up to 6 months after surgery]
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.
- Patient Reported Outcomes Oswestry Low Back Pain Disability Questionnaire [prior to surgery, up to 6 months after surgery]
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.
- Patient Reported Outcomes Neck Disability Index [prior to surgery, up to 6 months after surgery]
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.
- Patient Reported Outcomes Neurosurgery Patient Satisfaction [prior to surgery, up to 6 months after surgery]
Using the Neurosurgery Patient Satisfaction Outcome questionnaire, patients' satisfaction are recorded with "Yes" or "No" to questions.
- Collection of Working Status [prior to surgery, up to 6 months after surgery]
Collection of patient working status including: currently working retired disabled not working due to a reason other than the condition being treated
- Consults [Prior to surgery]
• Rate of provider recommendation for additional consultations
- Enhanced Recovery at Penn (ERAP) Text Messaging Program - Patient Enrollment [Up to 3 months after surgery]
• Patient enrollment in service
- Enhanced Recovery at Penn (ERAP) Text Messaging Program - Compliance [Up to 3 months after surgery]
• ERAP compliance with carbohydrate loading and surgical site preparation
- Enhanced Recovery at Penn (ERAP) Text Messaging Program - Pain Score [Up to 3 months after surgery]
• 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
- Enhanced Recovery at Penn (ERAP) Text Messaging Program - Pain Medication [Up to 3 months after surgery]
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
- Enhanced Recovery at Penn (ERAP) Text Messaging Program - Engagement [Up to 3 months after surgery]
• Patient engagement and likelihood to recommend text messaging service
Eligibility Criteria
Criteria
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
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Patients undergoing emergent surgery
-
Patients with liver disease
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19102 |
Sponsors and Collaborators
- University of Pennsylvania
Investigators
- Principal Investigator: Zarina Ali, MD, University of Pennsylvania
- Principal Investigator: Neil Malhotra, MD, University of Pennsylvania
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 831303