An interventional study of ERASS Pathway in ERAS, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-26.
Sponsored by University of Pennsylvania · Not applicable, Interventional, and Other
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.
University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other: ERASS Pathway
Enhanced Recovery After Spinal Surgery
Opioid use during hospitalization
Total opioid use during hospitalization after surgery
Time frame: post-operative days during hospital admission, up to 20 days
Opioid use after surgery
Proportion of patients using opioids one month after surgery
Time frame: up to one month after surgery
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
Time frame: 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)
Time frame: 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")
Time frame: post-operative days during hospital admission, up to 20 days
Opioid Refills After Surgery
• Number of times opioid was refilled over 1 month
Time frame: up to one month after surgery
Opioid Prescribed After Surgery
• Medications and number of pills prescribed at discharge
Time frame: up to one month after surgery
Opioid Refills (days) After Surgery
• Number of days until 1st, 2nd, and 3rd refill
Time frame: up to one month after surgery
Opioids Left Over After Surgery
• Number of pills leftover at one-month timepoint from surgery
Time frame: up to one month after surgery
Opioid Compliance During Hospitalization
• Compliance with inpatient Enhanced Recovery After Surgery (ERAS) multimodal pain regimen
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: post-operative days 0 and 1 during hospital admission
Time to Mobilization During Hospitalization
• Record time to mobilization and ambulation
Time frame: post-operative days during hospital admission, up to 20 days
Patient Falls
• Collection of total number of inpatient falls
Time frame: from admission to discharge, up to 20 days
Usage of Foley During Hospitalization Course
• Collection of patient use of Foley catheter post-operatively
Time frame: from admission to discharge, up to 20 days
Usage of Straight Catheterization During Hospitalization Course
• Collection of patient use for straight catheterization post-operatively
Time frame: from admission to discharge, up to 20 days
Collection of Inpatient Status
• Collection of patient hospitalization status post-operatively including: inpatient, outpatient and observational
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: up to 3 months after surgery
Collection of Re-operation After Surgery
• Collection of any reoperations that occurred after the patient's initial surgery
Time frame: 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.
Time frame: prior to surgery, up to 2-6 weeks after discharge from the hospital
Collection of Discharge Disposition
• Collection of discharge disposition following hospital discharge
Time frame: from admission to discharge, up to 20 days
Compliance During Hospitalization
* Compliance with OR checklist * Compliance with inpatient ERAS wound care regimen
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: prior to surgery, up to 6 months after surgery
Consults
• Rate of provider recommendation for additional consultations
Time frame: Prior to surgery
Enhanced Recovery at Penn (ERAP) Text Messaging Program - Patient Enrollment
• Patient enrollment in service
Time frame: Up to 3 months after surgery
Enhanced Recovery at Penn (ERAP) Text Messaging Program - Compliance
• ERAP compliance with carbohydrate loading and surgical site preparation
Time frame: 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
Time frame: 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
Time frame: Up to 3 months after surgery
Enhanced Recovery at Penn (ERAP) Text Messaging Program - Engagement
• Patient engagement and likelihood to recommend text messaging service
Time frame: Up to 3 months after surgery
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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University of Pennsylvania