Enhanced Recovery After Spine Surgery Randomized Clinical Trial (ERASS)

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

Study Overview

• Status: Completed
• Conditions: ERAS
• Intervention / Treatment: Other: ERASS Pathway

• Study Type: Interventional
• Enrollment (Actual): 284
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19102
      • Hospital of the University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: Treatment	Other: ERASS Pathway; Enhanced Recovery After Spinal Surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid use during hospitalization	Total opioid use during hospitalization after surgery	post-operative days during hospital admission, up to 20 days
Opioid use after surgery	Proportion of patients using opioids one month after surgery	up to one month after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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)	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")	post-operative days during hospital admission, up to 20 days
Opioid Refills After Surgery	• Number of times opioid was refilled over 1 month	up to one month after surgery
Opioid Prescribed After Surgery	• Medications and number of pills prescribed at discharge	up to one month after surgery
Opioid Refills (days) After Surgery	• Number of days until 1st, 2nd, and 3rd refill	up to one month after surgery
Opioids Left Over After Surgery	• Number of pills leftover at one-month timepoint from surgery	up to one month after surgery
Opioid Compliance During Hospitalization	• Compliance with inpatient Enhanced Recovery After Surgery (ERAS) multimodal pain regimen	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	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	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	post-operative days 0 and 1 during hospital admission
Time to Mobilization During Hospitalization	• Record time to mobilization and ambulation	post-operative days during hospital admission, up to 20 days
Patient Falls	• Collection of total number of inpatient falls	from admission to discharge, up to 20 days
Usage of Foley During Hospitalization Course	• Collection of patient use of Foley catheter post-operatively	from admission to discharge, up to 20 days
Usage of Straight Catheterization During Hospitalization Course	• Collection of patient use for straight catheterization post-operatively	from admission to discharge, up to 20 days
Collection of Inpatient Status	• Collection of patient hospitalization status post-operatively including: inpatient, outpatient and observational	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)	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)	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	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	up to 3 months after surgery
Collection of Re-operation After Surgery	• Collection of any reoperations that occurred after the patient's initial surgery	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.	prior to surgery, up to 2-6 weeks after discharge from the hospital
Collection of Discharge Disposition	• Collection of discharge disposition following hospital discharge	from admission to discharge, up to 20 days
Compliance During Hospitalization	Compliance with OR checklist; Compliance with inpatient ERAS wound care regimen	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.	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.	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.	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.	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.	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	prior to surgery, up to 6 months after surgery
Consults	• Rate of provider recommendation for additional consultations	Prior to surgery
Enhanced Recovery at Penn (ERAP) Text Messaging Program - Patient Enrollment	• Patient enrollment in service	Up to 3 months after surgery
Enhanced Recovery at Penn (ERAP) Text Messaging Program - Compliance	• ERAP compliance with carbohydrate loading and surgical site preparation	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	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	Up to 3 months after surgery
Enhanced Recovery at Penn (ERAP) Text Messaging Program - Engagement	• Patient engagement and likelihood to recommend text messaging service	Up to 3 months after surgery

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Principal Investigator: Neil Malhotra, MD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2019
• Primary Completion (Actual): November 13, 2020
• Study Completion (Actual): October 13, 2021

Study Registration Dates

• First Submitted: March 1, 2023
• First Submitted That Met QC Criteria: April 13, 2023
• First Posted (Actual): April 26, 2023

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 13, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 831303

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No