Enhanced Recovery After Spine Surgery Randomized Clinical Trial (ERASS)

April 13, 2023 updated by: Zarina Ali, University of Pennsylvania

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
284

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control
Experimental: Treatment
Other: ERASS Pathway
Enhanced Recovery After Spinal Surgery

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Opioid use during hospitalization
Time Frame: post-operative days during hospital admission, up to 20 days
Total opioid use during hospitalization after surgery
post-operative days during hospital admission, up to 20 days
Opioid use after surgery
Time Frame: up to one month after surgery
Proportion of patients using opioids one month after surgery
up to one month after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
post-operative days during hospital admission, up to 20 days
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)
from admission to discharge, up to 20 days
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")
post-operative days during hospital admission, up to 20 days
Opioid Refills After Surgery
Time Frame: up to one month after surgery
• Number of times opioid was refilled over 1 month
up to one month after surgery
Opioid Prescribed After Surgery
Time Frame: up to one month after surgery
• Medications and number of pills prescribed at discharge
up to one month after surgery
Opioid Refills (days) After Surgery
Time Frame: up to one month after surgery
• Number of days until 1st, 2nd, and 3rd refill
up to one month after surgery
Opioids Left Over After Surgery
Time Frame: up to one month after surgery
• Number of pills leftover at one-month timepoint from surgery
up to one month after surgery
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
from admission to discharge, up to 20 days
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
post-operative days during hospital admission, up to 20 days
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
from admission to discharge, up to 20 days
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
post-operative days 0 and 1 during hospital admission
Time to Mobilization During Hospitalization
Time Frame: post-operative days during hospital admission, up to 20 days
• Record time to mobilization and ambulation
post-operative days during hospital admission, up to 20 days
Patient Falls
Time Frame: from admission to discharge, up to 20 days
• Collection of total number of inpatient falls
from admission to discharge, up to 20 days
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
from admission to discharge, up to 20 days
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
from admission to discharge, up to 20 days
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
from admission to discharge, up to 20 days
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)
from admission to discharge, up to 20 days
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)
from admission to discharge, up to 20 days
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
from admission to discharge, up to 20 days and up to 6 months after surgery
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
up to 3 months after surgery
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
up to 3 months after surgery
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.
prior to surgery, up to 2-6 weeks after discharge from the hospital
Collection of Discharge Disposition
Time Frame: from admission to discharge, up to 20 days
• Collection of discharge disposition following hospital discharge
from admission to discharge, up to 20 days
Compliance During Hospitalization
Time Frame: from admission to discharge, up to 20 days
  • Compliance with OR checklist
  • Compliance with inpatient ERAS wound care regimen
from admission to discharge, up to 20 days
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.
prior to surgery, up to 6 months after surgery
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.
prior to surgery, up to 6 months after surgery
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.
prior to surgery, up to 6 months after surgery
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.
prior to surgery, up to 6 months after surgery
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.
prior to surgery, up to 6 months after surgery
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
prior to surgery, up to 6 months after surgery
Consults
Time Frame: Prior to surgery
• Rate of provider recommendation for additional consultations
Prior to surgery
Enhanced Recovery at Penn (ERAP) Text Messaging Program - Patient Enrollment
Time Frame: Up to 3 months after surgery
• Patient enrollment in service
Up to 3 months after surgery
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
Up to 3 months after surgery
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
Up to 3 months after surgery
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
Up to 3 months after surgery
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
Up to 3 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pennsylvania

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Neil Malhotra, MD, University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 18, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 13, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 13, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 1, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 26, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 26, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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