Enhanced Recovery After Spine Surgery Randomized Clinical Trial
- Conditions
- ERAS
- Interventions
- Other: ERASS Pathway
- Registration Number
- NCT05830331
- Lead Sponsor
- University of Pennsylvania
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 284
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment ERASS Pathway -
- Primary Outcome Measures
Name Time Method 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
Name Time Method Consults Prior to surgery • Rate of provider recommendation for additional consultations
Opioids Left Over After Surgery up to one month after surgery • Number of pills leftover at one-month timepoint from surgery
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 daysOpioid 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")Enhanced Recovery at Penn (ERAP) Text Messaging Program - Engagement Up to 3 months after surgery • Patient engagement and likelihood to recommend text messaging service
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, 1Usage of Foley During Hospitalization Course from admission to discharge, up to 20 days • Collection of patient use of Foley catheter post-operatively
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 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 surgeryPatient 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.
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 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 serviceTime to Mobilization During Hospitalization post-operative days during hospital admission, up to 20 days • Record time to mobilization and ambulation
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
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 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
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
* KetaminePain 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 scorePatient Falls from admission to discharge, up to 20 days • Collection of total number of inpatient falls
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)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.
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 - 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
Collection of Re-operation After Surgery up to 3 months after surgery • Collection of any reoperations that occurred after the patient's initial surgery
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)
* MorbiditiesCollection 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 regimenCollection 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 treatedDischarge 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.
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.
Trial Locations
- Locations (1)
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States