ERASERASSNCT05830331
Enhanced Recovery After Spine Surgery Randomized Clinical Trial
A study testing ERASS Pathway in people with ERAS, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ERAS
- What is being tested?
- ERASS Pathway
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2019to 13 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19102
About this study
Official title: 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.
- Conditions
- ERAS
- Being tested
- ERASS Pathway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERASS PathwayOther
Enhanced Recovery After Spinal Surgery
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Treatment | Experimental | Not described Receives: Other: ERASS Pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid use during hospitalization
Total opioid use during hospitalization after surgery
Measured: post-operative days during hospital admission, up to 20 days
Opioid use after surgery
Proportion of patients using opioids one month after surgery
Measured: up to one month after surgery
Secondary outcomes (36)
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
Measured: 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)
Measured: 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")
Measured: post-operative days during hospital admission, up to 20 days
Opioid Refills After Surgery
- Number of times opioid was refilled over 1 month
Measured: up to one month after surgery
Opioid Prescribed After Surgery
- Medications and number of pills prescribed at discharge
Measured: up to one month after surgery
Opioid Refills (days) After Surgery
- Number of days until 1st, 2nd, and 3rd refill
Measured: up to one month after surgery
Opioids Left Over After Surgery
- Number of pills leftover at one-month timepoint from surgery
Measured: up to one month after surgery
Opioid Compliance During Hospitalization
- Compliance with inpatient Enhanced Recovery After Surgery (ERAS) multimodal pain regimen
Measured: 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
Measured: 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
Measured: 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
Measured: post-operative days 0 and 1 during hospital admission
Time to Mobilization During Hospitalization
- Record time to mobilization and ambulation
Measured: post-operative days during hospital admission, up to 20 days
Patient Falls
- Collection of total number of inpatient falls
Measured: from admission to discharge, up to 20 days
Usage of Foley During Hospitalization Course
- Collection of patient use of Foley catheter post-operatively
Measured: from admission to discharge, up to 20 days
Usage of Straight Catheterization During Hospitalization Course
- Collection of patient use for straight catheterization post-operatively
Measured: from admission to discharge, up to 20 days
Collection of Inpatient Status
- Collection of patient hospitalization status post-operatively including: inpatient, outpatient and observational
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: up to 3 months after surgery
Collection of Re-operation After Surgery
- Collection of any reoperations that occurred after the patient's initial surgery
Measured: 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.
Measured: prior to surgery, up to 2-6 weeks after discharge from the hospital
Collection of Discharge Disposition
- Collection of discharge disposition following hospital discharge
Measured: from admission to discharge, up to 20 days
Compliance During Hospitalization
- Compliance with OR checklist
- Compliance with inpatient ERAS wound care regimen
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: prior to surgery, up to 6 months after surgery
Consults
- Rate of provider recommendation for additional consultations
Measured: Prior to surgery
Enhanced Recovery at Penn (ERAP) Text Messaging Program - Patient Enrollment
- Patient enrollment in service
Measured: Up to 3 months after surgery
Enhanced Recovery at Penn (ERAP) Text Messaging Program - Compliance
- ERAP compliance with carbohydrate loading and surgical site preparation
Measured: 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
Measured: 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
Measured: Up to 3 months after surgery
Enhanced Recovery at Penn (ERAP) Text Messaging Program - Engagement
- Patient engagement and likelihood to recommend text messaging service
Measured: Up to 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start18 Feb 2019
- Primary completion13 Nov 2020
- Study completion13 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ERASStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zarina Ali, University of Pennsylvania
- Investigators
- Zarina Ali, MD, Principal investigator, University of PennsylvaniaNeil Malhotra, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05830331
- Sponsor's protocol ID
- 831303
- Acronym
- ERASS
- Status last verified
- Apr 2023
- First submitted
- 1 Mar 2023
- Last updated
- 26 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Recovery After Spine Surgery (ERASS) Versus Traditional Spine Surgical Care (TC): A Randomized, Prospective Trial
- ClinicalTrials.gov ID
- NCT05830331
- Acronym / sponsor ID
- ERASS / 831303
- Conditions
- ERAS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 18 Feb 2019 (actual)
- Primary completion
- 13 Nov 2020 (actual)
- Study completion
- 13 Oct 2021 (actual)
- First posted
- 26 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Treatment | Experimental | Other: ERASS Pathway |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- Patients who are pregnant
- Incarceration
- Patients under the age of 18
- Patients unable to participate in the consent procedure
- Patients undergoing emergent surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERASS PathwayEnhanced Recovery After Spinal Surgery | Other | Treatment |
Primary outcome
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
36 secondary outcomes
Total Opioid Consumption During Hospitalization Using Morphine Equivalents
Time frame: 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
Opioid Consumption During Hospitalization
Time frame: post-operative days during hospital admission, up to 20 days
Opioid Refills After Surgery
Time frame: up to one month after surgery
Opioid Prescribed After Surgery
Time frame: up to one month after surgery
Opioid Refills (days) After Surgery
Time frame: up to one month after surgery
Opioids Left Over After Surgery
Time frame: up to one month after surgery
Opioid Compliance During Hospitalization
Time frame: from admission to discharge, up to 20 days
Pain Control Medication Usage
Time frame: post-operative days during hospital admission, up to 20 days
Pain Control Measurement
Time frame: from admission to discharge, up to 20 days
Mobilization During Hospitalization
Time frame: 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
Patient Falls
Time frame: from admission to discharge, up to 20 days
Usage of Foley During Hospitalization Course
Time frame: 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 Inpatient Status
Time frame: from admission to discharge, up to 20 days
Length of Stay (days)
Time frame: from admission to discharge, up to 20 days
Length of Stay (hours)
Time frame: 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 Patient Re-admissions After Discharge
Time frame: up to 3 months after surgery
Collection of Re-operation After Surgery
Time frame: 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
Collection of Discharge Disposition
Time frame: from admission to discharge, up to 20 days
Compliance During Hospitalization
Time frame: from admission to discharge, up to 20 days
Patient Reported Outcomes EQ-5D
Time frame: 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
Patient Reported Outcomes Oswestry Low Back Pain Disability Questionnaire
Time frame: 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
Patient Reported Outcomes Neurosurgery Patient Satisfaction
Time frame: prior to surgery, up to 6 months after surgery
Collection of Working Status
Time frame: prior to surgery, up to 6 months after surgery
Consults
Time frame: Prior to surgery
Enhanced Recovery at Penn (ERAP) Text Messaging Program - Patient Enrollment
Time frame: Up to 3 months after surgery
Enhanced Recovery at Penn (ERAP) Text Messaging Program - Compliance
Time frame: Up to 3 months after surgery
Enhanced Recovery at Penn (ERAP) Text Messaging Program - Pain Score
Time frame: Up to 3 months after surgery
Enhanced Recovery at Penn (ERAP) Text Messaging Program - Pain Medication
Time frame: Up to 3 months after surgery
Enhanced Recovery at Penn (ERAP) Text Messaging Program - Engagement
Time frame: Up to 3 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zarina Ali, MD principal investigator
University of Pennsylvania
Neil Malhotra, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERASS Pathway in people with ERAS, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid use during hospitalization (time frame: post-operative days during hospital admission, up to 20 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2023.