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

University of Pennsylvania1 site in 1 country284 target enrollmentFebruary 18, 2019

ConditionsERAS

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: ERAS
Sponsor: University of Pennsylvania
Enrollment: 284
Locations: 1
Primary Endpoint: Opioid use during hospitalization
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 18, 2019

End Date

October 13, 2021

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Pennsylvania

Responsible Party

Principal Investigator

Zarina Ali

Chief, Penn Presbyterian Medical Center Department of Neurosurgery

University of Pennsylvania

Eligibility Criteria

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

Outcomes

Primary Outcomes

Opioid use during hospitalization

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

Total opioid use during hospitalization after surgery

Opioid use after surgery

Time Frame: up to one month after surgery

Proportion of patients using opioids one month after surgery

Secondary Outcomes

Opioids Left Over After Surgery(up to one month after surgery)
Total Opioid Consumption During Hospitalization Using Morphine Equivalents(post-operative days during hospital admission, up to 20 days)
Opioid Consumption During Hospitalization(post-operative days during hospital admission, up to 20 days)
Enhanced Recovery at Penn (ERAP) Text Messaging Program - Engagement(Up to 3 months after surgery)
Mobilization During Hospitalization(post-operative days 0 and 1 during hospital admission)
Usage of Foley During Hospitalization Course(from admission to discharge, up to 20 days)
Length of Stay (hours)(from admission to discharge, up to 20 days)
Collection of Patient Re-admissions After Discharge(up to 3 months after surgery)
Patient Reported Outcomes EQ-5D (health scale)(prior to surgery, up to 6 months after surgery)
Enhanced Recovery at Penn (ERAP) Text Messaging Program - Compliance(Up to 3 months after surgery)
Enhanced Recovery at Penn (ERAP) Text Messaging Program - Pain Medication(Up to 3 months after surgery)
Usage of Straight Catheterization During Hospitalization Course(from admission to discharge, up to 20 days)
Collection of Inpatient Status(from admission to discharge, up to 20 days)
Time to Mobilization During Hospitalization(post-operative days during hospital admission, up to 20 days)
Usage of PCA during hospitalization(from admission to discharge, up to 20 days)
Opioid Refills After Surgery(up to one month after surgery)
Opioid Prescribed After Surgery(up to one month after surgery)
Opioid Refills (days) After Surgery(up to one month after surgery)
Opioid Compliance During Hospitalization(from admission to discharge, up to 20 days)
Pain Control Medication Usage(post-operative days during hospital admission, up to 20 days)
Pain Control Measurement(from admission to discharge, up to 20 days)
Patient Falls(from admission to discharge, up to 20 days)
Length of Stay (days)(from admission to discharge, up to 20 days)
Patient Reported Outcomes Oswestry Low Back Pain Disability Questionnaire(prior to surgery, up to 6 months after surgery)
Patient Reported Outcomes Neck Disability Index(prior to surgery, up to 6 months after surgery)
Patient Reported Outcomes Neurosurgery Patient Satisfaction(prior to surgery, up to 6 months after surgery)
Consults(Prior to surgery)
Enhanced Recovery at Penn (ERAP) Text Messaging Program - Patient Enrollment(Up to 3 months after surgery)
Enhanced Recovery at Penn (ERAP) Text Messaging Program - Pain Score(Up to 3 months after surgery)
Collection of Patient Complications(from admission to discharge, up to 20 days and up to 6 months after surgery)
Collection of Discharge Disposition(from admission to discharge, up to 20 days)
Compliance During Hospitalization(from admission to discharge, up to 20 days)
Collection of Working Status(prior to surgery, up to 6 months after surgery)
Collection of Re-operation After Surgery(up to 3 months after surgery)
Discharge Follow Up Questionnaire(prior to surgery, up to 2-6 weeks after discharge from the hospital)
Patient Reported Outcomes EQ-5D(prior to surgery, up to 6 months after surgery)