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OpenTrials
Completed

NCT Number: NCT05830331

Enhanced Recovery After Spine Surgery Randomized Clinical Trial

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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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19102, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ERASS Pathway

Other

Enhanced Recovery After Spinal Surgery

Primary outcomes

  1. Opioid use during hospitalization

    Time frame: post-operative days during hospital admission, up to 20 days

    Total opioid use during hospitalization after surgery

  2. Opioid use after surgery

    Time frame: up to one month after surgery

    Proportion of patients using opioids one month after surgery

Secondary outcomes

  1. Total Opioid Consumption During Hospitalization Using Morphine Equivalents

    Time frame: 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
  2. Usage of PCA during hospitalization

    Time frame: from admission to discharge, up to 20 days

    • Patient-controlled analgesia (PCA) use (collected mg per hour and morphine equivalent)
  3. Opioid Consumption During Hospitalization

    Time frame: 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")
  4. Opioid Refills After Surgery

    Time frame: up to one month after surgery

    • Number of times opioid was refilled over 1 month
  5. Opioid Prescribed After Surgery

    Time frame: up to one month after surgery

    • Medications and number of pills prescribed at discharge
  6. Opioid Refills (days) After Surgery

    Time frame: up to one month after surgery

    • Number of days until 1st, 2nd, and 3rd refill
  7. Opioids Left Over After Surgery

    Time frame: up to one month after surgery

    • Number of pills leftover at one-month timepoint from surgery
  8. Opioid Compliance During Hospitalization

    Time frame: from admission to discharge, up to 20 days

    • Compliance with inpatient Enhanced Recovery After Surgery (ERAS) multimodal pain regimen
  9. Pain Control Medication Usage

    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:

    • Acetaminophen
    • Dexamethasone
    • Lidocaine/ Lidoderm
    • Toradol
    • Valium
    • Flexeril
    • Gabapentin
    • Pregabalin
    • Ketamine
  10. Pain Control Measurement

    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:

    • Preop pain score
    • Discharge pain score
    • Average pain score
    • Minimum pain score
    • Maximum pain score
  11. Mobilization During Hospitalization

    Time frame: 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
  12. Time to Mobilization During Hospitalization

    Time frame: post-operative days during hospital admission, up to 20 days

    • Record time to mobilization and ambulation
  13. Patient Falls

    Time frame: from admission to discharge, up to 20 days

    • Collection of total number of inpatient falls
  14. Usage of Foley During Hospitalization Course

    Time frame: from admission to discharge, up to 20 days

    • Collection of patient use of Foley catheter post-operatively
  15. Usage of Straight Catheterization During Hospitalization Course

    Time frame: from admission to discharge, up to 20 days

    • Collection of patient use for straight catheterization post-operatively
  16. Collection of Inpatient Status

    Time frame: from admission to discharge, up to 20 days

    • Collection of patient hospitalization status post-operatively including: inpatient, outpatient and observational
  17. Length of Stay (days)

    Time frame: 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)
  18. Length of Stay (hours)

    Time frame: 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)
  19. Collection of Patient Complications

    Time frame: 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
  20. Collection of Patient Re-admissions After Discharge

    Time frame: up to 3 months after surgery

    • Collection of patient re-admission 30-days after surgery
    • Collection of patient re-admission 90-days after surgery
  21. Collection of Re-operation After Surgery

    Time frame: up to 3 months after surgery

    • Collection of any reoperations that occurred after the patient's initial surgery
  22. Discharge Follow Up Questionnaire

    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.

  23. Collection of Discharge Disposition

    Time frame: from admission to discharge, up to 20 days

    • Collection of discharge disposition following hospital discharge
  24. Compliance During Hospitalization

    Time frame: from admission to discharge, up to 20 days

    • Compliance with OR checklist
    • Compliance with inpatient ERAS wound care regimen
  25. Patient Reported Outcomes EQ-5D

    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.

  26. Patient Reported Outcomes EQ-5D (health scale)

    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.

  27. Patient Reported Outcomes Oswestry Low Back Pain Disability Questionnaire

    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.

  28. Patient Reported Outcomes Neck Disability Index

    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.

  29. Patient Reported Outcomes Neurosurgery Patient Satisfaction

    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.

  30. Collection of Working Status

    Time frame: 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
  31. Consults

    Time frame: Prior to surgery

    • Rate of provider recommendation for additional consultations
  32. Enhanced Recovery at Penn (ERAP) Text Messaging Program - Patient Enrollment

    Time frame: Up to 3 months after surgery

    • Patient enrollment in service
  33. Enhanced Recovery at Penn (ERAP) Text Messaging Program - Compliance

    Time frame: Up to 3 months after surgery

    • ERAP compliance with carbohydrate loading and surgical site preparation
  34. Enhanced Recovery at Penn (ERAP) Text Messaging Program - Pain Score

    Time frame: 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
  35. Enhanced Recovery at Penn (ERAP) Text Messaging Program - Pain Medication

    Time frame: 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
  36. Enhanced Recovery at Penn (ERAP) Text Messaging Program - Engagement

    Time frame: Up to 3 months after surgery

    • Patient engagement and likelihood to recommend text messaging service

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Acronym: ERASS

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Apr 26, 2023
Registry last updated
Apr 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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