Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19102, United States
NCT Number: NCT05830331
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Philadelphia, Pennsylvania, 19102, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Enhanced Recovery After Spinal Surgery
Time frame: post-operative days during hospital admission, up to 20 days
Total opioid use during hospitalization after surgery
Time frame: up to one month after surgery
Proportion of patients using opioids one month after surgery
Time frame: post-operative days during hospital admission, up to 20 days
Time frame: from admission to discharge, up to 20 days
Time frame: post-operative days during hospital admission, up to 20 days
Time frame: up to one month after surgery
Time frame: up to one month after surgery
Time frame: up to one month after surgery
Time frame: up to one month after surgery
Time frame: from admission to discharge, up to 20 days
Time frame: post-operative days during hospital admission, up to 20 days
Total usage of non-opioids medication was collected by mg with the following medications:
Time frame: 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:
Time frame: post-operative days 0 and 1 during hospital admission
Time frame: post-operative days during hospital admission, up to 20 days
Time frame: from admission to discharge, up to 20 days
Time frame: from admission to discharge, up to 20 days
Time frame: from admission to discharge, up to 20 days
Time frame: from admission to discharge, up to 20 days
Time frame: from admission to discharge, up to 20 days
Time frame: from admission to discharge, up to 20 days
Time frame: from admission to discharge, up to 20 days and up to 6 months after surgery
Collection of complications (Yes/No) including:
Time frame: up to 3 months after surgery
Time frame: up to 3 months after surgery
Time frame: 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.
Time frame: from admission to discharge, up to 20 days
Time frame: from admission to discharge, up to 20 days
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: prior to surgery, up to 6 months after surgery
Collection of patient working status including:
Time frame: Prior to surgery
Time frame: Up to 3 months after surgery
Time frame: Up to 3 months after surgery
Time frame: Up to 3 months after surgery
Time frame: Up to 3 months after surgery
Time frame: Up to 3 months after surgery
University of Pennsylvania
Other
Enhanced Recovery After Spine Surgery (ERASS) Versus Traditional Spine Surgical Care (TC): A Randomized, Prospective Trial
Acronym: ERASS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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