Clinical trial NCT05830331: Enhanced Recovery After Spine Surgery Randomized Clinical Trial
Official title: Enhanced Recovery After Spine Surgery (ERASS) Versus Traditional Spine Surgical Care (TC): A Randomized, Prospective Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ERAS
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2023-04-26
Enrollment: 284
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Opioid use during hospitalization
timeFrame: post-operative days during hospital admission, up to 20 days
measure: Opioid use after surgery
timeFrame: up to one month after surgery
Secondary outcomes:
measure: Total Opioid Consumption During Hospitalization Using Morphine Equivalents
timeFrame: post-operative days during hospital admission, up to 20 days
measure: Usage of PCA during hospitalization
timeFrame: from admission to discharge, up to 20 days
measure: Opioid Consumption During Hospitalization
timeFrame: post-operative days during hospital admission, up to 20 days
measure: Opioid Refills After Surgery
timeFrame: up to one month after surgery
measure: Opioid Prescribed After Surgery
timeFrame: up to one month after surgery
measure: Opioid Refills (days) After Surgery
timeFrame: up to one month after surgery
measure: Opioids Left Over After Surgery
timeFrame: up to one month after surgery
measure: Opioid Compliance During Hospitalization
timeFrame: from admission to discharge, up to 20 days
measure: Pain Control Medication Usage
timeFrame: post-operative days during hospital admission, up to 20 days
measure: Pain Control Measurement
timeFrame: from admission to discharge, up to 20 days
measure: Mobilization During Hospitalization
timeFrame: post-operative days 0 and 1 during hospital admission
measure: Time to Mobilization During Hospitalization
timeFrame: post-operative days during hospital admission, up to 20 days
measure: Patient Falls
timeFrame: from admission to discharge, up to 20 days
measure: Usage of Foley During Hospitalization Course
timeFrame: from admission to discharge, up to 20 days
measure: Usage of Straight Catheterization During Hospitalization Course
timeFrame: from admission to discharge, up to 20 days
measure: Collection of Inpatient Status
timeFrame: from admission to discharge, up to 20 days
measure: Length of Stay (days)
timeFrame: from admission to discharge, up to 20 days
measure: Length of Stay (hours)
timeFrame: from admission to discharge, up to 20 days
measure: Collection of Patient Complications
timeFrame: from admission to discharge, up to 20 days and up to 6 months after surgery
measure: Collection of Patient Re-admissions After Discharge
timeFrame: up to 3 months after surgery
measure: Collection of Re-operation After Surgery
timeFrame: up to 3 months after surgery
measure: Discharge Follow Up Questionnaire
timeFrame: prior to surgery, up to 2-6 weeks after discharge from the hospital
measure: Collection of Discharge Disposition
timeFrame: from admission to discharge, up to 20 days
measure: Compliance During Hospitalization
timeFrame: from admission to discharge, up to 20 days
measure: Patient Reported Outcomes EQ-5D
timeFrame: prior to surgery, up to 6 months after surgery
measure: Patient Reported Outcomes EQ-5D (health scale)
timeFrame: prior to surgery, up to 6 months after surgery
measure: Patient Reported Outcomes Oswestry Low Back Pain Disability Questionnaire
timeFrame: prior to surgery, up to 6 months after surgery
measure: Patient Reported Outcomes Neck Disability Index
timeFrame: prior to surgery, up to 6 months after surgery
measure: Patient Reported Outcomes Neurosurgery Patient Satisfaction
timeFrame: prior to surgery, up to 6 months after surgery
measure: Collection of Working Status
timeFrame: prior to surgery, up to 6 months after surgery
measure: Consults
timeFrame: Prior to surgery
measure: Enhanced Recovery at Penn (ERAP) Text Messaging Program - Patient Enrollment
timeFrame: Up to 3 months after surgery
measure: Enhanced Recovery at Penn (ERAP) Text Messaging Program - Compliance
timeFrame: Up to 3 months after surgery
measure: Enhanced Recovery at Penn (ERAP) Text Messaging Program - Pain Score
timeFrame: Up to 3 months after surgery
measure: Enhanced Recovery at Penn (ERAP) Text Messaging Program - Pain Medication
timeFrame: Up to 3 months after surgery
measure: Enhanced Recovery at Penn (ERAP) Text Messaging Program - Engagement
timeFrame: Up to 3 months after surgery
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Zarina Ali, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Neil Malhotra, MD
role: PRINCIPAL_INVESTIGATOR
References: